FDAnews Drug Daily Bulletin
March 10, 2005 | Vol. 2 No. 49
The proliferation of clinical trial registries has started raising red flags among drug companies, some of which are starting to express concerns that making all clinical data publicly available will leave valuable trade secrets exposed.
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has given Chiron the go-ahead to operate its Liverpool plant for the first time since the vaccine-manufacturing facility's license was pulled five months ago.
Pfizer and sanofi-aventis have initiated the application process for its highly anticipated diabetes drug Exubera.
For the second time in a year, the FDA has rejected a request from Forest Laboratories to expand the indication for its antidepressant Lexapro.
AVANIR Pharmaceuticals has announced that, through a wholly owned subsidiary, it has acquired from IriSys, additional rights to Neurodex, AVANIR's late-stage drug candidate for the treatment of multiple central nervous system disorders, which was sublicensed from IriSys in 2000.
Applied Biosystems, an Applera Corporation business, has announced a collaborative research study with the National Center for Toxicological Research of the U.S. Food and Drug Administration (FDA/NCTR) whereby Applied Biosystems will use its Expression Array System and Rat Genome Survey Microarray to investigate the toxicity of a common class of diabetes drugs using samples provided by the FDA/NCTR.
Erie County Executive Joel Giambra's war on rising Medicaid costs is headed to the courts.
A former Biogen Idec Inc. manager accused the company of providing illegal discounts to doctors in an effort to increase sales of flagging products, including its psoriasis drug Amevive, Tuesday's Wall Street Journal reported.
Boulder's Sirna Therapeutics plans to relocate its headquarters to San Francisco, citing attractive financial incentives and the need to be near investment bankers and qualified workers.
Japanese biopharmaceutical company Sosei has announced that it has agreed with trading giant Itochu to form a strategic partnership.
Kobayashi Pharmaceutical announced March 8 that it has agreed with Combe International, a U.S. pharmaceutical company, regarding Kobayashi Combe, a 50/50 joint venture between Kobayashi and Combe.
MediciNova, a specialty pharmaceutical company that is publicly traded on the Hercules Market of the Osaka Securities Exchange, has announced that the underwriter of its recent initial public offering of 30,000,000 shares of common stock has exercised its over-allotment option to purchase 1,573,000 shares of common stock from MediciNova at a price of 370 Yen per share, net of underwriting discount.
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