Cerecor Inc. shares (NASDAQ:CERC) lost more than half their value Wednesday after the company reported that its fast-acting antidepressant candidate, CERC-301, failed to help patients with moderate to severe depression see significant improvement, as measured by a scale sensitive to rapid-acting drugs for the condition.
About a year after the outlook for speedy U.S. approval of Fabry disease drug migalastat turned from sunny to sober on FDA feedback, Amicus Therapeutics Inc. said new talks with the agency yielded a path to full approval built on gathering new gastrointestinal (GI) data in a study that won’t read out until 2019, likely pushing potential approval out to 2020.
Global enrollment is complete in the first of two pivotal trials that will back 2018 regulatory filings for the experimental oral peanut allergy treatment AR101, developed by Aimmune Therapeutics Inc. Top-line data from PALISADE, the first phase III study, is expected in the fourth quarter of 2017.
Two cases of cerebral edema, both ending in death, led Juno Therapeutics Inc. to put a clinical hold on a phase II trial of its chimeric antigen receptor (CAR) T-cell therapy, JCAR015, for the second time in five months.
Spectrum Pharmaceuticals Inc. drew an FDA complete response letter (CRL) for its experimental bladder cancer treatment, Qapzola (apaziquone), Friday, three weeks ahead of a scheduled PDUFA date.
Celgene Corp., a long-time backer of privately held Triphase Accelerator Corp., has acquired the company's ocean-sourced proteasome inhibitor, marizomib, currently in development for the I.V. treatment of glioblastoma and relapsed/refractory multiple myeloma, the home territory of Celgene's Revlimid (lenalidomide).
A high dose of the late-stage migraine prevention therapy erenumab (AMG 334), co-developed by Amgen Inc. and Novartis AG, trimmed about two more migraine days than placebo from an average 8.3 monthly migraine days experienced by patients during the last three months of a confirmatory phase III trial. A low dose of the antibody bested placebo by a lesser 1.4 days. Safety was comparable to placebo, Amgen said.
A drug for gastrointestinal troubles shelved during Aryx Therapeutics Inc.'s 2011 demise is back in action at Renexxion LLC propelled by new FDA guidance setting aside the requirement for pre-approval cardiovascular safety outcome studies, the costly prospect of which scuttled the program's advancement at Aryx.
Corbus Pharmaceuticals Holdings Inc. reported that its sole candidate – resunab – added to standard-of-care (SOC) immunosuppressive drugs, out-performed a placebo with SOC during a phase II trial in patients with diffuse cutaneous systemic sclerosis, an autoimmune disorder.
