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Shire Pharmaceuticals Group said it signed an agreement to globally develop
and commercialize a new attention-deficit/hyperactivity disorder (ADHD) compound
from New River Pharmaceuticals.
Bayer AG, the maker of Alka-Seltzer stomach remedies and inventor of aspirin,
has completed its purchase of Roche Holding AG's non-prescription health-care
unit for 3.6 billion Swiss francs ($3.1 billion.) European antitrust regulators
approved Bayer's acquisition after the German drug company agreed to divest
or license three pharmaceuticals in two countries.
Alnylam Pharmaceuticals, a leading therapeutic RNA interference (RNAi) company,
has received a $7 million milestone payment from Merck in connection with the
September 2003 strategic collaboration between the two companies to develop
RNAi technology and therapeutics.
Noven Pharmaceuticals has earned a $3 million success
fee for attaining a development milestone under its development collaboration
with P&G Pharmaceuticals, a subsidiary of The Procter & Gamble Company.
A federal court has blocked a provision in a Washington, D.C., prescription
drug law that would have imposed fiduciary duties on pharmaceutical benefit
managers (PBMs) and required them to disclose proprietary financial information
negotiated with drugmakers.
The FDA has reopened the docket on the agency's premarket notification program
for new dietary ingredients (NDIs) after receiving requests from trade associations
representing dietary supplement makers.
Pharmaceutical executives are among the featured speakers at a series of upcoming
town hall meetings on proposals to reform the U.S. patent system, including
legislation that would allow firms to challenge the validity of patents at their
issuance rather than in the courts.
The FDA has issued a warning letter to Lincare and its subsidiary, Reliant Pharmacy
Services, informing them that their practice of manufacturing compounded drug
products is in violation of the Compliance Policy Guide (CPG) of the Federal
Food, Drug, and Cosmetic Act (FDCA).
Timing and unprecedented funding propelled several Birmingham-based biotechnology
companies to the forefront of national development trends in 2004, strengthening
a sector often relegated to the halls of academia.