DUBLIN – The market decided that Radius Health Inc. was the big winner when Amgen Inc. and UCB SA unveiled their long-awaited phase III data for romosozumab (AMG785, CDP7851) on reducing the risk of fracture in osteoporosis. Read More
Braeburn Pharmaceuticals Inc., of Princeton, N.J., and Camurus AB, of Lund, Sweden, said the first patients were dosed with CAM2038, weekly and monthly subcutaneous buprenorphine injections, in a pharmacokinetic study of opioid-dependent patients with chronic pain. The primary objective of the phase II study is to assess the steady state pharmacokinetics of buprenorphine after repeated doses, including effects of injection into different subcutaneous sites. The study will also explore the effect of CAM2038 on chronic pain, along with evaluation of safety and tolerability. Read More
Chimerix Inc. CEO Michelle Berrey assured investors of "some ways for us to skin this cat a little more quickly," as the company probes the intriguing efficacy of brincidofovir – often shorthanded to "brinci" – against BK virus, although Wall Street meanwhile clipped shares on word that two phase III trials with the oral nucleotide analog in kidney transplant are stopping. Read More
Mesoblast Ltd., the developer of a cell therapy for steroid-refractory acute graft-vs.-host disease (GVHD), reported that a new analysis of long-term data shows that children treated with the cells demonstrated clinically meaningful responses and significantly increased survival, with an overall response rate of 65 percent at 28 days after treatment. Read More
A joint statement issued by Massachusetts Gov. Charlie Baker, chair of the National Governors Association's (NGA) Health and Human Services Committee, along with New Hampshire Gov. Maggie Hassan, the committee's vice chair, and Patrice Harris, chair-elect of the American Medical Association (AMA), placed another thorn in the side of the FDA a day after Titan Pharmaceuticals Inc. and partner Braeburn Pharmaceuticals Inc. disclosed that the agency extended by three months the PDUFA date for Probuphine, designed for the maintenance treatment of opioid addiction. Read More
Amarantus Bioscience Holdings Inc., of San Francisco, said it closed a $3 million investment from an institutional investor who will be issued series H convertible preferred stock valued at $3.3 million (including 10 percent original issue discount) and five-year warrants exercisable for 13.2 million shares of common stock at $0.40 each. Read More
Vtv Therapeutics Inc., of High Point, N.C., said data from research on its small-molecule GLP-1R agonist were presented during the Keystone Symposium, being held this week in Keystone, Colo. "TTP273: Oral, G-protein Pathway Selective, Clinical-Stage GLP-1 Receptor (GLP-1R) Agonist" demonstrated that TTP273, an allosteric standalone agonist, indicated "functional selectivity" for a subset of the full GPCR signaling repertoire. Read More