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The FDA is preparing to release a draft guidance that will contain details about
a new investigational new drug (IND) application process that it hopes will
enhance postdiscovery drug development, according to a top agency official.
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.
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.
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.
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.
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.
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.