Takeda Heartburn Drug Encounters Delay At U.S. FDA
This article was originally published in PharmAsia News
A heartburn drug of Takeda's U.S. arm has encountered a snag in its effort to gain approval by the U.S. FDA. The agency notified Takeda Pharmaceuticals of North America it would not be able to complete a review as expected by the end of October. At issue is the TAK-390MR proton pump inhibitor intended for treating gastroesophageal reflux disease and other serious acid-related problems. The agency told Takeda it would need another three months to review all the data supplied by Takeda. A spokesman said Takeda's drug has elements that differ from existing proton pump inhibitors. (Click here for more
You may also be interested in...
Denmark’s biotech Genmab has dropped the AXL targeted antibody-drug conjugate, enapotamab vedotin from early clinical development, and is focusing its resources on other therapeutic programs.
Potentially transformative treatments for severe asthma, COPD and osteoarthritis are among some of the below-the-radar projects the Swiss major is advancing, according to Vas Narasimhan.
Pharma’s latest partnerships focus on Duchenne muscular dystrophy with Precision Biosciences, protein degradation with Seed. Bristol and Schrodinger team in computational drug discovery.