Exelixis Inc. will waste no time making Cabometyx (cabozantinib) available to advanced renal cell carcinoma (RCC) patients who have received prior anti-angiogenic therapy, following the FDA's widely anticipated approval Monday. Read More
Even before the FDA approved Sandoz Inc.'s Zarxio nearly two months before its target date, conventional wisdom was that U.S. versions of biosimilars approved and launched in the EU would have a smoother sail through the FDA review process. Read More
SHANGHAI – Hua Medicine Ltd. has raised $50 million in a series C investment led by China-based Harvest Investments. Hua is now preparing a phase III trial for its lead candidate, HMS5552, a fourth generation glucokinase activator (GKA) for type 2 diabetes. Read More
TOKYO – In a world's first, Japan-based Sanbio Inc. will conduct a phase II global trial into a treatment for chronic traumatic brain injury with allogeneic stem cells. Read More
HONG KONG – Efforts are under way in Latin America to speed up the development of a vaccine for the Zika virus that has ran rampant in parts of the continent, most notably Brazil. Read More
Aytu Bioscience Inc. CEO Josh Disbrow told BioWorld Today that confusion over what endpoints might be acceptable to the FDA in trials with therapies for low testosterone "is a bit of an anomaly, and frankly we view it to some degree as a barrier to entry that's relatively unique." In any case, the market for topical treatments "isn't going away," he said. Read More
Aviragen Therapeutics Inc., of Atlanta, signed a definitive agreement to receive a cash payment of $20 million from Healthcare Royalty Partners in exchange for an undisclosed portion of the company's royalty rights related to Inavir (laninamivir octanoate), an inhaled neuraminidase inhibitor that is approved in Japan for the treatment and prevention of influenza. Read More
Evoke Pharma Inc., of Solana Beach, Calif., said it completed patient enrollment in its pivotal phase III study of EVK-001, its nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in women. Read More
