San Diego Beach Blanket Biotech

Cibus Leverages Nature to Change Plant Traits

2011-02-15T08:55:00.001-08:00

"Cibus is not inserting a foreign gene into a plant species...it uses a simple gene repair mechanism to change a single letter in a single base pair of the gene that controls a particular trait" - Xconomy

“We welcome this important contribution to the growing debate around the challenges of meeting the food needs of a rapidly rising global population. We believe that Cibus’ RTDS system, by using the basic processes of natural selection, has an invaluable role to play in helping farmers in all parts of the world to improve yields across a wide range of crops and plants, while respecting traditional boundaries and the environment. We look forward to working with farmers, companies, governments and NGO’s in helping to meet these challenges.” - Keith Walker, President, Cibus Global

RTDS - introduces gene traits through a natural repair mechanism that is already part of the plant. It is a process that leverages natural selection and is a natural process. Traditional plant breeding is slow and "hit or miss" while the RTDS process is more exact. RTDS nudges the plant to repair naturally occurring gene mutations in a controlled manor instead of randomly. Nothing in the genome is changed, it's just pushed in a direction that gives a more direct result toward the desired effect. The specific desired effects Cibus is trying to create are pesticide resistant Flax and Canola.

Vertex's Hep C Drug Telaprevir Cured 65% of Patients Compared with 17%

2010-09-10T08:17:00.000-07:00

"Vertex’s medicine, telaprevir, added to standard treatments for the infection, cured 65 percent of patients overall compared with 17 percent on the other regimen alone.

No proven medicines are available for hepatitis C patients who don’t respond to standard care.

“Today’s results give people who haven’t achieved success with prior treatments some real hope for having a cure,” Robert Kauffman, the chief medical officer for Vertex, said today in a telephone interview."

http://www.bloomberg.com/news/2010-09-07/vertex-j-j-hepatitis-c-drug-works-after-others-fail.html

About the Study

REALIZE was a pivotal Phase 3, randomized, double-blind, placebo-controlled study conducted in 662 people at more than 100 international clinical trial sites with the majority in Europe and North America. The study was designed to evaluate the efficacy, safety and tolerability of telaprevir-based regimens in people infected with genotype 1 chronic hepatitis C who did not achieve a viral cure after at least one prior treatment with interferon-based therapy. There were two telaprevir-based arms (simultaneous and delayed start) and one control arm. Patients were randomized 2:2:1 to the two telaprevir arms and the control arm, respectively.

http://investors.vrtx.com/releasedetail.cfm?ReleaseID=505239

Senomyx Enters Into Collaboration with Pepsi

2010-09-10T00:34:00.000-07:00

"PepsiCo's collaboration with Senomyx will focus on the discovery, development and commercialization of sweet enhancers and natural high-potency sweeteners with the intent to bring to the marketplace lower-calorie, great tasting PepsiCo beverages. The agreement reflects the companies' shared commitment to offer healthier products to consumers that maintain the sweet taste they want.

The real challenge is to create products that not only are healthier but also taste great, and Senomyx has unique technologies that will allow us to improve the nutritional profile of our products without sacrificing taste. We're very optimistic that this collaboration will help us achieve our commitment to reduce added sugar per serving by 25 percent in key brands in key markets over the next decade and ultimately help people around the world live healthier lives."

http://www.beverageworld.com/index.php?option=com_content&view=article&id=38209&catid=3&Itemid=173

Vical Incorporated Releasing Phase 2 Data on DNA Vaccine to Prevent Cytomegalovirus

2010-09-09T08:06:00.000-07:00

Vical Incorporated (Nasdaq:VICL) today announced plans to present final results from the company's Phase 2 trial evaluating the potential for its TransVax™ therapeutic DNA vaccine to prevent cytomegalovirus (CMV) reactivation and disease in immunosuppressed hematopoietic cell transplant (HCT) recipients. The company's abstract was accepted for a late-breaker session at the 50^th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC, Boston – September 12-15).

Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs. Additional information on Vical is available at www.vical.com.

http://www.globenewswire.com/newsroom/news.html?ref=rss&d=201111

Stemedica Cell Technologies wants to use Bone Marrow Cells to Treat Stroke

2010-09-08T22:22:00.000-07:00

Stemedica Cell Technologies, has requested a pre-Investigational New Drug (IND) meeting with the FDA to discuss a proposed New Drug by Stemedica that is a line of allogeneic mesenchymal bone marrow cells (adult human) as a treatment for ischemic stroke.

"Treatment with allogeneic mesenchymal bone marrow cells may offer new hope to patients with chronic neurological or age-related, neurodegenerative diseases."

"Transplantation of mesenchymal stem cells(MSCs) has been shown to improve neurological deficits afterstroke in rats." - Stroke. 2005;36:853-858

"Stemedica Cell Technologies, Inc. was founded as the result of a personal commitment by Executive Chairman Roger Howe and CEO Maynard Howe to find alternative therapy for a family member who had been left paralyzed from an automobile accident and whose recovery through stem cell therapy provided the impetus for establishing Stemedica.
The Company was formally incorporated in 2005 by a group of prominent scientists, leading clinicians, experienced investors and executives from successful medical, biotechnology and pharmaceutical businesses. Stemedica is a specialty biopharmaceutical company that is committed to the development and manufacture of best-in-class adult stem cells for use by approved research institutions and hospitals for pre-clinical and clinical studies.
Within the United States, the Company is currently developing regulatory pathways for traumatic brain injury and wound repair. Outside the United States, Stemedica provides its adult stem cells to hospitals and research centers that are conducting studies under protocols approved by the appropriate regulatory agencies. These studies are focused on the treatment of neurodegenerative disease, sight restoration and wound repair." http://www.stemedica.com/company/

Antibodies by BD Biosciences used in Lupus Study

2010-09-07T14:47:00.000-07:00

Accumulating evidence suggests that dysfunction of T cells underlies the pathogenesis of systemic lupus erythematosus (SLE). We revealed that SLE T cells produced an abnormally excessive amount of IFN-γin vitro upon stimulation through TCR, and the expression level of TCR zeta was significantly reduced. The production of IFN-γ by SLE T cells was negatively correlated with the expression level of TCR zeta. This correlation was abolished when the cells were stimulated with TPA and ionomycin, which bypass TCR and introduce signals directly into the cells, but the production of IFN-γ by SLE T cells remained abnormally elevated. Taken together, these data suggest that regulatory mechanisms not only for the expression of TCR zeta but also for the production of IFN-γ were impaired in SLE T cells. These impairments may be responsible for the aberrant responses of SLE T cells and partly involved in the development of SLE.

Antibodies against CD3 (HIT3a), IL-2 (MQ1-17H12 and B33-2), and IFN- (B27 and 4S.B3) were purchased from BD Biosciences Pharmingen (San Diego, USA.)

Journal of Biomedicine and Biotechnology
Volume 2010 (2010), Article ID 509021, 6 pages
doi:10.1155/2010/509021


Reduced Expression of TCR Zeta Is Involved in the Abnormal Production of Cytokines by Peripheral T Cells of Patients with Systemic Lupus Erythematosus

BD Biosciences Alexa Fluor® 700 Rat Anti-Mouse CD3 Molecular Complex

2010-08-26T08:08:00.000-07:00

Alexa Fluor® 700 Rat Anti-Mouse CD3 Molecular Complex

The 17A2 monoclonal antibody specifically binds to the T-cell receptor-associated CD3 complex that is expressed on many thymocytes and mature T lymphocytes. Plate-bound 17A2 antibody has been reported to induce IL-2 production by cultured T cells in the absence of accessory cells. The binding of the 17A2 antibody to T cells can be blocked by the anti-CD3e mAb 145-2C11. This suggests that the 17A2 antibody recognizes an epitope of the CD3 epsilon chain. In vivo treatment with 17A2 antibody has been reported to partially deplete T lymphocytes and temporarily down-modulates CD3 expression on T cells.

http://www.bdbiosciences.com/ptProduct.jsp?prodId=790111&catyId=783553&page=product

Eppendorf launches the first segmented PCR plate

2010-08-26T07:54:00.000-07:00

Eppendorf offers the first two-component PCR plate designed to be easily divisible, saving material and money when running smaller-scale experiments. These twin.tec unskirted 96-well plates fit almost all available PCR instruments and can be snapped into four separate 24-well segments and the empty wells saved for future use.

According to Dr Kay Koerner, Senior Product Manager PCR at Eppendorf AG, ‘Most of the time our customers do not fill up an entire 96-well PCR plate, and leaving the remaining wells empty is a waste of material and money. However, cutting PCR plates into pieces with scissors seemed to us an inappropriate solution, so we invented the first divisible two-component PCR plate. These new 96-well twin.tec plates can simply be snapped into pre-defined segments so that 24, 48 or 72 wells can be used as required – reducing waste and bringing significant cost savings.’

Eppendorf twin.tec PCR plates bring all the advantages that come from combining two materials. The frame is manufactured from rigid polycarbonate for enhanced mechanical stability, while the flexible polypropylene wells are thin-walled to ensure a snug fit to the thermal block for optimal heat transfer. The inert surface of the wells prevents DNA, RNA and enzymes from binding and improves recovery when working with small volumes.

http://www.eppendorfna.com/int/index.php?l=131&sitemap=5.1&action=news&contentid=1&pb=34825be1e60ae60d&itemid=18967

Imgenex MyD88 mAb (Clone 4D6) involved in Inflammatory Mediator Gene

2010-08-26T07:52:00.000-07:00

MyD88 is a major adaptor molecule involved in TLR, IL-1 and IFNg signaling pathways. Cell activation through TLRs leads to MyD88 mediation of NF-kB as well as Erk, Jnk and p38 signaling pathways involved in inflammatory mediator gene transcription. IFNg activation of MyD88 leads to p38 activation and downstream regulation of TNF and IP-10 transcripts.

The MyD88 specific monoclonal antibody (4D6), along with our other adaptor molecule reagents specific to TRIF, TIRAP, SARM and TRAM, enable development of assays, read-out systems and potential target development for cell signaling, control especially for Western Blot, Flow Cytometry or IHC applications.

http://imgenex.com/view_data_page.php?id=239

BD Biosciences PE Mouse Anti-Human CD16 monoclonal antibody

2010-08-26T07:40:00.000-07:00

PE Mouse Anti-Human CD16 monoclonal antibody

"The B73.1 monoclonal antibody specifically binds to CD16, the 50-70 kDa low affinity receptor for IgG, IgG Fc receptor III (FcγRIII). CD16 is expressed on NK cells, neutrophils, and on a subset of T cells from certain individuals. The B73.1 antibody binds to CD16-positive neutrophils with lower intensity when compared with some other CD16-specific antibodies. A variable number of CD16-positive lymphocytes coexpress either the CD57 antigen or low-density CD8 antigen or both. The B73.1 antibody can block Fc receptor functions mediated by CD16."

CAUTION: B73.1 binding is inhibited by human serum or aggregated IgG. In whole blood preparations, CD16 shows variable reactivity with granulocytes.

http://www.bdbiosciences.com/external_files/pm/doc/tds/human/live/web_enabled/561313.pdf

Positive Phase 2 Data on gout drug RDEA594 by Ardea Biosciences

2010-08-26T07:29:00.000-07:00

Highlights of the new data being presented at EULAR include:
-- Updated results from a Phase 2b monotherapy study of RDEA594 in 123 gout patients demonstrating a 60% response rate at the highest dose tested.
-- Interim results from an ongoing Phase 1b study examining the pharmacokinetics and pharmacodynamics of RDEA594 and allopurinol separately and in combination that demonstrate a 100% response rate in patients receiving two different doses of RDEA594 combined with allopurinol.
-- Results from multiple studies indicating that the efficacy of RDEA594 is not diminished in patients with mild-to-moderate renal impairment.
-- Safety results from five clinical studies indicating that RDEA594 is well tolerated alone or in combination with allopurinol or febuxostat (Uloric®, Takeda Pharmaceutical Company Limited; Adenuric®, Ipsen and Menarini), with no occurrence of drug-related serious adverse events or dose-related side effects.

