HONG KONG –Celltrion Group is partnering with Intract Pharma Ltd. to jointly develop an oral tablet form of infliximab. “Celltrion will supply the drug material through clinical evaluation and into the market, while Intract will be responsible for performing clinical studies,” Bill Lindsay, the CEO of Intract, told BioWorld.
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.
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.
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).
Evoke Pharma Inc., of Solana Beach, Calif., which has struggled in the past year through troughs in its stock price and doubts from the FDA in its quest for approval for Gimoti (metoclopramide), was vindicated today as the FDA approved the treatment for adults with acute and recurrent diabetic gastroparesis.
Surrozen Inc., a startup developing regenerative medicines leveraging tissue-specific Wnt modulation, has raised $50 million in series C financing. Proceeds from the round will be used to advance the company’s top two antibodies to the clinic, one for the treatment of severe liver disease and a second for moderate to severe inflammatory bowel disease (IBD).
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