HONG KONG – Following positive phase II data on Hanmi Pharmaceutical Co. Ltd.’s once-weekly GLP-1/glucagon receptor dual agonist, efinopegdutide, in nonalcoholic steatohepatitis (NASH), the Seoul-based company has exclusively licensed the drug to Kenilworth, N.J.-based Merck & Co. Inc. for the indication.
Medtronic plc has won U.S. FDA approval of its Interstim Micro rechargeable sacral nerve stimulator and Interstim Surescan MRI leads for the treatment of urinary and bowel dysfunctions. The new products make Medtronic the only company to offer a choice between rechargeable and recharge-free sacral neuromodulation (SNM) systems, allowing patients to align their treatment with personal lifestyle preferences.
Shares of Cymabay Therapeutics Inc. (NASAQ:CBAY) shot 37% higher on Monday after top-line data showed 78.2% of people with primary biliary cholangitis (PBC) in the company's disrupted phase III test of seladelpar achieved the primary composite outcome after just three months on a 10-mg dose of the drug vs. 12.5% in the trial’s placebo arm.
LONDON – Enthera Pharmaceuticals Srl has announced the largest international series A to date for an Italian biotech, closing a €28 million (US$32.9 million) round, to take programs in type 1 diabetes and inflammatory bowel disease (IBD) into phase I development.
The FDA has lifted all the clinical holds it placed on seladelpar from Cymabay Therapeutics Inc. for INDs in nonalcoholic steatohepatitis (NASH), primary biliary cholangitis (PBC) and primary sclerosing cholangitis, giving the company new hope.
Exero Medical Ltd. aims to improve monitoring the gastrointestinal system after surgery with a wireless, biodegradable anastomotic leak sensor implant. It has started a tiny five-patient, first-in-human study as a proof of concept for its technology.
IPOs from Alx Oncology Holdings Inc. and Pandion Therapeutics Inc. launched July 17 as investors continued to pour money into biopharma’s public sector. Through June, $8.53 billion in biopharma IPOs had been filed so far this year by 35 companies.
Strongly positive histological data from Akero Therapeutics Inc. is being seen as setting a potentially new high bar in treating nonalcoholic steatohepatitis (NASH), but 89bio Inc.’s NASH treatment, on a similar development timeline, is sharing in the success.
Toss a complete response letter (CRL) onto two missed PDUFA dates and a few adcoms that were discussed but never actualized to get an idea of where Intercept Pharmaceuticals Inc. now stands with its NDA for obeticholic acid (OCA) to treat fibrosis due to nonalcoholic steatohepatitis (NASH).
By targeting chimeric antigen receptors (CARs) to a senescence marker, researchers at Memorial Sloan-Kettering Cancer Center have developed a CAR T cell that had beneficial effects in mouse models of both liver fibrosis and lung cancer.