Ranbaxy Laboratories said it has signed a consent decree with FDA and set aside $500 million to settle a related Department of Justice investigation involving GMP violations and data integrity issues at its Indian facilities.
Ranbaxy Laboratories Ltd.’s announcement that it has entered into a consent decree with FDA and set aside $500 million to settle a related Department of Justice investigation appears to put the Daiichi Sankyo Co. Ltd. subsidiary on pace to pay the second highest settlement for pharmaceutical good manufacturing practice violations.
Ranbaxy would join Schering-Plough Corp
Japan's trade ministry is providing new support to build domestic capacity for new modalities including cell and gene therapies, as part of wider efforts to support the national bioventure ecosystem.
US-based Colossal Labs has claimed to bring back the dire wolf from extinction. While the science is not as dramatic in India yet, cell and gene therapies are making progress as treatments for cancer and other diseases. Pink Sheet takes a look at what is driving CGT success and growth.
Artesunate for malaria, TB drug pretomanid and omadacycline for pneumonia and skin infections are among the drugs identified by Japanese regulatory authorities in urgent need of domestic development.
