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The FDA slapped Blue Ridge Pharmacy and Compounding Center with a warning letter for compounding products without a prescription and poor conditions for aseptic processing, another sign that the agency doesn’t plan to let up on large compounders. Read More
UK drug giant GlaxoSmithKline said Tuesday that its investigational coronary drug darapladib failed to reduce cardiovascular events in patients experiencing symptoms of obstructed blood flow to the heart, marking another setback for the once promising therapy. Read More
Canadian drug regulators have temporarily banned Biolyse Pharma from making and selling its cancer-fighting agent paclitaxel after a series of inspections at the firm’s St. Catharines, Ontario, facility uncovered serious manufacturing problems. Read More
Shire Pharmaceuticals said it will acquire Lumena Pharmaceuticals for at least $265 million, making it the latest drugmaker to turn to new treatments for rare diseases as a means to offset losses from generic competition. Read More
The FDA plans to begin sharing more quality inspection data with its European counterparts so that regulators on both sides of the Atlantic can direct their resources on the riskiest companies. Read More
The FDA has been quicker to approve new active substances over the last decade than both its European and Japanese counterparts, a recent study finds. Read More
British health-payment authorities reversed course last week and cleared the way for the use of Astellas Pharma’s advanced prostate cancer drug Xtandi in men who already had been treated with Johnson & Johnson’s competitor product Zytiga. Read More
Sun Pharma is in the midst of another quality problem, this time involving a massive recall of 428,058 bottles of antihistamines and antidepressants after stability testing found issues with the products. Read More
Teva is making a last-second attempt to delay generic versions of its multiple sclerosis drug Copaxone from hitting the market, asking a federal court to require ANDA seekers to submit more data. Read More