FDAnews Drug Daily Bulletin
Feb. 22, 2005 | Vol. 2 No. 37
While drugmakers stand to gain financially under new cost estimates for the Medicare Rx drug benefit, the plan's significantly higher price tag also gives new ammunition to lawmakers who want the HHS to negotiate drug prices.
Health Canada has suspended the market authorization of Shire Pharmaceuticals' Adderall XR, saying a recent review of Shire safety data revealed an association between the attention-deficit/hyperactivity disorder drug and heart-related deaths and strokes in both children and adults.
The FDA's current policy on drug compounding will be tested in court later this year, as a federal judge has given the green light to a lawsuit filed against the agency by a coalition of 10 pharmacies.
Drugmakers seeking approval of a product intended for use in women of reproductive age should conduct lactation studies on the drug, even in cases when the product would rarely be used in lactating women, according to a new FDA draft guidance.
Spectrum Pharmaceuticals announced that it has initiated a challenge of the patent listed by GlaxoSmithKline in connection with GlaxoSmithKline's Imitrex injection 6mg/0.5mL
Sumitomo Pharmaceuticals has announced that it has signed a memorandum to transfer sales of its proprietary antitumor drug Calsed to Nippon Kayaku.
Five St. Louisans are making a bet on biotech. A big one. Dr. Frank O'Donnell plans to take his $26 million Accentia Biopharmaceuticals public.
Softwall Equipment has announced that it has agreed to acquire Inncardio, a Delaware corporation engaged in the business of acquiring, developing and commercializing pharmaceutical products targeted at various Cardiovascular diseases.
Novartis announced that it will buy generic drugmakers Eon Labs of the United States and Hexal of Germany for $8.3 billion, creating the world's largest generic drug company.
Quintiles, the North American clinical development subsidiary of Quintiles Transnational, and the University of North Carolina at Chapel Hill have announced the creation of a new alliance for clinical research.
Ranbaxy Laboratories will set up a majority-owned joint venture in Mexico to tap the growing demand for generic drugs there. The joint venture with a Mexican firm will cater to the marketing and distribution demands of the local market.
Newron Pharmaceuticals SpA, a research and development company focused on novel CNS therapies, announced the raising of EUR 30 million (fully committed), out of which EUR 23 million closed.
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