Read more: http://www.drugs.com/clinical_trials/positive-phase-2-data-rdea594-ardea-biosciences-lead-product-candidate-hyperuricemia-gout-presented-9653.html#ixzz0xiqKX5hN

Abgent & NexBio Combine Forces to Sponsor Viral Infections Study

2010-08-15T21:22:00.000-07:00

Virology Journal 2004, 1:12 doi:10.1186/1743-422X-1-12

Vaccinations are an effective means of making a population immune to a specific viral infection. But effective vaccines are far and in between. An emerging new method of dealing with viruses are combining 2 (two) blocking methods. Blocking the receptor sites the viruses attach themselves to. Or blocking the reproduction of the viruses by blocking the reproductive mechanization of the viruses.

In 2004 the majority of anti-viral biochemical therapeutics in clinical trials were (mAb) monoclonal antibodies. Several are approved by the FDA for Cancer treatment and Autoimmune diseases.

Developing a cure for the common cold is still unfeasible. Developing a vaccine against the cold is not possible yet because the Human rhinovirus (HRV) has 115 antigenically distinct serotypes. A serotype is a grouping of antigens similar to one another. A vaccine would have to block of all 115 serotypes to be effective. There has been some success against the cold. 90% of the serotypes attach to same cell receptor. But that leaves another 11 serotype groups that attack the cell in different regions.

Antisense-oligonucleotides (AS-ONs), ribozymes, and recently, RNA interference (RNAi) are several popular anti-viral strategies used in 2004.

Antisense oligonucleotides are short chains of either RNA or DNA. The RNA version blocks the protein translation of Messenger RNA (mRNA) strands binding to them. Positive-sense viral RNA can be translated by the host-cell because it is similar to mRNA. Antisense oligonucleotides are an anti-viral defense.

Vitravene was the 1st (AS-ONs) drug brought to market. "Vitravene† is indicated for the local treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS), who are intolerant of or have a contraindication to other treatment(s) for CMV retinitis or who were insufficiently responsive to previous treatment(s) for CMV retinitis."

Hairpin ribozymes inhibit the hepatitis B virus (HBV). Ribozymes can target a specific cell to block expression of a gene or genes in the cell are described. Ribozymes along with antisense oligonucleotides can block expression of viral oncogenes that cause cancer.

RNA interference (RNAi) inhibits the expression of specific genes by introducing double-stranded RNAs (dsRNAs). In 2004 it was the method of choice for a quick and effective method of gene repression. Small interfering RNAs (siRNAs) of 21 -23 nucleotides silenced targeted genes without triggering interferon.

Interferons are proteins made up of lymphocytes responding to the presence of pathogens. Many viruses are resistant to interferon. When interferon is taken in drug form several fatiguing side-effects can be triggered.

RNAi can be used for investigational purposes to study expression of specific genes. Studying gene pathways is important for Biotech companies. In 2006 the Nobel Prize was awarded to Andrew Fire and Craig C. Mello for their RNAi work with C. elegans.

RNAi is a natural response to viruses, and also "jumping genes" called transposons also referred to as "junk DNA". The most common form of transposon is the Alu sequence. The Alu sequence is the cause of several inherited cancers. 10.7% of our genome contains Alu sequences. Alu sequences are involved in Breast cancer, Alzheimer's, Lung cancer, Gastric cancer and other diseases.

To date no RNAi drugs are on market but there are 7 firms in development phase.

On 05/05/05 Dharmacon, Inc., the world’s leading supplier of innovative RNA and RNA interference (RNAi) research products, announced today an agreement to deliver a genome-wide short-interfering RNA (siRNA) library covering approximately 22,000 human genes to Millennium Pharmaceuticals, Inc., a leading biopharmaceutical company based in Cambridge, Mass.

The RNAi Global Initiative is a unique alliance of leading international biomedical researchers, and has been established to increase and accelerate the utility of genome-wide siRNA libraries.

Genome-wide siRNA libraries have the potential to fundamentally change biological research by dramatically increasing scientists' ability to understand disease mechanisms and facilitating faster drug discovery and development. The RNAi Global Initiative will provide a forum for member institutions to share research protocols, establish experimental standards and develop mechanisms for exchanging and comparing screening data.

http://www.rnaiglobal.org/about.html

Binding Site Limited Sponsored an Anti-Tetanus study Measuring Antibodies

2010-08-05T10:07:00.000-07:00

The Binding Site Limited with offices in San Diego sponsored a study on the comparison of 5 commercial anti-tetanus toxoid immunoglobulin g enzyme-linked immunosorbent assays.

Clostridium tetani bacteria found in the soil or parasites causes Tetanus. Clostridium tetani enters the body through a wound. Tetanus is also know as lockjaw. It causes muscle spasms leading to respiratory failure and death in 40% of cases if not treated. Tetanus is preventable by a vaccine.

The measurements of anti-tetanus immunoglobulin G (IgG) levels determines the rate of immunity and risk of infection to tetanus. Measuring IgG levels also determines the effectiveness of immunization programs.

The World Health Organization (WHO) guidelines suggest that IgG antibodies above 0.01 IU/ml offer minimum protection and 0.10 IU/ml provide substantial protection. During previous clinical studies on guinea pigs, 13% of those with 0.01 IU/ml showed symptoms of tetanus but survived. A clinical study shows that as much as 10% of immunized people have close to the minimal cutoff of 0.01 IU/ml of antibodies. Hospital visits caused by dirty cuts usually result in a tetanus shot if the patient can't remember the last shot they had. But in third world countries who can't afford to give out tetanus shots to anyone they think might need one, they have to be more stringent with immunization.

ELISA kits are used to measure samples and depending on what brand is used determines the results found. Depending on brand you can get different results. 5 brands of ELISA kits were compared. Euroimmun, Scimedx, Serion-Verion, The Binding Site (TBS), & Genzyme were compared.

ELISA stands for Enzyme-linked immunosorbent assay. ELISA is a technique designed to detect antibodies or antigens. Antibodies are produced by the body to identify and neutralize foreign objects that are antigens like viruses, bacteria or other pathogens. ELISA tests have many applications and are commonly used for drug screenings and pregnancy tests.

One of the problems that causes different results is 3 of the manufactures (Virotech, Serion & Scimedx) being tested can only measure as low as 0.1 IU/ml. Only The Binding Site and Euroimmun assays are designed to detect measurements below 0.1 IU/ml. Both the Euroimmun & Virotech assays had 70% of their samples tested above 0.1 IU/ml compared to The Binding Site & Serion samples where 55% tested above 0.1 IU/ml. The Scimedx kit only measured 15% of it's samples as below 1.0 IU/ml with some samples not being able to detect the sample.

Typically the Euroimmun and Virotech kits measured higher values than The Binding Site and Serion kits. To improve some of the kits sensitivity to the minimal levels (0.01 IU/ml) the scientists raised the sample level 4 fold to get a more accurate test. For some of the results even raising the sample levels 4 fold wasn't good enough to determine an accurate result when detecting the minimal protection level.

Written by Dan Gilliland

Comparison of Five Commercial Anti-Tetanus Toxoid Immunoglobulin G Enzyme-Linked Immunosorbent Assays

CLINICAL AND VACCINE IMMUNOLOGY, Dec. 2009, p. 1837–1839

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http://www.bindingsite.com/tetanustoxoid-154.asp

Tetanus toxoid Assays for immune status or response to vaccination

IgG antibodies to Tetanus toxoid are produced by the immune system following infection with C.tetani (in response to the presence of the toxin), or in response to immunisation with a Tetanus vaccine. The measurement of specific IgG antibodies to Tetanus toxoid pre-vaccination and post-vaccination is important in the assessment of the individual's ability to elicit an immune response to protein antigens. This assay may also be used to determine the immune status of the individual with respect to Tetanus infection.

Illumina GA-II Used in Approach to develop Both Transcriptomic and Genomic Resources

2010-08-04T01:04:00.000-07:00

In a study looking at the adaptability of the Soybean Aphid, the Illumina GA-II genome analyzer along with the Roche-454 were used to determine genetic markers.

Aphids are a common pest and are widely studied but this study focused on the less studied Soybean Aphid which entered North America in 2000. Soy is the 3rd largest crop in the US, so getting a handle on this pest is a priority. The Soybean Aphid is very adaptable and has eluded traditional pest control.

"If genes responsible for biotype adaptation could be identified, it could streamline efforts in developing resistant soybeans."

"The Illumina technology provides high coverage but short reads and is most efficient for species that have substantial sequence information to serve as a reference and aid in assembly." The Illumina GA-II is a faster sequencer than the Roche-454 but the Roche can produce longer sequences. The Illumina GA-II is better to sequence species that have a lot of data already published. The Roche-454 strength for this study is that it can develop a more precise picture of the gene sequence even though it takes longer to produce data than the Illumina.

The researchers found that using both the short, quickly derived gene sequences developed by the Illumina GA-II and the longer, slower produced gene sequences developed by the Roche-454 gave the researchers the most complete results. The research reveled 100s of biomarkers that will be further researched in more detail in the future. This study will provide scientists with many unique genetic targets to focus on to develop an Aphid-resistant Soy.

written by Dan Gilliland

Combining Next-Generation Sequencing Strategies for Rapid Molecular Resource Development from an Invasive Aphid Species, Aphis glycines. PLoS ONE 5(6): e11370. doi:10.1371/journal.pone.0011370

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The Genome Analyzer_IIe sequencing workflow is based on three simple steps. Libraries can be prepared from virtually any nucleic acid sample in less than six hours with standardized, ready-to-use kits. Clonal amplification takes less than four hours, with less than 10 minutes of hands-on time, using the fully automated, emulsion PCR-free cBot cluster generation system. Sequencing is performed inside flow cells using standard sequencing reagents.

http://www.illumina.com/systems/genome_analyzer.ilmn

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The Genome Sequencer FLX Instrument, powered by GS FLX Titanium series reagents, features a groundbreaking combination of long reads, exceptional accuracy and high throughput. The breadth of applications, including de novosequencing, resequencing of whole genomes and target DNA regions, metagenomics and RNA analysis have resulted in hundreds of peer-reviewed publications to date.

http://454.com/products-solutions/system-benefits.asp

Quidel's Strep A Tests Throat Specimens and helps Detect Upper Respiratory Tract Infections

2010-07-22T15:11:00.000-07:00

The most common causes of a sore throat is a viral infections. Group A beta hemolytic streptococci (GABHS) also known as Strep are a common group of viruses that can be involved in throat infections. Strep throat can lead to more serious complications the faster you detect strep the better. Also it is important to detect the strain of the virus or bacteria to determine the best cure.

A Rapid Streptococcal Antigen Test (RSAT) can reduce unnecessary antibiotic use by 2/3.

This study looked at San Diego's Quidel Quickvue Strep A Rapid Streptococcal Antigen Test. The company benchmarked the test as having a specificity of 98% and a sensitivity of 95%. During the test the Quickvue test was put up against the traditional method of a 24 hour cultivation of a culture using sheep's blood.

In the study the Quickvue RSAT had a sensitivity of 64.6% and a specificity of 96.79%. Positive samples were 80.95% accurate and the negative samples were 92.82% accurate.

"It is important that the sensitivity reported as 95% for the kit was detected in our study as 64,6% in routine practices, but this rate was above the lower limit of 58% One of the most important factors affecting the sensitivity of the test is the proper collection of a throat swab."

A curious revelation shows that the results faired better for children compared to adults. Rapid antigen
detection in children were a sensitivity of 70% and a specificity of 90.3%. In adults a sensitivity of 59.4% and a specificity 70.4%. This study does not go into detail looking for a cause for this discrepancy between children and adults

One way to combat the inaccuracy of the swabbing technique is to use double swabs. Studies using double swabs increased sensitivity to 89.1% and a specificity of 95%.

The Rapid Streptococcal Antigen Test gets results quickly compared to a 24 hour wait and another Doctor's visit. It can offer very good benefits to outpatient and clinic situations. To increase accuracy of the test the use of double swabs has to be employed. The education of healthcare personnel is paramount to the success of this quick and easy test. The savings in time, money and unnecessary treatments make it an effective alternative compared to the gold standard of culture cultivation.

International Journal of Pediatric Otorhinolaryngology 74 (2010) 591–593

"The sensitivity and the specifity of rapid antigen test in streptococcal upper respiratory tract infections"

written by Dan Gilliland

GenVault's GenTegra DNA Technology Allows for Room Temperature Nucleic Acid Storage

2010-07-13T21:56:00.000-07:00

Bio-sample storage is expensive and the material eventually does degrade. GenVault has a cost effective alternative for cold storage of bio-samples. The main culprits of Bio-sample destruction are oxidation, heat and hydrolysis. GenVault has a technology that allows for the samples to cool without lowering the temperature by adding special non-toxic chemicals to the mix.

