Opexa Therapeutics Inc., of The Woodlands, Texas, said it filed a registration statement with the SEC for a proposed rights offering of subscription rights to purchase units comprised of a share of Opexa common stock and warrants to purchase an additional share of common stock. Read More
Biomay AG, of Vienna, said a landmark phase IIb study has been successfully completed with its third-generation grass pollen allergy vaccine BM32. In this placebo-controlled, double-blind, prospective study, 181 patients were included and initially received either of two doses of BM32 or the matching placebo. Read More
Amgen Inc., of Thousand Oaks, Calif., and its subsidiary Onyx Pharmaceuticals Inc. submitted a supplemental new drug application (sNDA) to the FDA and a marketing authorization application (MAA) to the EMA seeking approval to market the proteasome inhibitor Kyprolis (carfilzomib) for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. Read More
It's been more than six years since 2007 start-up Vaccinogen Inc. licensed rights to Oncovax, a cancer vaccine set to start a confirmatory phase III study in colon cancer. During that time, the immunotherapy space saw more than its share of highs and lows – the excitement surrounding the approval of Dendreon Corp.'s prostate cancer vaccine Provenge (sipuleucel-T) subsequently crushed by discouraging sales, followed by immunotherapy wins with Bristol-Myers Squibb Co.'s Yervoy (ipilimumab) and the new PD-1 checkpoint inhibitors. Read More
The conversation has started on the 21st Century Cures discussion draft released Tuesday, with much of it focused on the one thing left out of the nearly 400-page outline of proposals – more funding for the National Institutes of Health (NIH). Read More
Initial data from a phase I trial of Glaxosmithkline (GSK) plc's Ebola virus vaccine were published on Wednesday, showing the product is safe and immunogenic. The results were released as the first shipment of the vaccine reached one of the countries hit by the epidemic, with 300 vials arriving in Liberia, West Africa. Read More
NEW DELHI, India – The EMA has recommended suspending the Hyderbad-based contract research organisation (CRO) GVK Biosciences on charges of data manipulation, a decision that once again shines a spotlight on the issue of Western drug firms outsourcing clinical trials to CROs to cut costs. Read More
Mustering hope in the obesity space – marked by drugs' generally disappointing sales despite a large and growing market – is tough, but Boston-based Zafgen Inc. recently drew investor enthusiasm and pulled off a $138 million public offering to advance what RBC Capital Markets analyst Simos Simeonidis called "a really impressive drug." Read More
