Unlike any other theory in drug development, the amyloid hypothesis of Alzheimer’s disease has maintained an almost cult-like following, despite two decades littered with a long line of late-stage failures and not a single success....

Serkan Kutan started in January as the CTO of the healthcare venture from J.P. Morgan (NYSE:JPM), Berkshire Hathaway Inc. (NYSE:BRK-A; NYSE:BRK-B) and Amazon.com Inc. (NASDAQ:AMZN). He was CTO of Zocdoc Inc. (New York, N.Y.), a...

A joint FDA advisory panel voted 19-2, with one abstention, that gout drug Uloric febuxostat has a favorable benefit-risk profile for some patient populations. The U.S. business unit of Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) markets...

Gossamer Bio Inc. (San Diego, Calif.) plans to raise up to $264.5 million in an IPO on NASDAQ, according to a Dec. 21 SEC filing. The company was launched by ex-Receptos Inc. executives in January...

EMA's CHMP released a handful of negative opinions July 27, including one for Blincyto blinatumomab from Amgen Inc. (NASDAQ:AMGN) and, on re-examination, negative recommendations for Dexxience betrixaban from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) and Eladynos abaloparatide-SC...

EMA's CHMP recommended against approval of Radius' Eladynos abaloparatide-SC to treat osteoporosis in postmenopausal women at increased risk for fracture. Radius said it plans to request a re-examination. Abaloparatide-SC is a subcutaneous peptide analog of...

Merck & Co. Inc. (NYSE:MRK) stopped the double-blind, international Phase III APECS trial of verubecestat (MK-8931) to treat prodromal Alzheimer’s disease after an external DMC said it was unlikely the trial would establish a positive...

Merck & Co. Inc. (NYSE:MRK) stopped the Phase III APECS trial of verubecestat (MK-8931) to treat prodromal Alzheimer’s disease after an external DMC said it was unlikely the trial would establish a positive benefit-risk profile...

Gene editing company CRISPR Therapeutics AG (NASDAQ:CRSP) said CSO Bill Lundberg is stepping down. He will become head of CRISPR's scientific advisory board. RNA therapeutics company Arcturus Therapeutics Ltd. (NASDAQ:ARCT) said President and CEO Joseph...

Ipsen Group (Euronext:IPN; Pink:IPSEY) said FDA approved Somatuline Depot lanreotide acetate (ITM-014) to treat carcinoid syndrome. The extended-release formulation of somatostatin analog lanreotide is already approved in the U.S. to treat acromegaly and gastroenteropancreatic neuroendocrine...