GenVault offers their "FastDryer" to insure the samples are "bone" dry before GenTegra is applied. The GenTegra technology offers near 100% recovery when mixed with standard buffers when brought back to volume for use. To recover, add water and use in downstream applications.

GenTegra is an inorganic mineral mix with antioxidant and antimicrobial properties. GenTegra is supplied as a coating at the bottom of each special GenTegra tube. Each tube can last up to 4 rehydration cycles. Barcodes are used for tracking with barcodes for both tubes and racks.

Curr Issues Mol Biol. 2010;12(3):135-42. Epub 2009 Oct 2

GenVault predicts that the GenTegra RNA can keep samples intact for 29 years when stored at room temperature. You do not have to worry about high shipping temperatures because GenTegra protects above the UPS maximum of 140 F.

GenTegra technology simplifies storage and shipping. No more expensive energy bills for storage or high shipping costs because of dry ice.

A study at Baylor College of Medicine showed that the GenTegra technology did not alter DNA quality or performance in downstream analysis.

GenTegra increases the effectiveness of biobanking and biopreservation of highly sensitive bio-samples that are being used for clinical studies.

Processing delays can cause global gene expression patterns to change when being tested using microarrays.

Barnes, et al. Biopreservation and Biobanking. In press

A study by Barnes, et al looking at background inhibiting the reading of microarray tests showed no real difference with samples stored with GenTegra. "GenTegra does not interfere with labeling or probing of microarrays."

GenVault's GenTegra DNA Technology: YouTube Video

Biomatrica makes room temperature Nucleic Acid storage

2010-07-12T00:07:00.000-07:00

Biomatrica's RNAstable offers researchers the ability to store and transport RNA at room temperature without loss of sample quality, and at significant cost savings on materials, labor and shipping

"Introduction

RNAstable® is a novel preservation product developed to protect RNA from degradation during storage or shipment at ambient temperatures. The synthetic storage medium is based on the natural principles of anhydrobiosis (meaning “life without water”), a biological mechanism employed by some organisms that enables their survival while dry for more than 100 years. Anhydrobiotic organisms protect their DNA, RNA, proteins, membranes and cellular systems for survival in a dry state and can be revived by simple rehydration. RNAstable was designed to mimic these unique characteristics to stabilize RNA at ambient temperatures for prolonged time periods. Quantitative RT-PCR analysis demonstrates successful amplification of RNA templates that were stored dry in RNAstable for 29 months at room temperature and under accelerated aging conditions equivalent to 12 years of room temperature storage (elevated temperatures at 45°C). Samples were sealed inside a moisture-barrier bag including a desiccant pack to ensure ideal storage conditions. Rehydrated samples were used directly in reactions without further purification and exhibited no inhibition or loss of activity. This innovative technology prevents degradation of RNA at room temperature and offers tremendous cost and energy savings as an easy-to-use alternative to conventional freezer storage."

Sharron Ohgi, Laurent Coulon, Rolf Muller, Judy-Muller-Cohn, and Omoshile Clement

BioTechniques, Vol. 48, No. 6, June 2010, p. 470

http://www.biotechniques.com/BiotechniquesJournal/2010/June/Stabilizing-RNA-at-room-temperature-in-RNAstable/biotechniques-296800.html

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Curr Issues Mol Biol. 2010;12(3):135-42. Epub 2009 Oct 2.

Green technologies for room temperature nucleic Acid storage.

Wan E, Akana M, Pons J, Chen J, Musone S, Kwok PY, Liao W.

Cardiovascular Research Institute, University of California, San Francisco, 94143, USA.

RNAstable offers a platform to store samples in an environmentally friendly manner with lower long-term costs.

Halozyme Therapeutics enters Phase 2 Type 2 Diabetes Drug

2010-07-11T19:08:00.000-07:00

SAN DIEGO, June 27 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Nasdaq: HALO) today announced Phase 2 results demonstrating that the subcutaneous coinjection of rHuPH20 (recombinant human hyaluronidase, PH20) with lispro significantly improves postprandial hyperglycemia, reduces hypoglycemia, and accelerates the absorption of mealtime insulin in patients with type 2 diabetes. Significantly more patients receiving lispro+PH20, 71% versus 48%, achieved the American Diabetes Association (ADA) goal of maintaining glucose below 180 mg/dL compared to lispro treatment alone, an indication of reduced hyperglycemia. Fewer patients required treatment for hypoglycemia and the mean minimum concentration for postprandial glucose was significantly higher for the lispro+PH20 combination compared to lispro alone.
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1442388&highlight=
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Review of the mechanism of action and clinical efficacy of recombinant human hyaluronidase coadministration with current prandial insulin formulations.

J Diabetes Sci Technol. 2010 Mar 1;4(2):419-28.

For patients with type 1 or type 2 diabetes, achieving good glycemic control is critical for successful treatment outcomes. As many patients remain unable to reach glycemic goals with currently available rapid-acting analog insulins, ultrafast insulin products are being developed that provide an even faster pharmacokinetic profile compared with current rapid prandial insulin products.

http://www.ncbi.nlm.nih.gov/pubmed/20307403

San Diego-based TargeGen to be purchased by Sanofi-aventis

2010-07-08T07:59:00.000-07:00

BY ANDREW KLESKE,

WEDNESDAY, JUNE 30, 2010 AT 11:41 A.M.

TargeGen's headquarters on Judicial Drive in San Diego.

Local privately held biotech company TargeGen Inc. has agreed to be acquired by international pharmaceutical company Sanofi-aventis for an ultimate price of $560 million.

TargeGen, which focuses on the development of small molecule kinase inhibitors, was founded in 2001 and has been working on treatments for myeloproliferative diseases including primary and secondary myelofibrosis and polycythemia vera. The final purchase price will be dependent on TargeGen drug candidates reaching certain development milestones.

http://www.signonsandiego.com/news/2010/jun/30/san-diego-based-targegen-be-purchased-sanofi-avent/

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In October 2009, TargeGen® completed a Phase 1, multicenter clinical trial of TG101348, an oral, potent, and highly selective inhibitor of JAK2 in patients with myelofibrosis. This study evaluated the safety, tolerability, maximum tolerated dose, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of TG101348. Data from this study will be presented at the American Society of Hematology annual meeting in New Orleans, Louisiana, December 5-8, 2009. Phase II studies are expected to begin in Q3 2010.

http://www.targegen.com/trials.htm

Genzyme and Hospira reach new drug-packaging deal

2010-07-08T06:44:00.000-07:00

(Reuters) - Genzyme Corp (GENZ.O), which is attempting to fix quality-control problems involving its top medicines, will have Hospira Inc (HSP.N) fill and package the drugs under a new supply agreement between the two companies, Genzyme said in a regulatory filing on Wednesday.

Genzyme in May agreed to terms of a consent decree with U.S. regulators over its troubled manufacturing plant in Boston, under which it will pay the government $175 million in profits from past sales of certain drugs.

The consent decree requires Genzyme by November 28 to move filling and packaging operations out of the plant for Cerezyme, the company's treatment for Gaucher disease; Fabrazyme, its treatment for Fabry disease; and Thyrogen, a thyroid drug sold within the United States. The deadline is August 31, 2011 for products sold outside of the United States.

http://www.reuters.com/article/idUSTRE6665QY20100707

----------------------------------------------------------

One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 12,000 employees in locations spanning the globe and 2009 revenues of $4.5 billion.

With many established products and services helping patients in approximately 100 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant and immune disease, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as cardiovascular disease, neurodegenerative diseases, and other areas of unmet medical need

http://www.genzyme.com/corp/structure/corp_home.asp

Solulink Developed a Crosslinking Chemistry Capable of Linking all Types of Molecules

2010-07-01T15:12:00.000-07:00

"Scientists at Solulink said they developed a crosslinking chemistry capable of linking all types of molecules, which retain their functionality when combined. The company’s Antibody-Oligonucleotide All-in-One conjugation kit links oligos of 20–60 base pairs in length to an antibody, creating an entity with dual functionality, according to the firm.

The technology can also be used to immobilize molecules on the surface of arrays, to link enzymes to other types of molecules, or to do dye labeling. The controlled linking process allows molecules to be joined in any desired ratio. The linker has a signature wavelength.

Solulink products include ChromaLink™ biotinylation kits, crosslinking and antibody labeling kits, and NanoLink™ and MagnaLink™ strepatvidin-coated magnetic beads in 0.8 µm and 2.8 µm sizes."

http://www.genengnews.com/gen-articles/personalizing-cancer-treatment/3322/?page=4

------------------------------------------------------

Easy to use
>80% efficient conjugations
Super stable conjugates-10x better stability than any other crosslinker
Can crosslink any biomolecules or surface
Quantifiable conjugates
Purification columns included

http://store.solulink.com/collections/crosslink

What Makes Solulink CrossLinking Technology Better?

Traceability	The bond formed with HyNic and 4FB absorbs at 354 nm with a molar extinction coefficient of 29,000.
Reproducibility	Biomolecule modification can be quantified for greater batch-to-batch reproducibility.
Linker Stability	Biomolecules modified with HyNic and 4FB have extended reaction stabilities.
Bond Stability	Bonds are stable to temperatures up to 94°C and a wide pH range of pH 2–11.
Specificity	Solulink crosslinking assures formation of heteroconjugates, with no formation of homoconjugates. Reactive linkers on modified biomolecules are inert and do not react with protein functional groups.

ACEA Biosciences: Cell Morphological Screening Can Lead to Better Understanding of Drug Prospects

2010-06-30T12:08:00.000-07:00

ACEA Biosciences designed a cell-based profiling approach for monitoring the effect of small molecule compounds based on their time-dependent cell response profiles. This approach allows continuous sampling of cellular responses to biologically active compounds. They tested many different compounds with similar activity and measured their time-dependent cell response profiles and found that ACEA can produce a predictable model with this technique. This technique can be used to investigate "off target" and off label effects of drugs already on the market or in testing. This test also can help determine better compounds to choose from that can be more effective, with less side-effects and needing less human testing to see preliminary results.

Increasing the predictability of drug toxicity and effectiveness can save lots to time and money. If you make a drug that effects the target but may kill the patient that research is wasted. If you make a drug that is safe but ineffective the drug will never get to market either. Finding ways to use existing predictable measurements to find the most effective and safest compounds is the best way to getting a successful drug to market.

"Multidimensional phenotypic profiling approaches including gene expression profiling, proteomic profiling, protein-fragment complementation profiling, high content microscopy-based profiling, and cell line cytotoxicity-based profiling have the capacity to measure both the interaction of compounds on intended targets and also to generate testable hypotheses concerning mechanism of action and off-target effects."

Adding all those factors into a database can produce clusters of similar acting compounds.

"To address this [expression levels, effective concentration and time] limitation, we have devised a live cell morphological profiling (measuring change in shape, structure, color or pattern) approach for dynamic monitoring of the effect of small molecule compounds that is based on impedance measurement of cells growing on microelectronic sensors integrated in wells of microtiter plates."

Microelectronic-based monitoring is the technique of measuring the cell's kinetic profile.

"We found that small molecule compounds with similar biological activity produced similar impedance-based time-dependent cell response profiles (TCRPs)."

[ACEA has] "designed a real-time cell electronic sensing (RT-CES; now known as xCELLigence RT-CA) system that uses microelectronic plates (E-Plates) integrated with gold microelectrode arrays on glass substrate in the bottom of the wells to measure cellular status in real time."

["ACER tested a] 2000 compound library consisting of FDA approved drugs (50%), natural products (29%), bioactive compounds (18%), and herbicides and insecticides (3%) were screened against A549 non-small lung cancer cells and PC3 prostate cancer cell lines using the RT-CES platform. These criteria not only allow for the identification of compounds with biological activity but also sufficiently distinguishable TCRPs to be used for clustering analysis."

"Closer examination of compounds in this category revealed another common underlying mechanistic feature, which is modulation of intracellular calcium levels or pathways within the cells either directly or indirectly."

Another common revelation of the TCRP analysis was discovering compounds interfering with DNA synthesis of cells causing toxic results.

When the test looked a calcium levels it was able to identify COX-2 inhibitors. COX-2 is a major enzyme involved in inflammation. During the TCRP test hey looked more into the effects of (Celebrex). Further studying of Celebrex using this test may lead toward finding modified versions of this drug with less side-effects.

