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The FDA has granted Celgene priority review designation for its new drug application
for Revlimid with a Prescription Drug User Fee Act (PDUFA) date of Oct. 7.
Columbia Laboratories has announced that data from a pilot study investigating
the effects of hormone supplementation following clomiphene citrate therapy
has been published in the July issue of Current Medical Research and Opinion.
Boston Scientific has completed enrollment in the transitional phase of what
the company claims will be the world's largest drug-eluting stent registry.
Gilead Sciences has begun enrolling patients in a Phase I/II study of the company's
oral HIV integrase inhibitor, GS 9137 for the treatment of HIV.
This double-blind, randomized, placebo-controlled Phase I/II dose-escalation
study will evaluate the tolerability, safety and antiviral activity of GS 9137
in HIV-positive patients.
Acadia has reported results from a planned interim trend analysis of its ongoing
multicenter Phase II clinical trial of ACP-103 for treatment-induced psychosis
in patients with Parkinson's disease.
Spectrum Pharmaceuticals has received approval from the FDA's Office of Generic
Drugs for its abbreviated new drug application for carboplatin injection in
50-, 150- and 450-mg multi-dose vials.