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Manufacturers should begin nonclinical testing of all new investigational drugs
to determine what, if any, impact they have on a patient's immune response,
according to a new FDA draft guidance released under the auspices of the International
Conference on Harmonisation.
Eli Lilly is placing bar codes on individual vials of nine of its insulin products
to ensure accurate dispensing to hospitalized patients, the company announced.
Merck has been unable to determine exactly why its arthritis
pain drug Vioxx causes increased rates of heart attacks and strokes, but the
drugmaker still believes that it's premature to draw conclusions about the entire
class of Cox-2 drugs.
President Bush's proposed fiscal 2006 budget would boost the FDA's drug safety
efforts by an additional $6.5 million, giving the agency a total of $747 million
for human drugs and biologics programs -- an overall increase of $26 million
from fiscal 2005 levels.
CoTherix has announced that the underwriters of its follow-on offering have
exercised their over-allotment option to purchase an additional 250,000 shares
of common stock from CoTherix to be offered at the public offering price of
$8.90 per share.
Swiss pharmaceuticals giant Novartis is in talks to buy German generic-drugs
maker Hexal and two of its subsidiaries for up to €4.5 billion (R35.6 billion),
the daily Die Welt reported on Tuesday.
Vertex Pharmaceuticals and Avalon Pharmaceuticals have announced that they have
entered into a licensing agreement for the development of the investigational
agent VX-944 in oncology indications.
The Indian pharmaceutical sector has begun its seismic shake-up following the
introduction of new laws granting patent protection to medicines on Jan. 1.
Scientists at SIGA Technologies and privately held TransTech Pharma (TTP) announced
the receipt of a $2.7 million challenge grant from the National Institutes of
Health (NIH) to support the development of protease inhibitors to treat orthopoxvirus
infections, such as smallpox and monkeypox.