Significance

The utility of the TCRP approach was demonstrated by identifying activities and “off-target effects” for certain drugs currently in use in the clinic and experimental compounds. The time resolution provided by the TCRP approach can be used in conjunction with phenotypic profiling approaches to obtain additional mechanistic data associated with small molecule compounds.

doi:10.1016/j.chembiol.2009.05.011

Volume 16, Issue 7

, 31 July 2009, Pages 712-723

BioLegend 206D Antibody used in FOXP3 Gene Study in Diabetic Patients

2010-06-28T12:23:00.000-07:00

"FOXP3 (forkhead box P3) is a gene involved in immune system responses. A member of the FOX protein family, FOXP3 appears to function as the master regulator in the development and function of regulatory T cells.^[1]

^{The induction or administration of Foxp3 positive T cells has, in animal studies, led to marked reductions in (autoimmune) disease severity in Type I Diabetics."}
http://en.wikipedia.org/wiki/FOXP3
-----------------------------------
"FoxP3 antibodies from eBioscience (236A/E7 and PCH101) and BioLegend (206D) were evaluated along with their respective methods and fix/perm reagents for preparation and staining of FoxP3 for flow cytometry.
Clone 206D from BioLegend yielded optimal staining and the fix/perm reagents from both eBioscience and BioLegend were comparable."

"We found that the clone 206D antibody (BioLegend) gave the most favorable staining of Tregs, based on FoxP3 level of expression in the CD25^high population. Additionally, we found that the cell fixation and permeablization reagents from eBioscience and BioLegend were comparable in detecting FoxP3⁺ positive cells in the CD25^high population."

Validated protocol for FoxP3 reveals increased expression in Type 1 diabetes patients. Cytometry Part B 2008; 00B: 000-000
-----------------------------------------
BioLegend clone in a recent study and found this clone to work well at identifying FoxP3⁺ cells

CD127 expression inversely correlates with FoxP3 and suppressive function of human CD4+ T reg cells. J Exp Med 2006; 203: 1701-1711.

------------------------------------------
"Type 1 diabetes (T1D) is a T-cell mediated autoimmune disease targeting the insulin-producing pancreatic β cells. Naturally occurring FOXP3⁺CD4⁺CD25^high regulatory T cells (T_regs) play an important role in dominant tolerance, suppressing autoreactive CD4⁺ effector T cell activity. Previously, in both recent-onset T1D patients and β cell antibody-positive at-risk individuals, we observed increased apoptosis and decreased function of polyclonal T_regs in the periphery. Our objective here was to elucidate the genes and signaling pathways triggering apoptosis in T_regsfrom T1D subjects."
http://www.plosone.org/article/info:doi/10.1371/journal.pone.0006527

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"To understand better how diabetogenic CD4⁺ T cells induce isletß-cell death and cause diabetes, a transfer modelof acute diabetes using the diabetogenic CD4⁺BDC2.5 T-cellclone was established. ...these resultsdemonstrate that activated macrophages are the key cells mediatingislet ß-cell death induced by activated CD4⁺ T cells."
http://ajp.amjpathol.org/cgi/content/abstract/169/6/2137

BioLegend's Homeobox Protein NANOG 1:1000 Used in Studying Prostate Tumor Cells

2010-06-27T10:42:00.000-07:00

"NANOG (pron. nanOg) is a transcription factor critically involved with self-renewal of undifferentiated embryonic stem cells. In humans, this protein is encoded by the NANOG gene.^[1]^[2]

^{Human NANOG protein is a 305 amino acid protein with a conserved homeodomain motif that is localized to the nuclear component of cells. The homeodomain region facilitates DNA binding.}

^{NANOG may be useful in the immunohistochemical diagnosis of tumors."}

^{http://en.wikipedia.org/wiki/Homeobox_protein_NANOG}
^{-----------------------------------------------------------------------------------}
^{"A homeobox is a DNA sequence found within genes that are involved in the regulation of patterns of development (morphogenesis) in animals, fungi and plants."}
^{http://en.wikipedia.org/wiki/Homeobox}
^{---------------------------------------------------------------}

^{Expression of Pluripotent Stem Cell Reprogramming Factors by Prostate Tumor Initiating Cells}
^{The Journal of Urology}

Volume 183, Issue 5

, May 2010, Pages 2045-2053

^{"representative results of 3 independent experiments show that RT-PCR identified OCT3/4, SOX2, Nanog, c-Myc andKlf4 expression in E-cadherin⁺ and E-cadherin^– cells isolated from DU145 and PC3 cells"}
-----------------------------------------

The Journal of Urology
Expression of Pluripotent Stem Cell Reprogramming Factors by
Prostate Tumor-Initiating Cells

PCR Primer specifics

PRIMER SEQUENCE

F5’-CCTCCTCCATGGATCTGCTTATTCA-3’
R5’-CAGGTCTTCACCTGTTTGTAGCTGAG-3’

Reference

Pal and Ravindran.
Cell Prolif 2006;
39:585-598.

http://www.urology.ufl.edu/JOU0510.pdf

Becton Dickinson Licenses real-time PCR technology from Exiqon

2010-06-25T13:17:00.000-07:00

The miRCURY LNA™ microRNA PCR system is a fast and easy way to accurately quantitate mature microRNAs by real-time PCR. The system combines the unique advantages of LNA™ technology and the well-known SYBR™ Green detection technology in a simple two-step procedure designed for total RNA samples.
http://www.exiqon.com/microrna-real-time-pcr
------------------------

Exiqon said this week that it has non-exclusively licensed its locked nucleic acid technology to Becton Dickinson for use in infectious disease diagnostics.

The licensing agreement marks the first time that a company other than Exiqon will use the LNA technology to develop diagnostic products, the company said.

In addition, the deal is part of a concerted effort by Exiqon over the last several months to partner with other companies to explore commercial applications of LNAs, around which the company has an extensive patent portfolio, CEO and President Lars Kongsbak told PCR Insider.

http://www.genomeweb.com/pcrsample-prep/exiqon-licenses-lna-tech-bd-use-pcr-based-infectious-disease-dxs

-----------------------------

What is LNA™?

Locked Nucleic Acid (LNA™) is a conformationally restricted nucleic acid analogue, in which the ribose ring is "locked" with a methylene bridge connecting the 2’-O atom and the 4’-C atom. LNA™ nucleotides containing the six common nucleobases (T, C, G, A, U and mC) can form base-pairs with their complementary nucleotides according to standard Watson-Crick base pairing rules.

Back to top

What are the unique properties of LNA™?

Incorporation of LNA™ monomers in one strand of a nucleic acid duplex will increase the melting temperature of the duplex with 2-8°C per LNA™ monomer. Thus, LNA™ vastly improves the thermal stability and specificity of duplexes formed with complementary DNA or RNA.
http://www.exiqon.com/ls/FAQ/faq%20lna%20lna.htm#1

Tioga Pharmaceuticals Starts Phase 3 for DIBS Drug Asimadoline

2010-06-24T09:42:00.000-07:00

SAN DIEGO, June 3 /PRNewswire/ -- Tioga Pharmaceuticals, Inc. announced today that the company has dosed its first subject in a Phase 3 clinical trial
to evaluate asimadoline for the treatment of patients with diarrhea-predominant irritable bowel syndrome
(DIBS). The trial, referred to as ASMP3001, is the first of two Phase 3 trials being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for U.S. registration. This first trial will be conducted at 120 sites in the U.S.

http://www.thefreelibrary.com/Tioga+Pharmaceuticals+Begins+Phase+3+Trial+of+Asimadoline+in...-a0227929286
-------------------
Tioga Pharmaceuticals is focused on the development of novel therapies for the treatment of gastrointestinal diseases. Tioga was founded in 2005 by Forward Ventures and raised $24 million in its Series A financing, with New Leaf Venture Partners and BB Biotech Ventures also investing in the round.

Tioga's lead compound, asimadoline, is currently in clinical development for the treatment of irritable bowel syndrome (IBS). This disorder represents a large unmet medical need and substantial market opportunity.

Asimadoline is a proprietary small molecule therapeutic initially discovered and developed by Merck KGaA of Darmstadt, Germany to treat peripheral pain. Tioga has acquired all rights to asimadoline from Merck. The compound has been tested in over 1,100 subjects and has demonstrated a promising safety profile.Asimadoline has shown encouraging clinical efficacy for the treatment of IBS and has the potential for treating other gastrointestinal diseases.
http://www.tiogapharma.com/index.html

-------------------------------------------
Asimadoline, a κ-Opioid Agonist, and Visceral Sensation

Neurogastroenterol Motil. Author manuscript; available in PMC 2009 June 17.

Published in final edited form as:

Neurogastroenterol Motil. 2008 September; 20(9): 971–979.

doi: 10.1111/j.1365-2982.2008.01183.x.

Post-hoc analyses suggest asimadoline was effective in mixed IBS. In a 12-week study in 596 patients, chronic treatment with asimadoline, 0.5 mg and 1.0 mg, was associated with adequate relief of pain and discomfort, improvement in pain score and number of pain free days in patients with IBS-D

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2698012/?tool=pubmed

Neurocrine Biosciences Collaboration with Boehringer Ingelheim on Type II Diabetes Drug

2010-06-17T12:42:00.000-07:00

Neurocrine Biosciences, Inc. (NBIX), Boehringer Ingelheim Corporation to Develop Diabetes Drug; Neurocrine to Get $10 Million Upfront; up to $225 Million in Milestone Payments
6/17/2010

SAN DIEGO, June 17 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq:NBIX - News) announced today that they have established a worldwide collaboration with Boehringer Ingelheim to research and develop small molecule GPR119 agonists for the treatment of Type II diabetes and other indications. The companies will work jointly to identify and advance candidates into pre-clinical development. Boehringer Ingelheim is responsible for the global development and commercialization of potential GPR119 agonist products.

Under the terms of the collaboration agreement, Neurocrine Biosciences will receive a $10 million upfront payment, research funding to support discovery efforts and is eligible to receive up to $225 million in milestone payments based on the achievement of development, regulatory and commercial goals as well as royalty payments on any future product sales. Further financial details were not disclosed.

"We are looking forward to working with a high-quality partner who shares our commitment to thorough science and our collaborative culture. We are excited to bring our technology platform 'SiNERG™,' a suite of assays and assay systems that address parameters such as residence time, kinetics, allosteric interactions and ligand-biased intracellular signaling pathways, coupled with our integrated chemical synthetic, purification and analytical methodologies to this collaboration," said Dr. Dimitri E. Grigoriadis, Vice President Research at Neurocrine. "Combining Boehringer Ingelheim's research and development expertise in metabolic disorders with Neurocrine's unique capabilities in small molecule discovery for GPCRs provides a strong platform for development of new therapies for Type II diabetes."

About GPR119 Agonists

GPR119 is a G-protein coupled receptor (GPCR) that has been implicated as a novel target for the treatment of Type II diabetes. The activation of GPR119 receptors located in the digestive system stimulates incretins, resulting in increased insulin production, while activation of GPR119 receptors located on pancreatic islet beta cells also stimulates insulin secretion.

http://www.biospace.com/news_story.aspx?StoryID=184482&full=1&utm_source=feedburner&utm_medium=feed&utm_campaign=Feed:+SDBNBlogNews+(SDBN+Blog,+News)

------------------------------

"GPR119 is expressed predominantly in the pancreas and gastrointestinal tract in rodents and humans, as well as in thebrain in rodents.^[5] Activation of the receptor has been shown to cause a reduction in food intake and body weight gain in rats.^[5] GPR119 has also been shown to regulate incretin and insulin hormone secretion.^[6]^[7]^[8] As a result, new drugs acting on the receptor have been suggested as novel treatments for obesity and diabetes.^[5]^[7]^[9]"

^{http://en.wikipedia.org/wiki/GPR119}

Amylin Pharmaceuticals Co-developed Type II Diabetes Candidate Moving Forward on Approval

2010-06-17T10:49:00.000-07:00

"Recently Alkermes Inc. (ALKS), Amylin Pharmaceuticals Inc. (AMLN) and Eli Lilly & Co. (LLY), the co-developers of type II diabetes candidate Bydureon (exenatide once weekly), announced mixed results from one of several studies conducted to evaluate the superiority of the candidate over other type II diabetes therapies."

http://seekingalpha.com/article/210540-mixed-results-for-jointly-developed-diabetes-treatment?source=email

Bydureon's blood sugar lowering performance and weight loss was similar to the existing proved drug metformin. Bydureon did out perform Januvia, the other drug compared in the study. Bydureon is a once weekly drug vs. Metformin the once per meal or once per night drug.

