FDAnews Drug Daily Bulletin
March 18, 2005 | Vol. 2 No. 55
The FDA has issued a public health warning about the potential cancer risks of two eczema drugs -- Novartis Pharmaceutical's Elidel and Fujisawa Healthcare's Protopic.
Indian drugmaker Zydus Cadila has entered into an agreement with a unit of Tyco Healthcare that will enable it to tap into the U.S. generics market.
The FDA has issued a warning letter to dietary supplement maker ABCO Laboratories, accusing the company of promotional activities that violate the Federal Food, Drug, and Cosmetic Act.
The best way for drug and device manufacturers to receive the fastest possible coverage decisions from the Centers for Medicare & Medicaid Services (CMS) is to submit all relevant information on their products during the initial request for a Medicare national coverage determination (NCD), the agency states in a new draft guidance.
Cancer drug developer ImmunoGen has said that French drug company sanofi-aventis Group initiated clinical testing with huMy9-6-DM4 -- the anti-CD33 Tumor-Activated Prodrug compound that it licensed from ImmunoGen -- triggering a $2 million milestone payment to the company.
Targacept Inc. has filed with securities regulators to withdraw its initial public offering.
Abbott India Ltd has informed BSE that the company entered into a fresh distribution agreement with Novo Nordisk India Pvt Ltd for sale and distribution of their insulin products in India for the period Jan. 1, 2005, to Dec. 31, 2006.
Innovive Pharmaceuticals, a biopharmaceutical company headquartered in Manhattan, announced it has licensed worldwide rights for the use of Opioid Growth Factor (OGF) in oncology from Penn State.
Metabasis Therapeutics has said two clinical trials of its experimental diabetes treatment were halted after two patients who were also taking the widely used diabetes drug metformin suffered serious health problems.
Cancer vaccine developer Epimmune Inc. said it agreed to merge with IDM SA, a privately held French biopharmaceutical company, in an all-stock transaction. Under terms of the agreement, IDM shareholders will receive about 3.77 shares of Epimmune common stock for each IDM share held.
Neurogenetics, a clinical-stage biopharmaceutical company focused on discovering and developing breakthrough small molecule drugs to treat diseases and disorders of the central nervous system, has changed its name to TorreyPines Therapeutics.
Inex Pharmaceuticals Corp. has agreed to end a collaboration with Enzon Pharmaceuticals Inc. for developing the Marqibo cancer drug after U.S. regulators rejected accelerated approval for the medicine.
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