Bristol-Myers Squibb Co.'s (BMS) chief scientific officer (CSO), Thomas Lynch, said the firm has not seen any overall survival (OS) data from the phase III Checkmate-227 study, and called the progression-free survival (PFS) data "very fresh to us. We look forward to reporting those at an important medical meeting," and will publish the results in a scientific journal "as soon as we possibly can," he said. Read More
The FDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Monday issued a data standards strategy for fiscal 2018 through 2022. Read More
Trethera Corp., of Los Angeles, said the FDA cleared its IND for TRE-515, an inhibitor of deoxycytidine kinase, for the treatment of myelodysplastic syndromes (MDS). Read More
Capricor Therapeutics Inc., of Los Angeles, said the FDA granted CAP-1002, its lead investigational cell therapy for the treatment of Duchenne muscular dystrophy (DMD), the regenerative medicine advanced therapy designation. CAP-1002 consists of allogeneic cardiosphere-derived cells. Read More
Top-line results from Eyegate Pharmaceuticals Inc.'s phase IIb study of combination drug/device candidate EGP-437 to treat pain and inflammation in patients following cataract surgery hit a familiar stumbling block. Read More
The first of two phase III trials seeking to prove Spectrum Pharmaceuticals Inc.'s Rolontis (eflapegrastim) noninferior to Neulasta (pegfilgrastim) for chemotherapy-induced neutropenia management achieved that goal, validating the company's decision to license the drug from Hanmi Pharmaceutical Co. Ltd. in 2014. Read More
LONDON – Cambridge, U.K.-based Acacia Pharma Group announced it is to list on Euronext Brussels, two years after uncertain market conditions forced it to call off an IPO on the London Stock Exchange (LSE). Read More
LONDON – Newco Balmes Transplantation SAS added a further €700,000 (US$872,000) to its initial €900,000 seed funding, providing the means to reach proof of concept in animal models of kidney damage caused by ischemia reperfusion injury (IRI) following transplantation and also in IRI associated with cardiac surgery. Read More
HONG KONG – An 11-year-old Chinese biopharma company has recently entered the public's eye with a $10 million series A funding and a clinical trial approval by the CFDA for its biosimilar etanercept. Read More
Silver Creek Pharmaceuticals Inc., of San Francisco, said it completed up to $20 million in financing, with $9 million being funded in a first tranche and the remainder becoming available on the achievement of specific milestones. Read More
