Cladribine is back in the running to be the first oral multiple sclerosis therapy to market. EMD Serono, the U.S. affiliate of Merck KGaA, announced that FDA has accepted a refiling of the NDA it rejected in Novmeber and given it a priority six-month review with an action date in the fourth quarter. Competitor Biogen Idec's candidate Gilena has an action date in September.
Continue reading "Coming In Thursday's "The Pink Sheet" DAILY -- FDA Accepts NDA for Multiple Sclerosis Drug Cladribine, Among Other Stories" »
Providing the details of a risk management strategy would aid sponsors in their quest for a positive response to weight-loss drugs from FDA's Endocrinologic and Metabolic Drugs Advisory Committee, the panel indicated July 15 in its review of Vivus's Qnexa.
Continue reading "REMS For Obesity Drugs May Need More Specifics After Qnexa Advisory Panel" »
Viiv Healthcare, the venture launched last year by GlaxoSmithKline and Pfizer to combine their HIV/AIDS portfolios, will make the intellectual property for the entire portfolio available to generic drug makers in 60 low-income countries. The initiative potentially will make generic versions of drugs like Pfizer's Selzentry (maraviroc) available to 80 percent of all people currently living with HIV.
Continue reading "Coming In Monday's "The Pink Sheet" DAILY - Viiv Healthcare To Share Its IP With Generic Makers" »
Vivus proposes a Risk Evaluation and Mitigation Strategy for its obesity drug Qnexa, including a voluntary pregnancy registry, to address potential safety issues that will be discussed at a July 15 advisory committee meeting.
Continue reading "Coming In Wednesday's "The Pink Sheet" DAILY - Vivus Offers REMS For Obesity Drug Qnexa " »
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