India's Aurobindo Pharma has submitted an abbreviated new drug application (ANDA) to the FDA for the treatment of HIV as part of the country's pharmaceutical industry's efforts to ramp up production of drugs to treat HIV/AIDS.
The European Medicines Agency has affirmed its January recommendation, calling for the suspension of more than 700 products tied to improprieties at a GVK Biosciences facility in India.
The European Medicines Agency is standing by its original recommendation made earlier this year to suspend a number of medicines that received European Union clearance based on clinical studies conducted by GVK Biosciences in India.
Cipla announced a drug recall of its asthma inhalant levalbuterol from the U.S. market following an FDA warning, and Wockhardt withdrew about a dozen drugs on manufacturing concerns at two of its plants in India.
Medtronic CEO Omar Ishrak has long turned to emerging markets as a potential growth driver, and tapping into India's burgeoning population will play a key role in ramping up the company's business there, he said.
The Indian government is developing a system of medical device surveillance and adverse event reporting, dubbed the Materio-vigilance Programme of India.
In a deal spanning three continents, Asia's Strides Arcolab is paying nearly $300 million for the Australian generics business of Africa's Aspen Pharmacare Holdings. The deal also includes some branded drugs.
Cipla and Wockhardt each announced drug recalls from the U.S. market, the former because of failure to meet specifications, the latter because of U.S. FDA concerns about two of its India plants. A Japan devicemaker also announced a U.S. recall.
With ambitious plans for the next year, Ahmedabad-based Zydus Cadila's coming launches could alter the vaccines landscape in India and challenge established players there.
China and Russia have become new targets for compulsory-licensing campaigns as an activist group widens its global challenge to Gilead's expensive Sovaldi (sofosbuvir) hepatitis C drug.