Catalyst Biosciences Inc., of South San Francisco, said the Korean Ministry of Food and Drug Safety approved the IND for CB 2679d/ISU304, in hemophilia. CB 2679d/ISU304 is described as a highly potent next-generation coagulation factor IX variant, and it has demonstrated the potential to normalize human factor IX levels with a daily subcutaneous injection in preclinical studies. Read More
Organogenesis Inc., of Canton, Mass., said it acquired Nutech Medical, of Birmingham, Ala., which provides amniotic products for surgical and wound care needs. Nutech’s portfolio includes an amniotic product line for both soft tissue and bone applications. Read More
Nosopharm SAS, of Lyon, France, said it raised €2.4 million (US$2.6 million) in a financing round with Auriga Partners, Kreaxi and Alto Invest joining the company’s longstanding shareholders. Read More
The U.K.’s National Institute for Health and Care Excellence (NICE) said Onivyde (pegylated liposomal irinotecan), a second-line treatment for metastatic pancreatic cancer, doesn’t provide enough benefit to justify its higher cost. Read More
HONG KONG – To facilitate the growth of pharmaceutical markets and expedite drug approvals throughout the 10-country Association of Southeast Asian Nations (ASEAN), a consistent regulatory system is needed. Read More
Lack of a dose response across the three levels of drug tested in part A of the phase II/III turned out to be no big deal for Cara Therapeutics Inc., which scored positive top-line results from its 174-patient experiment showing that intravenous CR845 hit statistical significance on primary and secondary endpoints for efficacy (reduced itching and improved quality of life, respectively) in patients with uremic pruritus (UP). Read More
A peptide extracted from spider venom was shown in an Australian study to reduce brain damage and improve neurological performance in rats, potentially leading to development of new therapies to protect the brain from stroke and other ischemic brain injuries. Read More
LONDON – Bergenbio AS is set to be the fifth European company to list in 2017 after announcing the terms of a $47 million IPO on its local exchange, Oslo Børs. Read More
DUBLIN – Numab Therapeutics AG could earn up to CHF258 million (US$262 million) in up-front and milestone payments from a research and option agreement with Ono Pharmaceutical Co. Ltd., in which it will deploy its multispecific antibody fragment technology in the search for a molecule that simultaneously binds a novel immuno-oncology target nominated by Ono as well as other complementary targets. Read More
Regeneron Pharmaceuticals Inc. won FDA approval for its Sanofi SA-partnered biologic, Dupixent (dupilumab), as a treatment for adults with moderate to severe atopic dermatitis (AD) who are either not helped by topical drugs or for whom those therapies aren’t advised, a group estimated to encompass about 300,000 patients in the U.S. Read More
