The FDA is issuing an immediately-in-effect (IIE) notice addressing compliance for post-market safety reporting for combination products simultaneously with a draft guidance on the same subject. Read More
Orsenix LLC, of Atlanta, said it completed an end-of-phase II meeting with the FDA and reached a general agreement on the key elements of the phase III program to support an NDA filing for ORH-2014, an oral form of arsenic trioxide, for acute promyelocytic leukemia (APL). Read More
Kalytera Therapeutics Inc., of San Francisco, began development of a cannabinoid-based compound for the treatment of acute and chronic pain. Patents have been filed in the U.S. and other jurisdictions. Read More
Arcus Biosciences Inc., of Hayward, Calif., said it closed its IPO of 8 million shares of common stock at $15 each, with the underwriters also exercising in full their overallotment option to purchase 1.2 million additional shares. The total gross proceeds are expected to be $138 million. Read More
LONDON – Oxford Nanopore Technologies Ltd. has raised £100 million (US$140.2 million) in a placing with new and existing investors, providing the means to build another manufacturing facility to meet rising demand for its range of DNA/RNA sequencers. Read More
HONG KONG – A guild of gut bacteria that helped to alleviate the symptoms of type 2 diabetes mellitus (T2DM) in patients receiving a high-fiber diet, has been identified in a randomized clinical trial performed in China. Read More
LONDON – The dementia charity Alzheimer's Research UK (ARUK) is forming a task force to ensure that if and when any drugs are approved, patients get fast access. Read More
TOKYO – Japan's new accelerated regulatory framework for regenerative medicines has made the time right for U.S. cell therapy specialist Athersys Inc. and its Tokyo-based partner, Healios K.K., "to run a little bit faster," Athersys CEO Gil Van Bokkelen told BioWorld during the 15th BIO Asia International Conference. Jumpstarting the race, Healios is making a $21.1 million equity investment in Athersys and is expected to soon license Multistem, Athersys' allogeneic stem cell product, for multiple indications in Japan. Read More
Shares of Zealand Pharma A/S (NASDAQ:ZEAL) popped 10 percent, closing Tuesday at $16.13 for a gain of $1.52, after the first multinational phase III trial of the company's lead candidate, dasiglucagon, met with success in treating severe hypoglycemia. Read More
To say whether U.S. regulators will require heart monitoring after the first dose of Arena Pharmaceuticals Inc.'s etrasimod for ulcerative colitis (UC) would be "prognosticating a bit in terms of what the FDA is going to choose to do," said Chief Medical Officer (CMO) Preston Klassen, who refused such guesswork. Read More
