BOSTON, Mass. – KRAS used to be the poster child for undruggability. No more. Amgen Inc. and Mirati Therapeutics Inc. are in the clinic with KRAS inhibitors. Boehringer Ingelheim GmbH is planning to join them by the end of the year. And multiple other companies are moving programs forward. Read More
Amag Pharmaceuticals Inc.'s argument for keeping Makena on the market without having to conduct a new trial went nowhere Tuesday as an advisory committee struggled with conflicting efficacy data for the preterm birth drug that received accelerated approval eight years ago. Read More
An already validated approach with Navidea Biopharmaceuticals Inc.'s radioimaging agent for rheumatoid arthritis (RA) might have presaged the victory, but that didn't stop Wall Street from rewarding the shares handsomely, and the stock (NYSE:NAVB) closed Tuesday at $1.10, up 32 cents or almost 41.5%, having traded as high as $1.36. Read More
Brian MacDonald's pursuit of an approved hepcidin therapy at Merganser Biotech Inc. didn't quite pan out, but that didn't stop him from taking up Atlas Venture's offer to try it once again on a different tack. Read More
LONDON – The U.K. government told the industry to maintain its readiness for a no-deal Brexit Tuesday, as it was forced to ask the EU for another extension after failing to get a revised withdrawal bill through Parliament. Read More
BEIJING – Shanghai-based Visen Pharmaceuticals is pushing its long-acting growth hormone therapy, which is also the first of its kind in China, one step closer to the NDA-stage after receiving clearance from Chinese regulators this week to start a phase III trial. Read More
HONG KONG – South Korean startup Rznomics Inc. has recently secured ₩12 billion (US$10 million) in a series A investment. The Gwangju-based company focuses on cancer treatment development based on RNA platform technology. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations. Read More
