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" »
Roche/Genentech’s Avastin takes another step forward toward an indication in ovarian cancer with the July 2 release of positive topline results from a second Phase III study showing an undisclosed benefit for progression free survival.
Continue reading "Coming In Monday's "The Pink Sheet" DAILY -- Avastin Moves Toward Ovarian Cancer Indication" »
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