Elusys Therapeutics Inc.'s injectable anthrax antitoxin, branded Anthim (obiltoxaximab), became the newest member of the elite club of drugs to gain FDA approval through the agency's Animal Rule. Read More
The slip-up on the secondary neurocognitive endpoint in Biomarin Pharmaceutical Inc.'s pivotal phase III PRISM-2 study in phenylketonuria (PKU) with pegvaliase, also known as Peg-Pal, probably matters less than the win with regard to phenylalanine (Phe) levels, analysts figure – and may not have been much of a miss anyway. Read More
Two U.S. agencies have released a draft guidance for a streamlined clinical trial protocol that would apply to phase II and III clinical trials supported by the NIH, but the FDA and the NIH indicated that the provisions may be useful in the context of standards for international drug and medical device trials as well. Read More
Amgen Inc. and its partner UCB SA reported that the sclerostin inhibitor romosozumab met its primary endpoint in a pivotal phase III study, called Bridge, providing men with osteoporosis with a statistically significant increase in bone mineral density (BMD) at the lumbar spine vs. placebo at 12 months. Read More
LONDON – Topas Therapeutics GmbH has raised €14 million (US$15 million) in a series A round to advance a new approach to treating autoimmune diseases by targeting specialized liver cells that are involved in inducing tolerance to blood-borne antigens. Read More
SHANGHAI – Canbridge Life Sciences Ltd., a privately held biopharma in Beijing, has in-licensed AV-203, a clinical-stage ErbB3 (HER3) inhibitory antibody candidate from Aveo Oncology Inc., of Cambridge, Mass. While the candidate has been tested in numerous tumor models, Canbridge will develop AV-203 in esophageal squamous cell cancer (ESCC), the most prevalent form of esophageal cancer especially in China where half of all new cases arise. Read More
Valeant Pharmaceuticals International Inc., of Laval, Quebec, initiated a search to replace CEO J. Michael Pearson but said Pearson will remain in the role and continue to serve as a director in the interim. Read More
Spring Bank Pharmaceuticals Inc., of Milford, Mass., which had planned to raise up to $40 million from an IPO has postponed its offering. The company is developing small-molecule therapies for hepatitis B and viral diseases. Read More
Valneva SE, of Lyon, France, reported that for its full year financial results for the period ending Dec. 31, 2015, total revenues and grants were €83.3 million (US$93.7 million) compared to €42.4 million in 2014. Read More
Leo Pharma A/S, of Ballerup, Denmark, said the EU granted scientific approval for Enstilar (calcipotriol/betamethasone dipropionate 50 mcg/g / 0,5 mg/g), an alcohol-free foam product to treat psoriasis vulgaris for those 18 and older in the EU. The approval was based on data from the phase IIIa PSO-FAST study. Read More
Catabasis Pharmaceuticals Inc., of Cambridge, Mass., reported that all three doses of its experimental Duchenne muscular dystrophy (DMD) drug CAT-1004 tested during the first part of a phase I/II trial were generally well tolerated with no safety signals observed. Read More
