HONG KONG – India's Central Drugs Standard Control Organization (CDSCO) has been streamlining regulations to standardize its rules on the market for pharmaceuticals.
The FDA's green light for the submission of Amicus Therapeutics Inc.'s new drug application (NDA) for migalastat in Fabry disease followed what John Crowley, chairman and CEO, called a "data-driven, science-based discussion" with "largely the same reviewers" within the same FDA review division who previously looked askance at the company's data package.
With multiple phase II readouts ahead this year, Arena Pharmaceuticals Inc. is "putting all the pieces on the table and we'll assemble them in a way that brings the astronauts back to earth," CEO Amit Munshi told BioWorld.
Uniqure NV, of Amsterdam, reported data from an ongoing phase I/II trial of its gene therapy, AMT-060, showing that AAV5-mediated gene transfer was possible in three patients with hemophilia B who have pre-existing anti-AAV5 neutralizing antibodies.
HONG KONG – With $13.2 million in new financing, Tokyo-based oncology drug developer Anaeropharma Science Inc. now plans to focus on research and development of drug candidates that target hypoxic microenvironments of tumors by using recombinant Bifidobacterium.
Kala Pharmaceuticals Inc., of Waltham, Mass., has filed its form S1A to offer to sell 6 million shares of its common stock, priced between $14 and $16 per share, in an IPO.
Inmed Pharmaceuticals Inc., of Vancouver, British Columbia, said it entered a research and development collaboration with Atera SAS, of France, a tissue engineering company specializing in the development of advanced human tissue models.
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