FDAnews Drug Daily Bulletin
Jan. 18, 2005
| Vol.
2 No.
12
Spending growth for prescription drugs in the U.S. decelerated at a rapid rate in 2003, according to new data released by the Centers for Medicare & Medicaid Services (CMS). Wyeth has agreed to support an amendment to a nationwide legal settlement with users of its fen-phen products -- a move that would guarantee payments to the largest group of members involved in the class action lawsuit. Several prominent Democrats have sent a letter to the Government Accountability Office (GAO) asking the watchdog agency to examine "covert propaganda" being employed by the Bush administration, including actions related to the Medicare Modernization Act (MMA). It would be a mistake to remove the FDA's drug safety office from the agency as a way to ensure total independence from the new drug office, says an industry expert who cautioned the FDA and lawmakers not to overreact to recent adverse events surrounding Cox-2 inhibitors. An Australian biotech company has acquired Myomatrix Therapeutics of Rensselaer, N.Y. Terms of the deal were not disclosed. Cytopia Inc., a wholly owned subsidiary of Cytopia Ltd., plans to add staff once the merger is completed. Shreefal Mehta, Myomatrix CEO, will be vice president of the merged entity. Shire Pharmaceuticals remains committed to protecting the patents which it has relating to Adderall XR, its product for treatment of attention-deficit/hyperactivity disorder (ADHD). A Nashville biotech start-up has secured a global licensing pact for a new technology that detects, neutralizes and removes bacterial toxins. Quintiles Transnational has said its restructuring will cost an additional 316 jobs -- bringing the number of announced layoffs since November to 546. Pharmacy benefits manager Caremark on Monday said all the products it sells come from licensed wholesalers, a day after a published report said Illinois regulators were investigating whether it resold drugs that had been returned by patients. Oxygen Healthcare, promoted by a group of UK-based NRIs, is setting up a world-class research facility in Ahmedabad to offer contract chemistry in drug discovery for bio-pharmaceutical companies based in Europe and the U.S. A pharmaceutical company has issued a nationwide recall of approximately 500 bottles of a drug used to treat attention-deficit/hyperactivity disorder and narcolepsy. Women's rights groups seeking easier access to emergency contraception are pressuring U.S. regulators as they try to decide whether to approve a nonprescription "morning-after" pill. |
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