---------------------

FDA assigns BYDUREON new PDUFA action date of October 22, 2010

Prescription Drug User Fee Act (PDUFA) action date of October 22, 2010

"If approved, BYDUREON will be the first once-weekly treatment for type 2 diabetes, and we are committed to making this important therapeutic option available to patients as soon as possible," said Orville G. Kolterman, M.D., senior vice president of research and development, Amylin Pharmaceuticals. "We will continue to work closely with the agency through this final stage of the review process."

http://www.news-medical.net/news/20100506/FDA-assigns-BYDUREON-new-PDUFA-action-date-of-October-22-2010.aspx

-----------------------------------

June 15, 2010

Study Design

The 26-week, double-blind, randomized, four-arm parallel study enrolled 820 patients who were not achieving adequate A1C control on diet and exercise. Patients had an average type 2 diabetes diagnosis of two to three years. The patients were randomized as follows: BYDUREON (2 mg, once per week) (n=248); metformin (dose escalated up to 2,500 mg/day) (n=246); Actos (dose escalated up to 45 mg/day) (n=163); and Januvia (100 mg/day) (n=163). The primary endpoint was reduction in A1C, while secondary endpoints included change in body weight along with other parameters of glucose control, cardiovascular health and patient-reported outcomes.

http://phx.corporate-ir.net/phoenix.zhtml?c=101911&p=irol-newsArticle&ID=1438147

Beckman Coulter will market CaridianBCT cell therapy products

2010-06-16T20:21:00.000-07:00

ORANGE COUNTY, Calif. (June 16, 2010) – Beckman Coulter, Inc., has entered into a strategic alliance with CaridianBCT, under the terms of which Beckman Coulter will market CaridianBCT cell therapy products in specific, targeted markets.
CaridianBCT and Beckman Coulter will launch CaridianBCT's Quantum Cell Expansion System, a closed system that automates the cell expansion process, along with marketing CaridianBCT’s COBE* 2991 Cell Processor, a system that washes and concentrates cell populations, and the Elutra* Cell Separation System, which purifies cell populations via elutriation.
Adding the Quantum, Elutra and COBE 2991 systems to the Beckman Coulter line of products for cell sorting, cellular analysis and characterization will enable the company to provide pharmaceutical companies, research institutes and clinical trial organizations with a full line of cellular discovery systems.
http://www.biosciencetechnology.com/News/Feeds/2010/06/sections-supplier-news-beckman-coulter-to-distribute-caridianbct-cell-the/
-------------------------------------------------------------------------------------------------------------------------------
NIH Clinical Center Testing Automated Cell Expansion System
The ease and security of automation is coming to bone marrow stromal cell expansion in a new machine in the National Institutes of Health Clinical Center's Department of Transfusion Medicine. Reducing the current manual method guarantees less contamination and frees staff time for other procedures.
In the collaborative effort, the department is using a prototype of CardianBCT’s Quantum Cell Expansion System to reproduce human bone marrow stromal cells in an automated, sealed environment. The collaboration is part of the Trans-NIH Bone Marrow Stromal Cell Transplantation Center, created in 2008 to facilitate the use of clinical-grade bone marrow stromal cells prepared using procedures known to maintain their biological activities and to assist investigators in the preparation of protocols that utilize such cells. The trans-NIH group is co-coordinated by Dr. Pamela Robey of the National Institute of Dental and Craniofacial Research and Dr. Harvey G. Klein, chief of transfusion medicine at the Clinical Center.
http://www.nih.gov/news/health/sep2009/cc-25.htm
-------------------------------------------------------

The COBE 2991 Cell Processor provides operational reliability using automation for control and consistency:

Variable spin times and speeds allow separation of components through centrifugation
The agitate mode washes desired cell components with a choice of solutions
Fluids or cells are expressed by the action of hydraulic fluid against a flexible membrane

http://www.caridianbct.com/location/north-america/products-and-services/Pages/cobe-2991-cell-processor.aspx

BD Biosciences to Fund $100,000 in Stem Cell Research Grants

2010-06-16T19:58:00.000-07:00

New Stem Cell Grants Bring Research Grant Program Total to $240,000, Offering Additional Support for Innovative Life Sciences Research

SAN DIEGO, June 16 /PRNewswire/ -- BD Biosciences, a segment of BD (Becton, Dickinson and Company), announced today a further expansion of its Research Grant program, adding $100,000 worth of reagents, cell culture tools and labware to support promising stem cell research.

"Even though the peak of the economic crisis appears to already have been reached, life scientists in the United States are still in desperate need for resources to keep their research projects alive," said Robert Balderas, Vice President of Biological Sciences, BD Biosciences. "BD Biosciences is proud to do its part to help advance some of the most promising stem cell and immunology research that could one day help cure or prevent disease."

http://www.prnewswire.com/news-releases/bd-biosciences-to-fund-100000-in-stem-cell-research-grants-96479064.html

----------------------------------------------------------

Arena Pharmaceuticals Gets $35.5 Million in Funding

2010-06-16T19:44:00.000-07:00

Arena Pharmaceuticals (NASDAQ: ARNA), the San Diego-based developer of an experimental obesity drug, said today it has raised $35.5 million through an equity financing from Deerfield Management. Arena agreed to sell 11 million shares to Deerfield at $3.23 apiece

Luke Timmerman 6/3/10

http://www.xconomy.com/san-diego/2010/06/03/arena-adds-35m-from-deerfield/

------------------------------------------------

Lorcaserin for Weight Management

Our most advanced drug candidate, lorcaserin, is for weight management, including weight loss and maintenance of weight loss. In December 2009, after completing a pivotal Phase 3 clinical trial program, we submitted a New Drug Application, or NDA, for lorcaserin to the FDA. The NDA submission is based on a data package from lorcaserin’s clinical development program that includes 18 clinical trials totaling 8,576 patients. In February 2010, the FDA accepted our lorcaserin NDA for filing and assigned a Prescription Drug User Fee Act, or PDUFA, date of October 22, 2010, for the review of our application.
The lorcaserin Phase 3 pivotal program consists of the BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management) and BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management) trials, which evaluated 7,190 patients for up to two years. In addition to the pivotal program, we are evaluating the safety and efficacy of lorcaserin for weight management in obese and overweight patients with type 2 diabetes in our Phase 3 BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus) trial. We plan to file the results of BLOOM-DM as a supplement to the NDA.

About Lorcaserin
Lorcaserin is a novel single agent that represents the first in a new class of selective serotonin 2C receptor agonists. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area involved in the control of appetite and metabolism. Stimulation of this receptor is strongly associated with feeding behavior and satiety. We have patents that cover lorcaserin in the U.S. and other jurisdictions, which in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity we might obtain.

http://www.arenapharm.com/wt/page/lho.html
------------------------------------------------------------------

Deerfield Management Company L.P.

COMPANY OVERVIEW

Deerfield Management Company L.P. is a privately owned hedge fund sponsor. The firm invests the public equity markets of the United States. It primarily invests in the healthcare companies. Deerfield Management Company was founded in 1994 and is based in the New York, New York.

RECENT PRIVATE COMPANIES TRANSACTIONS

Type Date	Target
Private Placement June 7, 2010	Hana Biosciences, Inc.
Private Placement June 2, 2010	Arena Pharmaceuticals, Inc.
Private Placement June 2, 2010	Exelixis, Inc. http://investing.businessweek.com/businessweek/research/stocks/private/snapshot.asp?privcapId=3751585

FDA: Genetic Tests are Medical Devices and are Regulated as Such

2010-06-16T10:53:00.000-07:00

The FDA will regulate certain types of diagnostic tests the same way the agency monitors medical devices. Genetic testing companies deCODE Genetics, Illumina, Knome, Navigenics, and 23andMe all received letters from regulators last week informing them that, since their tests make health claims, they must be submitted for approval. Genetic test makers have thus far operated with very little agency oversight.

Read more: FDA: Genetic tests are medical devices - FierceMedicalDevices http://www.fiercemedicaldevices.com/story/fda-genetic-tests-are-medical-devices/2010-06-16#ixzz0r2VRVZ2J
Subscribe: http://www.fiercemedicaldevices.com/signup?sourceform=Viral-Tynt-FierceMedicalDevices-FierceMedicalDevices

-------------------------------------------------
RE: Illumina® Infinium HumanHap550 array
Dear Mr. Flatley:
The United States Food and Drug Administration (FDA) has determined that your firm manufactures the Illumina® Infinium HumanHap550 array used by deCODE Genetics and 23andMe to provide genetic information to their customers. The Illumina® Infinium HumanHap550 array is a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h) because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.

In 1976, Congress enacted the Medical Device Amendments (MDA), which amended the Act to provide for premarket regulation of medical devices intended for use in humans. This premarket review of medical devices enables FDA to protect the public from medical products that may pose an unreasonable risk of harm. It is important that they be analytically and clinically accurate so that individuals are not misled by incorrect test results or unsupported clinical interpretations. Premarket review allows for an independent and unbiased assessment of a diagnostic test's ability to generate test results that can reliably be used to support good healthcare decisions.

Although Illumina, Inc. has received FDA clearance or approval for several of its devices, we note that the Illumina® Infinium HumanHap550 array is not one of them and is labeled "For Research Use Only". Yet Illumina is knowingly providing the HumanHap550 array to 23andMe and deCODE Genetics for clinical diagnostic use without FDA clearance or approval.

During a meeting between Illumina and FDA on July 31, 2009, you stated that 23andMe and deCODE genetics both order Illumina arrays for use in their personal genome diagnostic tests. For example, the 23andMe Personal Genome Service™ uses both the Illumina® Infinium HumanHap550 array and a custom array for its Personal Genome Service™. The 23andMe Personal Genome Service™ and the deCODEme Genome Scan both provide an estimate of an individual's risk for various diseases or conditions based on genotypic data.

Mr. Jay Flatley Illumina, Inc

We are not aware that you have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) ofthe Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). In addition, we are not aware that you have notified the agency of your intent to introduce the device into commercial distribution, as required by section 51 O(k) ofthe Act, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by section S10(k) ofthe Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. 21 C.F.R. 807.81(b).

You should take prompt action to respond to this letter. If you would like to meet with us to discuss whether there are tests you are promoting that do not require review by FDA and what information you would need to submit in order for your product to be legally marketed for the other uses, let us know and we will schedule a meeting with you. Please direct your questions and response to: James L. Woods, Food and Drug Administration, 10903 New Hampshire Avenue, W066-5688, Silver Spring, MD 20993 or facsimile at (301) 8478514.
General information on obtaining approval or clearance for devices is described on the Internet athttp://www.fda.gov/cdrhldevadvice/3122.html.
This letter pertains only to the issue of premarket review for your device and does not necessarily address other obligations you have under the law. FDA is available to discuss other obligations for medical device manufacturers with you.

Sincerely yours,
Alberto GutIerrez, Ph.D. Office ofIn Vitro Diagnostic Device Evaluation and Safety Center for Device and Radiological Health

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm111104.htm
--------------------------------

May 10, 2010

James Plante
Founder and CEO
Pathway Genomics Corporation
4045 Sorrento Valley Blvd.
San Diego, CA 92121

Dear Mr. Plante:

It has come to our attention that you are currently marketing the Pathway Genomics Genetic Health Report, a home-use saliva collection kit, intended to report customary and personal genetic health disposition results for more than 70 health conditions, including pharmacogenetics (prescription medication response), propensity for complex disease, and carrier status (pre-pregnancy health) information from which one can modify their health regime to live a healthier, longer life. The Genetic Health Report appears to meet the definition of a device as that term is defined in section 201(h) of the Federal Food Drug and Cosmetic Act.

We have conducted a review of our files, and have been unable to identify any Food and Drug Administration (FDA) clearance or approval number for the Genetic Health Report. We request that you provide us with the FDA clearance or approval number for the Genetic Health Report. If you do not believe that you are required to obtain FDA clearance or approval for the Genetic Health Report, please provide us with the basis for that determination.

