Monday, August 19, 2013

FDA OKs new flu vaccine from GlaxoSmithKline

BIA: Biotech investments are at risk under U.K. price scheme | FDA awards orphan designation to Epizyme leukemia candidate | FDA expands clearance for Immunetics' bacteria assay
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August 19, 2013
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FDA OKs new flu vaccine from GlaxoSmithKline
The FDA has approved GlaxoSmithKline's Flulaval Quadrivalent vaccine for two A and two B strains of seasonal influenza. "Trivalent vaccines do reduce influenza risk, even in years when a vaccine strain-mismatch occurs, though quadrivalent influenza vaccines are the important next step in broadening strain coverage," said GSK's Dr. Leonard Friedland. The vaccine will be distributed for the coming flu season, and it is GSK's second quadrivalent flu vaccine to be approved in the U.S. Family Practice News (8/16), PMLive.com (U.K.) (8/19)
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Columbia EMBA-Americas
Columbia Business School is pleased to announce EMBA-Americas, a new program designed for executives throughout the Americas, whose location precludes them from attending Columbia's EMBA-New York Program. EMBA-Americas meets one week per month in NYC with residences in San Francisco, São Paulo, and Toronto. To learn more, sign up for an information session.
 
Health Care & Policy
BIA: Biotech investments are at risk under U.K. price scheme
The new statutory system of value-based pricing being planned in the U.K. for branded drugs could endanger future investments in biotechnology, the BioIndustry Association said. The Department of Health is making the shift next year, and the assessment of new drug prices will be handled by the National Institute for Health and Care Excellence. "The perception of the U.K. as a market for innovative products has an important bearing not only on the global investment decisions of multinational biopharmaceutical companies, but also upon private investment to support early-stage bioscience companies," BIA CEO Steve Bates said. PharmaTimes (U.K.) (8/16)
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FDA awards orphan designation to Epizyme leukemia candidate
The FDA granted orphan-drug status to Epizyme's EPZ-5676, an experimental treatment for acute leukemia where the myeloid/lymphoid, or mixed-lineage, leukemia with gene rearrangement is caused by chromosomal translocation. Epizyme projects that it could submit the drug, which is in early-stage trials, for FDA approval by 2016. American City Business Journals/Boston/bioflash blog/Mass High Tech (8/16)
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FDA expands clearance for Immunetics' bacteria assay
The FDA has granted Immunetics expanded clearance for its BacTx test to be used in identifying the presence of bacteria in apheresis platelets. The assay, which was previously cleared for point-of-care screening of platelets derived from whole blood, can now be used as an ancillary tool to transfusion services as well as for quality testing of leukocyte-reduced apheresis platelets within a period of 24 hours after transfusion. American City Business Journals/Boston/BioFlash blog/Mass High Tech (8/15)
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GW Pharmaceuticals seeks FDA nod for spasticity drug trial
GW Pharmaceuticals filed an investigational new-drug application with the FDA to conduct a pivotal, late-stage trial of Sativex as a treatment for spasticity in multiple sclerosis patients. The trial, which is expected to begin next year, will be carried out by GW's partner Otsuka Pharmaceutical. The drug is also in late-stage clinical development as a treatment for cancer pain. Pharmaceutical Business Review Online (8/16)
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Lilly-Boehringer's diabetes treatment does well in late-stage study
Elderly patients with type 2 diabetes who received Boehringer Ingelheim and Eli Lilly and Co.'s dipeptidyl peptidase-4 inhibitor linagliptin for 24 weeks showed significant reductions in blood glucose levels compared with those treated with a placebo, a late-stage trial found. The safety and tolerability profile was comparable to that of the placebo. Genetic Engineering & Biotechnology News (8/16)
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Company & Financial News
N.Y. biotech hopes to raise $85M from IPO
Ophthotech plans an initial public offering that could raise $85 million, according to an SEC filing. The New York-based firm will use the money to support a Phase III trial of Fovista, its lead drug candidate for age-related macular degeneration, and advance development of another drug candidate for wet AMD. Xconomy/New York (8/15)
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Genalyte releases biomarker panel for type 1 diabetes detection
Genalyte has introduced its first biomarker panel that can detect type 1 diabetes early by measuring seven autoantibodies linked to destroyed pancreatic islet cells seen in patients with the condition. The disposable silicon-chip-based test, which takes only 15 minutes to generate results, was developed using a $500,000 Small Business Innovation Research grant received by the company last year. MedCityNews.com (8/15)
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Food & AgricultureSponsored By
Spain's biotech maize fields increase to record size
Spain's total planted area of MON810 biotech maize reached 138,543 hectares in 2013, a 19% increase from the previous year, according to data from the ministry of agriculture. Monsanto's borer-resistant maize now accounts for almost 33% of the country's maize fields. Farmers Weekly Interactive (U.K.) (8/16)
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EvaluatePharma World Preview 2013, Outlook to 2018
In this sixth annual edition report, Evaluate brings together many of our analyses to provide top level insight into the expected performance of the industry between now and 2018. The report highlights trends in Rx drug sales, patent risk, R&D spend and sales by therapy area as well as a brief review of 2012 performance. Download your complimentary report now.

Hot Topics
Industrial & Environmental
Researchers find way to lessen plant's lignin content
A team of scientists led by Belgian molecular geneticist Wout Boerjan found that switching off a specific gene in the Arabidopsis thaliana caused the plant's lignin content to decline by 36% while quadrupling its cellulose yield when processed. If the technique works in other biofuel crops, it would drive down the cost of making cellulosic biofuel, the researchers said. Fine-tuning the process might make it possible to produce trees that are just as sturdy as unaltered varieties but are easier to process into biofuels, the researchers added. ScienceMag.org (8/15)
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Project Lead, DevelopmentLpath, Inc.San Diego, California
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