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The agreement between the FDA and the Centers from Medicare & Medicaid Services
(CMS) to conduct parallel reviews of products -- which would allow drugmakers
to receive both a drug approval and reimbursement coverage simultaneously --
could speed some products to market, but it also raises concerns for the pharmaceutical
industry, according to experts.
All medically necessary drugs must be available under Medicare drug plans, according
to the final rules implementing the massive Rx benefit -- a decision that addresses
key concerns by drugmakers and lawmakers that some drugs could have been excluded
under the proposed guidelines.
A federal appeals court has ruled against Teva Pharmaceutical
in its attempt to force a district court to hear its patent challenge to Pfizer's
antidepressant Zoloft -- a ruling that is a blow to generics seeking to use the
declaratory judgment provision in the 2003 drug patent reforms to settle patent
disputes.
Although the FDA has made little headway on developing a formal approval pathway
for follow-on biologics, drug developers aren't sitting on their hands waiting
for the agency to act.
Hollister-Stier Laboratories, the Spokane pharmaceutical maker, is taking an
early first step toward a major manufacturing expansion at its northeast Spokane
plant.
German health ministry representatives will be meeting with U.S. officials in
February regarding concern over the German health reform's effect on U.S. pharmaceuticals,
according to a prerelease of an article scheduled to be published in Die Welt.
The U.S. Army Edgewood Chemical Biological Center has enlisted Icoria to help
it with research that eventually could be used to try to discover new treatments
for low-level chemical warfare agent exposure.
Cyntellect, a privately held biotechnology company, has announced that an undisclosed
U.S.-based biotechnology company has entered into a formal agreement to access
Cyntellect's Cell Xpress service.
Lupin, the Mumbai-based pharma major, has announced that its wholly owned subsidiary,
Lupin Pharmaceuticals (LPI), has entered into an alliance with Cornerstone BioPharma
as a promotion partner in the U.S. for its Suprax (cefixime) anti-infective.