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An FDA advisory panel is recommending against approval of Actavis’ NDA for a fixed-dose combination of nebivolol and valsartan to treat hypertension. Read More
The FDA has cleared Takeda and Orexigen Therapeutics’ weight-loss drug Contrave, the first new anti-obesity product to win approval in more than two years. Read More
Taiwan-based TWi Pharmaceuticals has won final FDA approval for a generic version of Par Pharmaceutical’s AIDS drug Megace ES, but the product’s launch remains on hold as the brandmaker appeals its 2011 patent infringement lawsuit. Read More
Australia’s Therapeutic Goods Administration (TGA) will aim to make a decision on an orphan drug designation request within 20 working days of receipt of the application. Read More
The UK’s cost-effectiveness watchdog is recommending against coverage of Celgene’s cancer drug Ambraxane with gemcitabine for patients with previously untreated metastatic pancreatic cancer, citing its expensive price and limited benefits compared with current treatments. Read More
The European Commission has approved a new indication for Roche’s rheumatoid arthritis drug RoActemra to treat patients in the early phase of the disease. Read More
Connecticut’s Attorney General has joined a growing chorus of voices urging the FDA to immediately approve a generic version of AstraZeneca’s acid-reflux drug Nexium, either by clearing first-filer Ranbaxy’s version or by finding that the Indian firm forfeited its exclusivity because of rampant delays. Read More
CDER Director Janet Woodcock is calling on industry to collaborate in the development and verification of new biomarkers, which the agency says can improve clinical trial efficiency but so far have been underused. Read More
Keryx Biopharmaceuticals said it will launch its renal disease drug ferric citrate within 12 weeks, following FDA approval Friday of the product that controls phosphorus levels in dialyzed chronic kidney disease (CKD) patients. Read More