Protagonist Therapeutics Inc. added a new investor, Pharmstandard International SA, to its previously announced Series B financing, boosting its raise by $4 million, for a total of $18 million. The funds will support Protagonist’s pipeline of orally stable peptides for inflammatory bowel disease (IBD) and other gastrointestinal (GI) disorders.
Sangamo Biosciences Inc. will collect about $65 million in gross proceeds from a public offering of 6. 1 million shares of common stock in an underwritten public offering. The company will funnel the money into continued research and development of its engineered zinc finger DNA-binding proteins (ZFP).
Regado Biosciences Inc., of Basking Ridge, N.J., enrolled its first patient in the Phase III REGULATE-PCI trial of its antithrombotic drug, REG1, in patients undergoing percutaneous coronary intervention (PCI).
Following its dramatic primary endpoint miss in February, Celsion Corp.’s HEAT study offers some hope in a post-hoc analysis including positive overall survival results in a subgroup of participants.
Galena Biopharma Inc. priced an underwritten public offering of 17.5 million units of stock at $2 per unit, for gross proceeds of $35 million. The funds will be used for commercialization of Abstral (fentanyl) sublingual tablets, and to support an ongoing Phase III trial of Neuvax.
The FDA’s Oncologic Drugs Advisory Committee voted 13 - 1 Thursday to support approval of Genentech Inc.’s supplemental biologics license application for Perjeta (pertuzumab) in neoadjuvant (preoperative) treatment of breast cancer. The application is the first for a neoadjuvant indication.
Prometic Life Sciences Inc., of Laval, Quebec, will earmark a portion of the proceeds from a $10 million financing from Thomvest Seed Capital Inc. to commission its GMP facility for manufacture of plasma-derived orphan drugs.
What if a child were playing on the train tracks? What if there were a nuclear accident on the coastline? What if a safe were falling from the sky? The Pediatric Ethics Subcommittee of the FDA spent a second day of meetings deliberating on the questions posed by the agency, informed by speaker presentations from the previous day.
The Pediatric Ethics Subcommittee of the Pediatric Advisory Committee convened Monday morning for a two-day meeting to hammer out the difficult ethical issues related to development of pediatric medical countermeasures (MCM).
The FDA released briefing documents for Glaxosmithkline plc’s Anoro Ellipta (umeclidinium/vilanterol) inhaler product for chronic obstructive pulmonary disease (COPD) ahead of a scheduled advisory committee meeting on Sept. 10. The outlook for Anoro Ellipta appears to be smooth sailing, as the FDA’s clinical review found little to criticize in GSK’s submission.
