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" »
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 " »
FDA drug reviewers indicate they are split on the safety of Avandia in GlaxoSmithKline’s RECORD study. Their views are included in briefing documents made available prior to the advisory committee meeting on July 13.
Continue reading "Coming in Monday's "The Pink Sheet" DAILY - FDA Divided On Avandia Safety In RECORD Study" »
While NycoMed’s COPD drug Daxas is tied up in regulatory delays in the US, the European Union has granted marketing authorization for its use as maintenance therapy in severe COPD patients with a history of frequent exacerbations as an add-on to bronchodilators. Merck has rights to co-promote the drug in some of the largest EU markets, including Germany and France, and a distribution deal in the U.K.
Continue reading "Coming in Wednesday's "The Pink Sheet" DAILY - NycoMed's Daxas Approved In Europe" »
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