BARCELONA, Spain – What may well be Europe's least known cell therapy company has just begun a phase III trial of its lead program in a notoriously challenging indication. Rexgenero Ltd. began recruiting diabetic patients with critical limb ischemia (CLI) last week, CEO Joe Dupere told BioWorld Today. He expects the first patient to receive treatment by the end of this month. Read More
The advent of checkpoint inhibitors yielded a big win for the burgeoning immuno-oncology space, supercharging activated T cells to attack cancer cells, and the success with drugs targeting CTLA-4 and PD-1 has translated into efforts chasing other checkpoint mechanisms, all in the hopes of expanding the stunning results into broader patient populations. Read More
No political tantrums upstaged the importance of passing PDUFA VI in a timely manner when a House subcommittee met Wednesday to discuss the user fee agreement that the FDA, industry and patient groups have negotiated over the past two years. Read More
SINGAPORE – Asia's rapidly developing health care ecosystem should ease market access for pharmaceutical companies and drug access for patients, but communication and transparency remain a key challenge hindering development. Unless all stakeholders in the sector come together, drug costs will remain high, industry experts said at the BioPharma Asia Convention here. Read More
Vital Therapies Inc., of San Diego, which is developing Elad, a cell-based therapy targeting the treatment of acute forms of liver failure, said it priced an underwritten public offering of 8.75 million newly issued shares of its common stock at $4 per share for gross proceeds of approximately $35 million. Read More
Opko Pharmaceuticals LLC, of Miami, gained FDA orphan status for oligonucleotide-based Antagonat (CUR-1916) for the treatment of Dravet syndrome. The Antagonat technology, part of Curna Pharmaceuticals, acquired by Opko in 2011 for $10 million. It was further developed in Opko's Miami research laboratories. (See BioWorld Today, Feb. 2, 2011.) Read More
Aveo Oncology Inc., of Cambridge, Mass., said the first patient has been dosed in the phase I/II Aveo-sponsored TiNivo trial evaluating tivozanib in combination with New York-based Bristol-Myers Squibb Co.'s anti-PD-1 therapy, Opdivo (nivolumab), in advanced renal cell carcinoma. Tivozanib is an oral, once-daily, vascular endothelial growth factor tyrosine kinase inhibitor. Read More
GW Pharmaceuticals plc, of London, appointed Scott Giacobello chief financial officer, and Adam George managing director – UK. Giacobello will be based at the company's U.S. headquarters in Carlsbad, Calif. Read More
