In spite of positive regulatory and business news, health stocks held to the rest of the markets on Thursday leaving biotech indices a bit in the red.
Noven Pharmaceuticals(NOVN Quote) said Wednesday after the close that the U.S. Food and Drug Administration sent a tentative approval letter for the company's Stavzor. The drug is for manic episodes related to bipolar disorder and used as a therapy for multiple types of seizures, as well as a preventative for migraine headaches. Tentative approval generally indicates the agency has concluded that a drug has met the required quality, safety and efficacy standards, but it cannot be marketed in the U.S. yet due to existing patents and/or exclusivity rights, according to the company. Noven expects the FDA's final approval by the end of July 2008. Shares rose a bit and then fell back 25 cents, or 1.72%, to $14.80 on Thursday. On the business side, Cell Therapeutics Inc.(CTIC Quote) said Thursday that it completed the buyout of Biogen Idec's(BIIB Quote) Zevalin for non-Hodgkin's Lymphoma (NHL). The drug is approved for NHL patients who've tried another therapy unsuccessfully. Per the deal announced in August, CTI made an upfront payment of $10 million in exchange for control of U.S. marketing, sales and development of Zevalin, and will pay an additional $20 million in milestone payments if Zevalin is approved as a first line, or initial, treatment for NHL. CTI will also pay sales royalties for Zevalin until at least December 2015, according to the companies.- Loading Comments...
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