Catalyst Pharmaceuticals Inc. turned the commercial corner with FDA approval, on its PDUFA date, of Firdapse (amifampridine phosphate) 10-mg tablets as the first drug designated in the U.S. to treat adults with Lambert-Eaton myasthenic syndrome (LEMS). Read More
Viacyte Inc., a company developing allogeneic cell replacement therapies for people with diabetes, has raised an $80 million series D financing to support further testing of its regenerative medicine approach. Bain Capital Life Sciences led the round, joined by TPG and RA Capital Management, as well as existing investor Sanderling Ventures and individual investors. Read More
After decades of paying homage to Roche Holding AG's Cabilly patents, makers of recombinant monoclonal antibodies (MAbs) are about to be set free. The last of the Cabillies will expire next month, releasing a who's who list of the biopharma industry – both innovators and biosimilar sponsors – from licensing deals for the patents that have been foundational to MAb development. Read More
Full results are not due until the spring, but investors meanwhile didn't seem much enthused by Dublin-based Alkermes plc's positive top-line results from Enlighten-2, a pivotal phase III study of ALKS-3831 (olanzapine/samidorphan), a once-daily, oral atypical antipsychotic prospect for schizophrenia. Read More
Evidence is mounting that obesity influences the way in which patients respond to cancer immunotherapies, with studies showing the pre-existing state of meta-inflammation caused by being overweight is exacerbated on administration of immunotherapy. Read More
TAIPEI, Taiwan – How to attract capital is a well-trod theme in the biopharma sector, but the best investors bring more than just money to the table, speakers noted during the Asia Pacific Biotech Investment Forum this week. The right kind of business know-how could help turn a company with a good idea and solid research into a unicorn, a startup with a valuation of $1 billion. Read More
C4X Discovery Holdings plc, of Manchester, U.K., and GTN Ltd., of London, are collaborating to discover small-molecule candidates against an undisclosed neurodegeneration target. C4XD will contribute its conformational analysis platform, Conformetrix, and GTN will add its in silico discovery platform. Terms of the deal weren't disclosed. Read More
Renovacare Inc., of Scottsdale, Ariz., disclosed an equity financing of $15.5 million from Kalen Capital Corp., the family office of Harmel S. Rayat, majority shareholder and company chairman. That increases his family office's total equity investment in Renovacare since 2013 to more than $20 million. The company is developing the regenerative Skingun technology, an autologous stem cell system designed to spray a liquid suspension of a patient's stem cells onto wounds such as burns, chronic and acute wounds and scars. Read More