The requested information should be submitted to:

James L. Woods
Deputy Director, Patient Safety and Product Quality
Office of In Vitro Diagnostic Device Evaluation and Safety
10903 New Hampshire Avenue
White Oak 66
Silver Spring, MD 20993

We would appreciate a response within 15 days from the date of this letter. If you have any questions relating to this matter, please feel free to call Cecily Jones at 301-796-6172, or access our web site at http://www.fda.gov for general information relating to FDA's device requirements.

Sincerely yours,

James Woods
Deputy Director
Patient Safety and Product Quality
Office of In Vitro Diagnostic Device Evaluation and Safety
Center for Devices and Radiological Health

Vet-Stem Awarded Contract to study Stem Cell Biology in Marine Mammals

2010-06-15T01:20:00.000-07:00

POWAY, Calif., March 18 /PRNewswire/ -- Vet-Stem, Inc. is pleased to announce that the U.S. Navy, Office of Naval Research, has awarded a contract to Vet-Stem to engage in a collaborative study of stem cell biology in marine mammals. The contract was awarded on August 3, 2009. The company will apply its considerable expertise in isolating and working with adipose-derived stem cells (ASCs) from animals, including horses, dogs, cats and more exotic species.

The contract will cover research to be conducted at Vet-Stem's facility in Poway, California, on ASCs in marine mammals. Vet-Stem currently is engaged in a preliminary evaluation of ASCs from marine mammals and has demonstrated that marine mammal adipose-derived cells can be grown in culture conditions similar to ASCs from other mammals, like horses and dogs.

http://www.prnewswire.com/news-releases/vet-stem-announces-office-of-naval-research-contract-88451902.html
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The following news items have been accumulated from owners and veterinarians from various news agencies. Vet-Stem wants you to remember that like with other treatment options, not all pets respond to Vet-Stem cell therapy. Approximately 25% of dogs treated for arthritis had no improvement in quality of life according to voluntary owner surveys.

Pet owners should discuss appropriateness of treatment for their pet including potential complications of surgery, potential outcomes, a comprehensive treatment plan and associated costs with their veterinarian prior to treatment. A checklist of points to consider can be found here to take to your veterinarian.

http://www.vet-stem.com/news/

Sequenom Executive Pleads Guilty Misleading about Effectiveness of Diagnostic Test

2010-06-15T00:52:00.000-07:00

Sequenom Executive Pleads Guilty, Banned from Leading Any Public Company (for Misleading Investors About the Performance of a Diagnostic Test?)

Dragon admitted to making false claims to investors and analysts about the effectiveness of the San Diego-based company’s test as well as attempting to 'inflate and sustain' the price of Sequenom’s shares, said Laura E. Duffy, the U.S. Attorney for the Southern District of California in San Diego, in a statement. Dragon said in a court appearance before U.S. Magistrate Judge Barbara Major that she and others manipulated data to make the Down syndrome test appear more accurate than it was, Duffy said.

http://hcrenewal.blogspot.com/2010/06/sequenom-executive-pleads-guilty-banned.html

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Sequenom is committed to improving healthcare through revolutionary genetic analysis solutions.

Sequenom develops innovative technology, products and diagnostic tests that target and serve discovery and clinical research, and molecular diagnostics markets.

The company's proprietary MassARRAY® system is a high-performance DNA analysis platform that efficiently and precisely measures the amount of genetic target material and variations therein. The system is able to deliver reliable and specific data from complex biological samples and from genetic target material that is only available in trace amounts. The company has exclusively licensed intellectual property rights for the development and commercialization of noninvasive prenatal genetic tests for use with the MassARRAY system and other platforms.

http://www.sequenom.com/About-Us/Overview

Althea Technologies Helping Altus Pharmaceuticals Capitalize on Growth Hormone (GH) Market

2010-06-15T00:32:00.000-07:00

Growth Hormone Deficiency (GHD) - Pipeline Analysis and Market Forecasts to 2016

// 15.06.2010

GlobalData, the industry analysis specialist’s new report, “Growth Hormone (GH) Deficiency - Drug Pipeline Analysis and Market Forecasts to 2016” is an essential source of information and analysis on the global growth hormone deficiency market. The report identifies the key trends shaping and driving the global growth hormone deficiency market. The report also provides insight on the prevalent competitive landscape and the emerging players expected to bring significant shift in the market positioning of the existing market leaders. Most importantly, the report provides valuable insight on the pipeline products within the global growth hormone deficiency sector. This report is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by GlobalData’s team of industry experts.

The GHD Therapeutics Market is Forecast to Grow Until 2016

The global Growth Hormone Deficiency (GHD) therapeutics market was worth $2.2 billion in 2009. The market is expected to grow by 13.4% during the next seven years to reach $5.4 billion by 2016. The GHD market has been well served by synthetic Growth Hormone (GH), GH regulators and GH secretagogues. The major marketed products for GHD include Genotropin, Humatrope, Nutropin, Saizen and Norditropin. These are indicated for the treatment of GHD in adults and children and have an efficacy of about 80%, but are lacking in safety. The treatment of GHD in adults seems ineffective through these options. Companies are now focusing on adult GHD, which will enable them to reap revenues from this growing market. The primary focus would be to provide safer and more efficacious products with improved formulations to reduce the frequency of administration. LG Life Sciences, Althea Technologies, Ambrx Inc., Novo Nordisk and Ipsen are believed to be working on the same method of meeting the unmet need in the market. The global GHD market is heading towards a phase of continuous growth as more products are expected to join the market by 2016.

http://marketpublishers.com/lists/7349/news.html

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8.22.2006 Althea Technologies to Manufacture Altus Pharmaceutical's ALTU-238 Human Growth Hormone for Phase III Studies

SAN DIEGO – August 22, 2006 -- Althea Technologies, Inc., a leading provider of innovative technologies and services for pharmaceutical development and manufacturing, announced today that it has been awarded a contract from Altus Pharmaceuticals Inc. to produce its ALTU-238 product candidate, a crystallized formulation of Human Growth Hormone (HGH) that is designed to be administered once-weekly through a fine gauge needle for the treatment of HGH disorders. Altus Pharmaceuticals Inc. (NASDAQ: ALTU), based in Cambridge, MA, is a biopharmaceutical company focused on the development and commercialization of oral and injectable protein therapeutics for patients with gastrointestinal and metabolic disorders.

“Althea Technologies is a seasoned CMO with significant experience in the manufacture of recombinant proteins,” commented Sheldon Berkle, President and CEO of Altus. “We look forward to working together through technology transfer and the installation and qualification of the key equipment necessary for the production of ALTU-238. We feel confident in their ability to manufacture reliable quantities of ALTU-238 for our planned Phase III clinical trials that meet our high standards of quality and patient safety.”

Althea Technologies will manufacture the Phase III clinical trial material of ALTU-238 human growth hormone in its newly expanded cGMP manufacturing facilities at the company’s San Diego, California campus.

President and Co-CEO of Althea, Dr. Magda Marquet, added, “We are pleased that Altus Pharmaceuticals selected Althea Technologies to manufacture their innovative ALTU-238 product. As a leader in providing highly technical drug development services to the industry, we are committed to working with Altus to effectively and efficiently manufacture ALTU-238.”

---------------------------

ALTU-238 is a long acting crystalline formulation of recombinant human growth hormone (rhGH) that is being developed for the treatment of growth hormone deficiency in adults and children. ALTU-238 is designed to require fewer injections than the currently available formulations of rhGH.

http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00297713

FDA Putting Foot Down on Genetic Testing Kit Manufactures Pathway and Illumnia and others

2010-06-14T09:46:00.000-07:00

The Food and Drug Administration has put five genetic test makers on notice that they must get federal approval before marketing their products for use by consumers.

23andMe, deCODE Genetics, Illumina, Navigenics and Knome and Pathway Genomics have NOT submitted their tests for approval, according to the FDA.

The FDA suggests not enough data to prove these test accurate enough for their liking.

http://www.mercurynews.com/business/ci_15278011?nclick_check=1

-----------------------

How accurate are Pathway's personal genetic reports?

Pathway's genetic reports are accurate. Our in-house laboratory has met the high standards set by federal Clinical Laboratory Improvement Amendments (CLIA) regulations and state licensure requirements, thereby assuring you of high quality results.

Unlike other laboratories that outsource the actual performance of the laboratory tests and only handle the interpretations and the reporting of the results, we handle the testing, interpretation and reporting from beginning to end. This allows Pathway better control over the research, testing, pricing and security.

http://www.pathway.com/about-us

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Illumina is leading the way in the genetics community with technologies that translate the genome (DNA) into something people can begin to read and interpret. The vision of personalized medicine—the right drug for the right patient at the right time—is in large part possible because of the technology developed by Illumina.

Illumina's technology is found in top research institutions around the world, and is now available to you through the Illumina Individual Genome Sequencing (IGS) service. This service provides you with the genetic information that, together with the advice of your doctor, can be leveraged to make informed decisions related to your health and well being.

http://www.everygenome.com/about_us/technology.ilmn

PURE Bioscience Receives Patent for Anhydrous Silver Dihydrogen Citrate Technology

2010-06-14T01:06:00.000-07:00

SAN DIEGO--(BUSINESS WIRE)--PURE Bioscience (NASDAQ:PURE - News) today announced that the United States Patent and Trademark Office issued patent number 7,732,486, which covers PURE’s anhydrous silver dihydrogen citrate technology.

http://finance.yahoo.com/news/PURE-Bioscience-Granted-bw-1569132321.html?x=0&.v=1
----------------

PURE Biosciences has patents in approximately 70 countries and is dedicated to providing solutions for world healthcare problems such as staph infection. The company’s technology is meant to be high efficacy and low toxicity, engaging in the world’s green movement.

http://www.worldmarketmedia.com/779/section.aspx/1797/post/pure-bioscience-recieves-7th-patent-nasdaqpure

Trius Therapeutics Redesigning Torezolid Phosphate Phase 3 Trial

2010-06-14T00:54:00.000-07:00

"Trius Therapeutics believes that the draft guidance will provide greater clarity to the process of finalizing the design of its Phase 3 trials. As a result of the new guidance, the Company has temporarily delayed its IPO until it can modify the protocol for its Phase 3 trial."

http://www.medicalnewstoday.com/articles/190331.php
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Torezolid phosphate (TR-701) is a second generation oxazolidinone being developed for the treatment of serious gram-positive infections, including those caused by MRSA. Torezolid phosphate (TR-701) is the second generation oxazolidinone furthest advanced in clinical development for the treatment of such infections. Torezolid phosphate (TR-701) is a novel prodrug antibiotic that is cleaved in the blood stream to the active compound, torezolid (TR-700).
http://www.triusrx.com/trius-therapeutics-torezolid-profile.php
-----------------------------
Methicillin-resistant Staphylococcus aureus (MRSA) is a bacterial infection that is highly resistant to some antibiotics.

More serious MRSA infections, especially HA-MRSA infections, are becoming increasingly difficult to treat. Antibiotics that may still work include:

Clindamycin
Daptomycin
Doxycycline
Linezolid (Zyvox)
Minocycline
Tetracycline
Trimethoprim-sulfamethoxazole (Bactrim, Bactrim DS, Septra, Septra DS)
Vancomycin (Vancocin, Vancoled)

https://health.google.com/health/ref/MRSA

----------------------------------------
6310 Nancy Ridge Drive
Suite 101
San Diego, CA 92121

Genzyme Fight with Investor Carl Icahn Over

2010-06-10T10:15:00.000-07:00

(Reuters) - Activist investor Carl Icahn has abandoned his proxy fight at Genzyme Corp (GENZ.O) in return for the biotechnology company's acceptance of two of his representatives to its board.

The agreement, announced on Wednesday, comes a week before the company's annual meeting on June 16.

Icahn had nominated himself and three allies to Genzyme's board after a manufacturing crisis lead to shortages of two of its life-saving drugs.

Genzyme has agreed to appoint two Icahn representatives -- Dr. Steven Burakoff and Dr. Eric Ende -- and in return Icahn will withdraw his slate and vote his shares in favor of the company's nominees.

