FDAnews Drug Daily Bulletin
Feb. 17, 2005
| Vol.
2 No.
34
President Bush's proposed fiscal 2006 budget would boost the FDA's drug safety efforts by an additional $6.5 million, giving the agency a total of $747 million for human drugs and biologics programs -- an overall increase of $26 million from fiscal 2005 levels. Merck has been unable to determine exactly why its arthritis pain drug Vioxx causes increased rates of heart attacks and strokes, but the drugmaker still believes that it's premature to draw conclusions about the entire class of Cox-2 drugs. Eli Lilly is placing bar codes on individual vials of nine of its insulin products to ensure accurate dispensing to hospitalized patients, the company announced. Manufacturers should begin nonclinical testing of all new investigational drugs to determine what, if any, impact they have on a patient's immune response, according to a new FDA draft guidance released under the auspices of the International Conference on Harmonisation. Seeking to lure the state's lucrative biomedical and biotech industries, Los Angeles city and county officials announced plans Tuesday to develop a vast tech park to take on the industry's great hubs. Researchers at the University of Bath have won a grant to help produce a drug that could stop flu and several other diseases from replicating in humans. Santarus said it will receive more than $10 million from Tap Pharmaceutical after prevailing in a legal dispute with the maker of Prevacid, the nation's top selling heartburn medicine. DOR BioPharma announced that it has initiated a rational drug design program to identify oral, small molecule drugs to counter the deadly effects of Botulinum toxin exposure. Shares of Encysive Pharmaceuticals have climbed on the news that the Bellaire-based biotech company reported positive test results for its pulmonary arterial hypertension drug. Sigma-Aldrich Corporation announced that it has signed a definitive agreement to acquire the Proligo Group (Proligo) from Degussa AG (Frankfurt: DGXG.DE). Pfizer Inc's experimental drug for a deadly form of stomach cancer has been recommended for so-called orphan drug status in the European Union, the European Medicines Agency said. Voyager Pharmaceutical Corp. announced the completion of its 48-week Phase II Alzheimer's disease study -- a major clinical achievement for the biopharmaceutical company focused on diseases of aging and development. |
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