LONDON – Shield Therapeutics Ltd. reported positive data from the pivotal Phase III trial of ST10, an oral ferric iron replacement therapy, saying the results demonstrate the product could replace the need to administer intravenous iron in patients with anemia caused by inflammatory bowel disease (IBD). Read More
Linda Marban, CEO of Capricor Therapeutics Inc. called a new collaboration between Capricor and Janssen Biotech Inc. a “potentially game-changing validation” of the company’s technology – an allogeneic adult stem cell therapy for heart disease. Read More
Genetic profiling company 23andme Inc., facing a stern letter from the FDA and a separate lawsuit that describes the saliva-derived data as “meaningless,” will not provide health information to new customers until the regulatory matter is handled. Read More
The FTC is set to butt into the biosimilar debate next month with a workshop on the potential competitive impacts of proposed naming schemes and state regulations. Read More
Investors continue to be pleased with the progress of Oxygen Biotherapeutics Inc.’s newly acquired cardiovascular drug, levosimendan, sending shares of the Morrisville, N.C.-based firm up more than 20 percent Monday on news that the protocol for the planned Phase III study of the calcium sensitizer had been published on Clinicaltrials.gov. Read More
LONDON – The New Year has ushered in a new regime for clinical trials data transparency, with the industry getting in just ahead of the regulators, to set up an access system over which it has control – for the time being at least. Read More
LONDON – A candidate vaccine to protect against tuberculosis can protect mice against the disease at least as well as the current vaccine in use, the live bacillus Calmette-Guérin (BCG). Read More
Ignyta Inc., of San Diego, said Silicon Valley Bank increased its support through a new and expanded $10 million capital term loan facility, which replaces a previous $1.5 million facility entered into in June 2012 and February 2013. Read More
Brainstorm Cell Therapeutics Inc., of New York, said a case report on a patient treated with its Nurown cell therapy is slated for publication in Muscle & Nerve. Read More
Generex Biotechnology Corp., of Worcester, Mass., locked its database for the primary efficacy analysis of its ongoing AE37 breast cancer vaccine trial. Read More
Eisai Inc., of Woodcliff Lake, N.J. said Halaven (eribulin) has received reimbursement approval in the Czech Republic for patients with metastatic breast cancer, effective Jan. 1. Read More
