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July 25, 2008 |
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GSK teams with Aspen to sell generic medicines GlaxoSmithKline announced a plan to sell off-patent generic drugs in developing countries through a deal with Aspen, a South African drugmaker. The agreement, which involves 1,200 treatments from Aspen, is expected to bolster GSK's presence in India and other emerging markets. Financial Times (7/23) Genzyme faces setback with Myozyme production Genzyme said plans to boost production of Myozyme, a treatment for Pompe disease, may be delayed further because the FDA referred its proposed manufacturing changes to an advisory panel. The experts are set to review the process in October. Forbes/Associated Press (7/23) Emergent, U.K. university cooperate to create TB vaccine Emergent BioSolutions and the University of Oxford formed the Oxford-Emergent Tuberculosis Consortium, a joint venture that focuses on developing a tuberculosis vaccine. Emergent secured the marketing rights for the product, which is expected to enter midstage trials next year. American City Business Journals/Washington, D.C. (7/23) Advanced Cancer Therapeutics secures HPV-vaccine deals Advanced Cancer Therapeutics signed a deal to acquire exclusive global development and commercialization rights to certain human papillomavirus vaccines developed by University of Louisville researchers. The company also reached an agreement with Kentucky BioProcessing that grants it rights to a process for making an HPV vaccine derived from the tobacco plant. American City Business Journals/Louisville, Ky. (7/23) Novartis, Dynavax to develop "universal" flu shots Novartis Vaccines and Diagnostics agreed to supply its trivalent influenza vaccine that will be used in developing Dynavax Technologies' experimental "universal" flu vaccine. In return, Novartis gains the exclusive option to discuss development and marketing deals with Dynavax. Financial terms of the partnership were not disclosed. American City Business Journals/San Francisco (7/23)
FDA: Doctors should use genetic test before prescribing Abacavir The FDA is expected to release an advisory today that calls on doctors to use a genetic test before prescribing abacavir -- sold by GlaxoSmithKline under the name Ziagen -- to prevent severe allergic reactions in patients carrying an immune-system gene variant. The recommendation will be included in a black-box warning on Ziagen's new label, which will also mention the increased risk of heart attack based on "inconclusive" study data. The New York Times (7/24) HHS: Immunize health care workers first if pandemic strikes Emergency-room staffers, nurses and other health care workers would be the first to get influenza shots in case of a U.S.-wide pandemic, according to an HHS guidance released Wednesday. An expert on infectious diseases criticized the plan, saying it fails to "support the manufacturing and transportation system" of bringing other drugs such as antibiotics from overseas to the U.S. Yahoo!/Reuters (7/23) NICE upholds ruling limiting price of drug-coated stents The British National Institute for Health and Clinical Excellence denied an appeal from Johnson & Johnson's Cordis unit for a ruling that limits the price of drug-coated stents to $599 more than the cost of bare-metal stents. Drug-eluting devices "will continue to be an important treatment option for patients who would be at high risk of requiring further interventions if a bare-metal stent was used instead," NICE CEO Andrew Dillon said. Bloomberg (7/23)
Discovery of gene variant may lead to test for myopathy British researchers identified a variation of the SLCO1B1 gene that causes 60% of cases of myopathy -- serious muscle weakness and pain -- in individuals who take high doses of cholesterol-lowering statins. The discovery boosts hope for the development of a test that detects people who are at high risk for the condition. The Star-Ledger (Newark, N.J.) (7/23) , The Wall Street Journal/Associated Press (subscription required) (7/23) Studies: Isentress works in HIV patients with limited options Two studies backed by Merck & Co. found that its drug Isentress was effective compared with placebo in inhibiting HIV replication in patients who did not respond to other medications. The finding suggests that additional treatment with Isentress may be better than standard therapy alone for HIV patients with limited options, the researchers said. WebMD (7/23) , MedPage Today (free registration) (7/23) Progen halts trials of liver cancer drug Progen Pharmaceuticals stopped late-stage trials of PI-88, an experimental treatment for liver cancer, and said it was considering purchase offers for the drug. The Australian drugmaker will also end the development of another liver cancer drug, PI-166, because Nexavar, a rival treatment from Bayer and Onyx Pharmaceuticals, was approved last year in the U.S. and Europe. Bloomberg (7/23) Statins may extend lives of kidney-transplant patients Cholesterol-reducing statins may help extend the lives of patients who underwent kidney transplants, according to an Austrian study. Researchers reported that 73% of patients who took statins at the time of their operation were still alive after 12 years, compared with 64% of those who did not take the drugs. Yahoo!/Reuters (7/23) |
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