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The FDA has delayed BioMarin’s plans to market drisapersen, the company’s Duchenne muscular dystrophy candidate, with a complete response letter calling for more evidence of the therapy’s benefits. Read More
Indian analysts attribute ongoing quality control issues with pharmaceutical exports to a dearth of pharmaceutical inspectors and a lack of uniform standards in the country. Read More
Roche has settled its legal feud over Tarceva with Glenmark Pharmaceuticals, with both sides agreeing to drop lawsuits over patent rights in India. Read More
Drugmakers that have not started complying with worldwide track and trace regulations are behind the curve, as most countries only allow for two to three years for implementation, a supply chain expert cautions. Read More
The FDA is asking India-based Sun Pharmaceuticals to conduct tests and turn over reams of paperwork in response to a warning letter alleging more than a dozen cGMP violations. Read More
The FDA again has slapped India’s Cadila Pharmaceuticals with a warning letter, this time alleging GMP violations — including a lack of quality controls, improper recordkeeping and inadequate investigations — at its Moraiya formulation plant and Ahmedabad API facility. Read More
A number of drugmakers got good news from the European Medicines Agency’s Committee for Medicinal Products for Human Use, including two companies looking to have their lung cancer drugs approved in Europe. Read More
A journal article asking the FDA to defy its own policies concerning drug reimportation and mass compounding to combat rising drug prices comes from an unusual source: the agency’s former second-in-command. Read More
Takeda Pharmaceuticals is selling off some of its drugs in Japan in exchange for stock in a new venture to be helmed by Teva Pharmaceutical Industries. Read More