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The FDA has given final approval to Barr Laboratories, Mylan Laboratories and
Ivax Pharmaceuticals for generic versions of Shire Pharmaceuticals' Agrylin
(anagrelide HCl) capsules in 0.5- and 1-mg doses.
The FDA has granted tentative approval to Mylan Pharmaceuticals' abbreviated
new drug application for terbinafine hydrochloride tablets in a 250-mg dose.
The FDA has approved Bausch & Lomb's single-indication orphan drug Retisert
(fluocinolone acetonide intravitreal implant) for the treatment of chronic noninfectious
uveitis, a sight-threatening inflammatory disease.
Genta has announced that preclinical data have shown Genasense, the company's
lead anticancer drug, may enhance the antitumor activity of gefitinib (Iressa;
AstraZeneca) in non-small cell lung cancer (NSCLC).
Vical has announced that initial human testing of an investigational vaccine
targeting West Nile virus has begun at the NIH's Clinical Center in Bethesda,
Md.
Adventrx Pharmaceuticals has presented CoFactor toxicity and pharmacodynamics
data collected from the company's ongoing CoFactor Phase II clinical trial in
metastatic colorectal cancer.
Medicure has received a recommendation to continue its Phase II/III MEND-CABG
trial following a meeting of the independent data safety monitoring board (DSMB).