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Generic manufacturers are unlikely to be pleased with final draft guidance from the FDA on ANDA stability testing that continues to insist on six months of long-term stability data.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
Two Johnson & Johnson divisions have sued generic firm Mylan over its bid to market a version of the attention deficit hyperactivity disorder drug Concerta. Read More
The National Institute for Health and Care Excellence says the UK government should not reimburse for Johnson & Johnson’s prostate cancer drug Zytiga because it is not cost effective. Read More
An FDA study of postmarket reports shows that Boehringer Ingelheim’s blood thinner Pradaxa presents an increased risk of major gastrointestinal bleeding but a lower risk of strokes and deaths compared with warfarin. 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and other steps needed to demonstrate exactly how their products line up with the reference drugs, according to key FDA draft guidance on creating versions of the complex therapies.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
Specialty pharmaceutical firm Actavis has reached a deal to market generic versions of Valeant Pharmaceuticals’ acne-treating Acanya Gel, as well as its hypertension drug Tiazac, under a patent settlement agreement announced Monday. Read More
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