FDAnews Drug Daily Bulletin
March 8, 2005
| Vol.
2 No.
47
At the request of the FDA, U.S. marshals have seized more than $13,000 worth of adulterated and misbranded dietary supplements from a Pennsylvania firm believed to be marketing products containing ephedrine alkaloids. Biogen Idec and Elan have suspended sales of their multiple sclerosis (MS) drug Tysabri following reports that the product might have contributed to a pair of serious adverse events, including one patient death. Mylan Laboratories has officially closed the door on its planned merger with King Pharmaceuticals, announcing that it is not moving forward with the $4 billion deal. Acting FDA Commissioner Lester Crawford believes the science is available for the FDA to move forward on follow-on biologic products, but he told a recent industry conference that the FDA still has many kinks to work out on the regulatory front. Sanofi-Aventis will expand its research and development center in Budapest, Chairman and Chief Executive Jean-Francois Dehecq told reporters Monday. Gene Network Sciences has signed a drug development contract with Johnson & Johnson Pharmaceutical Research & Development (J&JPRD), a division of Janssen Pharmaceutica N.V. Biotechnology company Pluristem Life Systems has announced that it has completed private placements amounting to $3.2 million. ViroLogic has announced that it had entered into an agreement with AstraZeneca to conduct a cancer biomarker study with application to Iressa, AstraZeneca's selective epidermal growth factor receptor kinase inhibitor. Solexa and Lynx Therapeutics has announced the completion of their previously announced business combination transaction. The UK government will spend £1 billion on biotechnology by 2008, according to newly announced science spending plans. GlycoGenesys, a biotechnology company developing carbohydrate-based drugs, has announced that it has entered into definitive agreements to close on gross proceeds of $6,500,000 from institutions in exchange for issuance of 6,500 shares of convertible, redeemable Series D Preferred Stock, currently convertible into 6,500,000 shares of common stock, and warrants to purchase 6,500,000 shares of common stock currently at $1.23. Dermatologists know that a class of drugs called retinoids can promote skin growth and possibly healing. Six-year-old Nuada Pharmaceuticals has laid off its remaining 13 employees and filed for liquidation. |
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