Axsome Therapeutics said on April 25 the company expects the U.S. health regulator to decline approval for the drug developer’s treatment of acute migraine over unresolved issues of its quality control processes, sending shares of Axsome down 20 percent.

The U.S. Food and Drug Administration issued a warning letter to Fresenius Kabi AG of Germany for its plant in India.

India said it is revising its drugs law to make it easier for companies to do business while ensuring the safety and efficacy of medicines, in Prime Minister Narendra Modi’s latest move to encourage industry. Until last year, India was trying to tweak its archaic Drugs and Cosmetics Act of 1940, and an amendment bill […]

Signage for GlaxoSmithKline is seen on it’s offices in London, Britain, March 30, 2016. Reuters/Toby Melville/File Photo Manufacturing problems at a factory in Italy have disrupted production of some GlaxoSmithKline medicines, leading to shortages of a commonly used opioid anaesthetic in Denmark. The British drugmaker said on Friday it had temporarily suspended manufacturing at its […]

Drugmaker IPCA Laboratories Ltd said the U.S. Food and Drug Administration issued it a warning letter outlining manufacturing quality lapses observed at three of its Indian factories, pushing its shares down as much as 16 percent. The letter concerns the company’s finished-drug plants at Piparia in western India, and Indore in central India, as well […]

Dr Reddy’s Laboratories Ltd, India’s second-largest drugmaker by sales, said on Tuesday it had been temporarily barred by a U.S. court from selling its generic form of blockbuster heartburn drug Nexium in the United States. The order was passed by the U.S. district court of Delaware after AstraZeneca, the maker of Nexium, moved a motion […]

Dr Reddy’s Laboratories Ltd, India’s second-largest drugmaker by sales, received a warning letter from the U.S. Food and Drug Administration over inadequate quality control procedures at three manufacturing plants in India. Dr Reddy’s shares fell as much as 12 percent in early trade to their lowest level since July 30. The warning letter was issued […]

The U.S. Food and Drug Administration has revoked an approval issued in March to India’s Sun Pharma Advanced Research Company Ltd (SPARC) to launch a drug for seizures, citing manufacturing quality problems at its production site. The move comes as a setback to SPARC, the research arm of India’s largest drugmaker, Sun Pharmaceutical Industries Ltd. […]

The U.S. Food and Drug Administration (FDA) has banned imports from another India-based drug manufacturing plant over quality control concerns, making it the 10th site in the country this year to face such action.   The FDA’s “import alert” on Mumbai-based Polydrug Laboratories Pvt Ltd’s Ambernath manufacturing plant comes two months after Canada banned the […]