"I think overall this is a positive," said Michael Obuchowski, chief investment officer at First Empire Asset Management, which owns Genzyme's shares and oversees nearly $4 billion in assets. "It avoids a continuing confrontation with Icahn and provides more oversight over the direction the company takes."

http://www.reuters.com/article/idUSTRE6583DR20100609

---------------------------------------------

FDA Delays Genzyme's Lumizyme, Manufacturing Problems Blamed

Genzymeannounced that the FDA is delaying final approval of the company’s application to market Lumizyme(alglucosidase alfa) for the treatment of Pompe disease. Not unexpected, given FDA regulators had sent out a memo last Friday warning healthcare providers that enzyme replacement drugs made at the Allston Landing plant might be contaminated with foreign particles, including stainless steel fragments, non-latex rubber, and fiber-like materials. Given production had previously been transitioned to a larger scale facility in Belgium, regulators’ hesitancy speaks loudly to ongoing concerns about the quality control of Genzyme’s “brewing” processes.

http://industry.bnet.com/pharma/10005372/a-cure-for-genzymes-pompe-disease-treatment-ceo-termeers-ouster/

Illumina Slashes Cost of Gene Sequencing

2010-06-09T19:04:00.000-07:00

The cost of getting your genome sequenced continues to drop. San Diego’s Illumina has lowered the cost of its individual sequencing service to $19,500 from $48,000.

The company is offering a discounted price of $9,500 for people with serious medical conditions who could potentially benefit from having their genomes decoded.

http://www.xconomy.com/san-diego/2010/06/09/illumina-slashes-cost-of-individual-genome-sequencing-service/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed:+Xconomy_San_Diego_Life_Sciences+(Xconomy+San+Diego+-+Life+Sciences)

-----------------------------------------------

Sequencing / DNA Sequencing

The Genome Analyzer system's powerful combination of read-length and paired-end flexibility enables the broadest range of genomic sequencing applications. Illumina's robust sequencing chemistry supports a wide range of read lengths, allowing researchers to tailor each run to meet their needs.

http://www.illumina.com/applications.ilmn#dna_sequencing

-------------------------------------

SNP Genotyping and CNV Analysis / SNP Discovery and Structural Variation Analysis

Single nucleotide polymorphisms (SNPs) and structural variants are at the root of genetic variation among individuals and populations. This variation influences how individuals differ in their risk of disease and their response to therapeutic treatments. SNPs and structural variants are discovered within the genome by comparing multiple genomic sequences from a diverse sample set of individuals. Illumina's industry-leading sequencing technology provides the sample throughput level and high-quality data required for accurate SNP discovery and structural variation analysis studies.

http://www.illumina.com/applications.ilmn#dna_sequencing

NexGen Biomedical, Inc. is offering its patented RNAi platform technology for sale

2010-06-07T12:48:00.000-07:00

NexGen's RNAi / PSR technology is exceptionally well suited for dermal and pulmonary indications requiring Antiproliferative, Anti-inflammatory, or Antiviral Activity.

While siRNA technology is well suited for disease conditions that involve hyperactive or inappropriate expression of a single protein, NexGen's RNAi / PSR technology is better suited for conditions that involve hyperactive synthesis of a broad spectrum of proteins, such as cell hyperproliferation, inflammation, or viral infection. While siRNA requires stabilizing and delvery technology, RNAi / PSR does not require any stabilization or delivery technology, and can be delivered exactly where needed by topical application, inhalation or transdermal delivery.

Richard Lepidi

http://www.linkedin.com/groupAnswers?viewQuestionAndAnswers=&discussionID=21747281&gid=1529007&trk=EML_anet_qa_ttle-d7hOon0JumNFomgJt7dBpSBA

Life Technologies Corporation Creating Genomic Cancer Care Alliance

2010-06-04T14:07:00.000-07:00

CARLSBAD, Calif.--(BUSINESS WIRE)--Life Technologies Corporation (NASDAQ: LIFE) today announced the creation of the Genomic Cancer Care Alliance to help people battling cancer gain access to treatment options found through analysis of their genomic information. Founding partners include Fox Chase Cancer Center, Scripps Genomic Medicine, and the Translational Genomics Research Institute (TGen).The announcement came during the Consumer Genetics Conference being held June 2-4 in Boston.

The Alliance will launch a pilot study aimed at determining whether whole-genome sequencing can better guide treatment decisions across a number of difficult-to-treat cancers. US Oncology, Inc., the nation’s leading integrated oncology company, is expected to serve as the contract research and site management organization for the study

As currently envisioned, patients enrolled in the study will have both tumor and normal tissue sequenced by TGen, Scripps, and other organizations, using Life Technologies’ Applied Biosystems SOLiD™ System to identify mutations.

.http://www.businesswire.com/portal/site/biospace/permalink/?ndmViewId=news_view&newsId=20100603006763&newsLang=en

------------------------

The SOLiD™ System is a highly accurate, massively parallel next-generation sequencing platform that supports a wide range of applications. The flexibility of two independent flow cells and multiplexing capability allow you to conduct multiple experiments in a single run. With unparalleled throughput and greater than 99.94% basecalling accuracy, the SOLiD™ System enables you to complete large-scale sequencing and tag experiments more cost effectively than previously possible.

http://www.appliedbiosystems.com/absite/us/en/home/applications-technologies/solid-next-generation-sequencing.html

--------------------

Fox Chase Cancer Center RANKED #20 [Cancer Score Card] by US News and World Report

http://health.usnews.com/best-hospitals/fox-chase-cancer-center-american-oncologic-hospital-6231660/cancer

-----------------

Scripps Genomic Medicine

To bridge the gap between genomic discovery, translation and treatment of disease, Scripps Health invested millions to establish the Scripps Translational Science Institute (STSI) in 2007, which includes the Scripps Genomic Medicine program. Since cancer accounts for one in four deaths annually in the U.S. and cardiovascular disease is the nation's leading killer, much of our research is influenced to improve care and find cures for these particular devastating diseases. Eric J. Topol, MD, one of the premier cardiologists and physician/scientists in the world was recruited to lead the academic research programs. Dr. Topol was recently named a "Doctor of the Decade" by the Institute for Scientific Information for being one of the top 10 most cited researchers in medicine.

http://www.stsiweb.org/index.php/support/scripps_genomic_medicine

---------------------------

TGen

TGen is on the cutting edge of translational research where investigators are able to unravel the genetic components of common and complex diseases. Working with collaborators in the scientific and medical communities, TGen believes it can make a substantial contribution to the efficiency and effectiveness of the translational process. TGen's vision is of a world where an understanding of genomic variation can be rapidly translated to the diagnosis and treatment of disease in a manner tailored to individual patients

http://www.tgen.org/about/index.cfm?pageid=1

------------------------

US Oncology is the nation’s premier oncology services company, increasing patient access to safe, high-quality cancer care. Working closely with physicians, manufacturers, and payers, we develop innovative new approaches to confronting cancer, increasing the effectiveness of care, and ensuring a better patient experience.

http://www.usoncology.com/

---------------------------------

5791 Van Allen Way

Carlsbad, California 92008 USA

P (760) 603-7200

F (760) 602-6500

www.lifetechnologies.com

Life Technologies to Build a Research Center in Germany

2010-06-03T08:00:00.000-07:00

CARLSBAD, CALIF.

Biotechnology company Life Technologies Corp. said Wednesday it is collaborating with the German Cancer Research Center to create a national sequencing center.

The facility will be partially funded by the German Federal Ministry of Education and Research.

http://www.businessweek.com/ap/financialnews/D9G3CM1O4.htm

------------

The center will operate 10 SOLiD(TM) 4 hq systems acquired by DKFZ and will initially sequence 1000 whole human cancer genomes for Germany's national contribution to the International Cancer Genome Consortium (ICGC). The facility will be partially funded by the German Federal Ministry of Education and Research.

"Our aim is to understand the dynamic complexity of cellular processes on both the DNA and RNA level and how slight perturbations of those pathways contribute to the development of diseases like cancer," said Professor Roland Eils from DKFZ. "Therefore, it is of the utmost importance to be able to obtain quantitative precise measurements. We are confident that this collaboration with Life Technologies will help us generate the highest quality data possible using the SOLiD(TM) technology."

http://www.lifetechnologies.com/news-gallery/press-releases/2010/life-technologies-partners-with-german-cancer-research-center-to.html

---------------------------

The SOLiD PI System, designed in partnership with Hitachi High-Technologies Corporation, will provide individual researchers and sequencing core laboratories with a cost-effective instrument that will deliver an accuracy level of 99.99 percent. The system uses the same highly-accurate ligation-based sequencing technology as the SOLiD 4 System, and coupled with a streamlined workflow, is engineered to deliver high-quality, sample-to-mapped data in as little as two days. Designed to generate up to 50 gigabases (Gb) of mappable sequence data per run, equivalent to up to 8 Gb per day, this powerful, yet intuitive system will support a breadth of next-generation sequencing applications that include, SNP calling and detection, targeted resequencing, whole transcriptome analysis and digital gene expression analysis

http://www.lifetechnologies.com/news-gallery/press-releases/2010/life-technologies-debuts-solidtm-pi-system-expands-genetic-sequencing-portfolio.html

--------------------------------------

Whole Transcriptome Analysis vs. Microarrays

Global transcriptome analysis is of growing importance in understanding how altered expression of genetic variants contributes to complex diseases such as cancer, diabetes, and heart disease. Analysis of genome-wide differential RNA expression provides researchers with greater insights into biological pathways and molecular mechanisms that regulate cell fate, development, and disease progression.

Currently, the most widely used method to analyze global patterns of gene expression is the DNA microarray. However, because microarrays are hybridization-based, you cannot use them to detect RNA transcripts not included in your array design or from repeated sequences. Also, microarrays offer limited dynamic range to detect subtle changes in expression level of target genes, which is critical in understanding biological response to stimuli or environmental changes.

http://www.appliedbiosystems.com/absite/us/en/home/applications-technologies/solid-next-generation-sequencing/whole-transcriptome-analysis.html

-------------------------------------------

The SOLiD™ PI System* offers researchers high-quality sequencing data with the versatility to optimize runs for turn-around time or throughput. The SOLiD™ PI System is the next generation sequencer for every lab.

Benefits:

Powerful
50Gb mappable sequence with 99.99% accuracy
Intuitive
Streamlined workflows and easy-to-use software
Versatile
Optimize for speed, throughput, or number of samples
Affordable
Helping to make next generation sequencing accessible to every lab

http://www.appliedbiosystems.com/absite/us/en/home/applications-technologies/solid-next-generation-sequencing/next-generation-systems/solid-pi-system.html?CID=WE11304

Life Technologies buys stake in synthetic gene maker

2010-05-28T09:02:00.000-07:00

Life Tech buys stake in synthetic gene maker

Associated Press, 05.28.10, 09:35 AM EDT

CARLSBAD, Calif. -- Laboratory supplier Life Technologies Corp. said Friday it took a 74 percent stake in synthetic gene maker Geneart AG.

http://www.forbes.com/feeds/ap/2010/05/28/business-health-care-us-life-technologies-geneart_7644519.html

----------------

Gene Synthesis Services: GENEART provides in silico gene optimizations based on its proprietary GeneOptimizer® software. The respective gene sequences are produced using GENEART’s nano-scale high throughput GeneAssembler® technology platform.

Gene Evolution Services: Based on an optimized master gene the GENEART Gene Evolution Business Unit generates individual target-oriented gene variants and specific or randomized gene libraries via directed evolution. Such gene libraries may contain up to 100 billion (10¹¹) variants of a master gene. This large number of variants is for example useful to identify improved drug candidates or industrial enzymes.

Plasmid Services: GENEART offers to insert (=clone) the produced synthetic genes and gene libraries into plasmid vectors (transport vehicles). These plasmids are used to integrate the synthesized genes into the customer-preferred cell factory (bacteria, yeast, mammalian cells, etc.) for the purpose of propagating the plasmid or to produce the desired protein. GENEART also designs and constructs plasmid vectors according to customer specifications. Plasmids are delivered in any desired quantity from research grade all the way up to cGMP if required.

Cell Lines and Proteins: GENEART produces stable mammalian cell lines and transiently transfected cells, preferrably using optimized genes subcloned into suitable expression vectors, that produce the protein of choice. This enables customers to outsource the complete work from gene to protein and defines GENEART as a competent partner for academic and industry during all steps of the development of DNA and protein based biopharmaceutical products.

http://www.geneart.com/

Vertex Pharmaceuticals Breakthrough for Hepatitis C patients.

