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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
European and U.S. regulators have made strides towards mutual recognition of quality inspections so that companies being inspected by one regulator would not have to face an inspection by the other, but setbacks still remain, a top European regulatory official said. Read More
Injectable drug maker Hospira has issued a voluntary recall of dobutamine injection, USP, after a customer complaint of discoloration in a single vial of the heart disease drug. Read More
The FDA’s proposal to give generic manufacturers the same labelling authority as brand manufacturers is nothing short of “illegal,” argue two prominent FDA observers. Read More
Generic manufacturers are unlikely to be pleased with final draft guidance from the FDA on ANDA stability testing that continues to insist on six months of long-term stability data. Read More
Manufacturers of biosimilars should take great care in designing clinical trials and other steps needed to demonstrate exactly how their products line up with the reference drugs, according to key FDA draft guidance on creating versions of the complex therapies. 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
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