Catabasis Pharmaceuticals Inc., of Cambridge, Mass, has filed its S-1A with the SEC to raise $30 million by offering 20.27 million common units consisting of one share of common stock and a warrant to purchase one share of common stock. Read More
Recognizing the dire need for new antimicrobial drugs and the economic hurdles that discourage investment in the field, the FDA is looking for ways to spur antimicrobial innovation. One possibility would be to borrow a reimbursement model from the software world – paying by licensing rather than by dose. Read More
Lumen Bioscience Inc., a Seattle-based company developing biologics on its Spirulina expression platform, said the Bill & Melinda Gates Foundation has tripled its funding commitment for Lumen's low-cost antibody therapeutics program. Read More
If at first you don't succeed, you are not necessarily off the hook, a lesson the FDA has learned all too well in connection with the commercial speech problem. The agency released two new final guidances recently, one for payer communication and the other for general medical product communications, but a significant difference between the drafts and the final guidances is that the final guidances arrive with a nod of approval from two majority members of the House Energy and Commerce Committee, one of the key committees of jurisdiction where FDA issues are concerned. Read More
On the heels of an FDA orphan drug designation for lead compound PU-H71 in myelofibrosis, privately held Samus Therapeutics Inc. moved the small molecule into a phase Ib dose-escalation study in patients with the bone marrow disorder. PU-H71 is designed to target the epichaperome, a protein complex present in more than half of the cancers tested by the company, a spinout of Memorial Sloan Kettering Cancer Center (MSKCC). Read More
The U.S. Court of Appeals for the Federal Circuit said in a recent decision that the U.S. Supreme Court's handling of questions of patent eligibility has made the question unduly difficult, but the Federal Circuit's Judge Alan Lourie is hardly alone. Mark Lauroesch, executive director of the Intellectual Property Owners Association, told BioWorld that there was a time when the U.S. Patent and Trademark Office had issued patents for some undeserving applications, but that the pendulum has gone too far to the other side, and thus "we're now seeing the baby get thrown out with the bathwater." Read More
Birds do it. Bees do it. "Even jellyfish have this need," Qinghua Liu told BioWorld. Liu was referring, of course, to sleep, which he called "essentially... a black box, and one of the biggest mysteries of brain science." Read More
LONDON – New treatments for hematological cancers, including molecularly targeted therapies and immunotherapies, have increased life expectancy but also introduced a host of novel, chronic or cumulative toxicities that are not identified by current approaches to reporting adverse events. Read More
Stridebio Inc., a company developing adeno-associated viral (AAV) vectors for in vivo gene therapies, has raised $15.7 million in an oversubscribed series A financing, money the company said will enable it to move multiple programs toward the clinic, with the first likely to reach proof of concept within the next six to nine months. Read More
Hopes for Flex Pharma Inc.'s phase II FLX-787 swirled down the drain – and so did the share price – after the company said clinical work is stopping because of oral tolerability concerns. Flex (NASDAQ:FLKS) ended Wednesday at $1.04, a loss of $3.14, or 75 percent. Read More