2010-05-27T12:59:00.000-07:00

Vertex’s telaprevir compound, when given in combination with two standard drugs, was able to eradicate any detectable sign of the hepatitis C virus in the blood for 75 percent of patients a full 24 weeks after they completed their course of therapy, Vertex said today in a statement. That is compared with 44 percent who did that well on a typical 48-week course of the usual drugs, pegylated interferon alpha and ribavirin. The results, which essentially represent the rate of clinical cures, were from a pivotal study of 1,095 patients known as “Advance.”

http://www.xconomy.com/boston/2010/05/25/vertex-hepatitis-c-drug-passes-pivotal-test-cures-three-out-of-every-four-patients/
------------------

"This study confirmed the substantial antiviral effects of telaprevir and showed an increased antiviral effect of telaprevir combined with peginterferon alfa-2a." (HEPATOLOGY 2007;46:640-648.)

http://assets0.pubget.com/pdf/17879366.pdf
-----------------

Current Project Pipeline

http://www.vrtx.com/current-projects.html

------------------------

YouTube Video: Telaprevir Anti-viral drug

Vertex Pharmaceuticals Inc

www.vrtx.com

11010 Torreyana Road

San Diego, CA 92121-1103

(858) 404-6600

----------------

Congress Looking into Pathway Genomics Genetic Testing Kits

2010-05-20T07:04:00.000-07:00

Congress is so far behind the times it's freaking out about the proven science of genetic testing provided by Pathway. I guess the real science of Biotech is largely unknown by even members of Congress. Is the public really ready for what's in store for them in the next couple of years?

WASHINGTON—A House panel is investigating personal genetic test kits currently sold over the Internet after one company proposed selling its kits through stores operated by Walgreen Co. and CVS Caremark Corp.

Last week, Pathway Genomics, a closely held firm based in San Diego, announced plans to sell its Insight Saliva Collection Kit through 6,000 Walgreens stores for between $20 to $30 a test. Saliva collected from the test would be sent to the company and analyzed for an additional price of $79 to $249.

The test, which Pathway currently sells through its website, is designed to predict a person's risk for developing certain diseases or how they might respond to certain drugs. It can also predict the risk of 37 genetic diseases caused by recessive genes that might be passed to a child from parents.

http://online.wsj.com/article/SB10001424052748704691304575254844175966082.html?mod=WSJ_hps_MIDDLEFifthNews

Gene tests must be approved by the FDA, official says

2010-05-17T08:45:00.000-07:00

This week’s demand for information from closely held Pathway Genomics of San Diego, which planned to sell its test at Walgreen Co. stores starting today, shows the agency is ready to be more muscular in exercising its authority, said Ira Loss, a senior health policy analyst at Washington Analysis LLC.

Pathway’s test kit aim to provide information about how customers’ genes affect their risk for developing 26 health conditions and the likelihood of passing any of 37 inherited conditions to unborn children. It also describes how customer’s genes affect their propensity to respond to such drugs as Bristol-Myers Squibb Co.’s blood-thinner Plavix as well as cholesterol-lowering statins such as Pfizer Inc.’s Lipitor.

http://www.businessweek.com/news/2010-05-14/personal-gene-testing-companies-need-u-s-clearance-fda-says.html

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With the Pathway Genomics Personal DNA Test, our certified geneticists scan your DNA for known genetic risk markers associated with adverse health conditions and drug interactions, with more tests are just over the horizon. Some markers have been researched more thoroughly than others, yet scientific knowledge advances rapidly. That is why we offer DNA HealthGuard™ with every Personal DNA Test. DNA HealthGuard™ automatically notifies you when new science and updates become available.

We uncover your deep ancestry by taking giant leaps into the past, going back more than 10,000 years. We test both your mitochondrial DNA (mtDNA), which is passed down from mother to child and reveals your direct maternal ancestry; and your Y-chromosome (Y-DNA, males only), which is passed down from father to son and reveals your direct paternal ancestry. Our ancestry DNA tests cover more than 1000 maternal and over 200 paternal haplogroups!

http://www.pathway.com/how_it_works

ADVENTRX Pharmaceuticals gets $19.2 Million more funds

2010-05-12T13:11:00.000-07:00

May 07, 2010 (Datamonitor Financial Deals Tracker via COMTEX) -- ADVENTRX Pharmaceuticals, Inc., a US-based biopharmaceutical company, has completed a registered direct offering of Series F convertible preferred stock for total gross proceeds of approximately $19.2 million.
Announcement (May 3, 2010):

ADVENTRX Pharmaceuticals has signed agreements to purchase shares of its Series F convertible preferred stock pursuant to a registered direct offering to institutional investors, representing gross proceeds of approximately $19.2 million.

Under the agreement, investors has an option to convert their preferred stock to shares of ADVENTRX's common stock at a conversion price of $3.70 per share and will accrue a 2.19% cumulative dividend until May 6, 2020. If the convertible preferred stock is converted at any time prior to May 6, 2020, ADVENTRX will pay the holder an amount equal to the total dividend that would accrue on the convertible preferred stock from the conversion date through May 6, 2020, or approximately $219.45 per $1,000 stated value of convertible preferred stock converted, less any dividend payments made with respect to the converted convertible preferred stock. Approximately $4.2 million of the gross proceeds will be placed in an escrow account, which amounts will be released to make the dividend and other payments as described above.

http://news.tradingcharts.com/futures/3/0/139336103.html

Lead Product Candidates

We are currently focused on seeking regulatory approval for and commercializing two late-stage product candidates in the U.S., ANX-530 (vinorelbine injectable emulsion) and ANX-514 (docetaxel injectable emulsion), which are novel emulsion formulations of currently marketed chemotherapy drugs. We believe ANX-530 and ANX-514 may improve the safety of and have greater commercial potential than the currently marketed reference products, Navelbine® (vinorelbine tartrate) Injection and Taxotere® (docetaxel) Injection Concentrate, respectively, by:

Reducing the incidence and severity of adverse effects; and

Improving their pharmacoeconomics and convenience to healthcare practitioners and patients.

Reformulating existing pharmaceutical products is an increasingly common product lifecycle-management technique. A 2004 report on the U.S. drug market from BCC, Inc. projected that reformulations would grow from 62% of the market in 2003 to 79% in 2008. Finding new markets for and ways to modify and improve existing products is often an essential element of pharmaceutical companies' efforts to innovate and improve treatment outcomes in the context of patent expirations and competitive pressures.

Navelbine and Taxotere are intravenously-injected chemotherapy drugs commonly used to treat solid tumors. We believe the current formulations of these drugs have limitations, such as phlebitis, erythema, hypersensitivity reactions and fluid retention, that present opportunities for improvement. We are developing novel ways to formulate the active ingredient underlying each of these drugs that we believe will improve their safety profiles without adversely affecting efficacy. In addition, we believe our formulations may provide benefits to patients and practitioners that do not manifest themselves in traditional measures of safety or efficacy.

http://www.adventrx.com/products/

NAVELBINE is indicated as a single agent or in combination with cisplatin for the first-line treatment of ambulatory patients with unresectable, advanced non-small cell lung cancer (NSCLC). In patients with Stage IV NSCLC, NAVELBINE is indicated as a single agent or in combination with cisplatin. In Stage III NSCLC, NAVELBINE is indicated in combination with cisplatin.

http://www.rxlist.com/navelbine-drug.htm

•TAXOTERE is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.

•TAXOTERE in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer

+ many other cancers
http://www.rxlist.com/taxotere-drug.htm

Pathway Genomics to Sell Genetic Test @ Walgreens

2010-05-11T14:03:00.000-07:00

San Diego’s Pathway Genomics, which announced plans last July to offer consumers a personal genome test for $250, says it will begin selling its genetic test this week at about 80 percent of Walgreens stores nationwide, according to a front page story in today’s Washington Post.
“We believe the market is ready for this,” Jim Woodman, a Pathway Genomics vice president of corporate strategy, told the newspaper. “We think there’s more awareness of genetics these days.”
For $249, a prospective patient can get a suite of tests to determine whether they carry 23 specific genetic conditions, including diabetes and polycystic kidney disease, as well as their genetic risk for 23 health conditions, including heart attack, high blood pressure, lung cancer, and multiple sclerosis. Or, for $179, the company will test for either the 23 specific genetic conditions or test their risk for 23 health conditions.

http://www.xconomy.com/san-diego/2010/05/11/pathway-genomics-to-sell-over-the-counter-genetic-test-this-week/
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A.Order your Personal DNA Report online. When your Saliva Collection Kit arrives you will have everything you need to get started. Get free shipping when you order additional reports for your children, family, or friends.
B.Follow the easy step-by-step instructions to 1) accurately collect a small of amount saliva in the tube provided and 2) Collect: activate your private, password-protected account online.
C.Send Using the pre-paid Fed-Ex package included, send your sample to our secure onsite CLIA-certified lab, where your personal information is protected for privacy purposes.
http://www.pathway.com/how_it_works

Evotec AG (EVTG.F) Enters Into Integrated Drug Discovery Alliance With Genentech (RHHBY)

2010-05-10T08:43:00.000-07:00

HAMBURG, Germany, May 10, 2010 (GlobeNewswire via COMTEX) -- Evotec AG (Frankfurt:EVT) (TecDAX) today announced that it has entered into a multi-year integrated drug discovery alliance with Genentech Inc., a wholly owned member of the Roche Group (SWX:RO) (SIX:ROG) (Pink Sheets:RHHBY), to discover novel small molecule therapeutics.

Evotec will apply its integrated and innovative drug discovery platform in combination with its extensive disease biology expertise against targets nominated by Genentech. This will include assay development and high throughput screening, medicinal chemistry and structural biology. The aim of the collaboration is to deliver high quality leads and development candidates to support Genentech's research efforts.

http://www.biospace.com/news_story.aspx?NewsEntityId=179899

Abbiotec Gc-globulin (5E8) Antibody

2010-05-08T00:57:00.000-07:00

Mouse Monoclonal Antibody
Gc-globulin (5E8) Antibody

0.2 mg
$750.00
Each vial contains 0.2 mg IgG in 0.2 ml (1 mg/ml) of PBS pH7.4 with 0.09% sodium azide. Antibody was purified by Protein-A/

http://abbiotec.com/antibodies/gc-globulin-(5e8)-antibody
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Description

Gc-globulin is a plasma protein produced in the liver. Amongst its ligands are vitamin D, thus Gc-globulin is also called vitamin D-binding protein. Gc-globulin is furthermore part of the actin scavenging system, binding and removing monomeric actin from the blood stream. The molecular mass of Gc-globulin is approximately 50 kDa. The concentration of Gc-globulin in human plasma is app. 400 µg/ml. This antibody is specific for human Gc-globulin.

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Abbiotec, LLC
7985 Dunbrook Road, Suite A
San Diego, CA 92126

Phone: 1 858 586 0500
Toll Free: 1 800 854 7453
Fax: 1 858 586 6252

Novartis finds clues for universal E.coli vaccine

2010-05-04T12:01:00.000-07:00

* Initial tests of a vaccine in humans could come in 2012

* Huge potential market, but many years of work ahead

By Kate Kelland

LONDON, May 3 (Reuters) - Scientists at drugmaker Novartis (NOVN.VX) have found bacterial components they hope can be used to develop a vaccine to protect people against a range of dangerous Escherichia coli (E.coli) infections.

Certain strains of the bacteria cause diseases such as food-borne illnesses, urine infections and meningitis among newborns, in rich and poor countries alike.

"We know that we have the potential there, and this could mean that once you get vaccinated you could even be covered against all the different diseases that E.coli can cause," MariaGrazia Pizza, who worked on the study in Novartis's Italian research labs, said in a telephone interview.

http://www.reuters.com/article/idUSLDE6421AA20100503

Beckman Revises Forecast, Analysts, Investors Unfazed

2010-05-02T23:47:00.000-07:00

The recall of a profitable heart testing kit has given Beckman Coulter Inc. pause in its outlook for the rest of the year.

Last week, Beckman, a Brea-based maker of instruments and chemicals used by medical laboratories and researchers, lowered its 2010 outlook in the wake of issues related to a heart disease test run on one of its machines.

Beckman recalled that test—which detects troponin, a protein released after heart damage—when the Food and Drug Administration said changes were made to it without regulatory clearances.

The company is working with regulators to get the test, which runs on its DxI testing machines, back in use.

For now sales of troponin test kits are on hold. That prompted Beckman to lower its 2010 profit forecast to $307 million to $321 million, down from a previous outlook of $314 million to $324 million.

http://www.ocbj.com/news/2010/may/02/beckman-revises-forecast-analysts-investors-unfaze/