A consortium of some of China's biggest health care players is snapping up trans-Pacific protein therapeutics developer Ambrx Inc. for an undisclosed amount in a bid to accelerate the introduction of innovative, and presumably more profitable, therapies to the Chinese market.
Sarepta Therapeutics Inc. shares rose more than 60 percent to $26.24 on Wednesday after the company said it would start a rolling submission of its new drug application (NDA) for the Duchenne muscular dystrophy (DMD) drug eteplirsen.
Following extensive talks with the FDA and European regulators, Intercept Pharmaceuticals Inc. has nailed down plans for a rigorous pivotal phase III study testing obeticholic acid (OCA), the company's lead candidate, in about 2,500 patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis, a population representing potentially more than 14 million patients in the U.S. alone.
Eleven Biotherapeutics Inc.'s lead candidate EBI-005 failed to outperform a vehicle control in a phase III study of moderate to severe dry eye disease, driving company shares (NASDAQ:EBIO) down 69.2 percent to $3.69 on Monday.
Angion Biomedica Corp. plans to soon begin enrolling a phase III study of BB3, an organ-protecting regenerative treatment it is testing in kidney transplant recipients with delayed graft function (DGF), a situation in which the organ fails to function properly, pushing patients onto dialysis after surgery.
Sanofi SA is expanding its work with Selecta Biosciences Inc., exercising a multi-million dollar option to license Selecta's antigen-specific immunotherapy platform to underpin a research-stage program targeting the severe gluten allergy celiac disease.
SAN FRANCISCO – With international dealmaking often a key element of the biopharma asset development adventure, the path to success in Japan took center stage during the first day of Allicense, an annual pilgrimage for the industry's top business development pros.
Axovant Sciences Ltd., a small Bermuda-based company formed in October to carry a phase-III-ready asset bought from Glaxosmithkline plc through approval in Alzheimer's disease (AD), has filed for an IPO of up to $172.5 million.
With rising royalty revenue boosting its first quarter earnings, Ligand Pharmaceuticals Inc. added rights to potential future milestone and royalty payments on 15 biologic development programs from its existing partner, Selexis SA, for $4 million in cash.
