Adding another name to an impressive roster of partners assembled over the past few years, Skyhawk Therapeutics Inc. inked a neurology-focused deal with Merck KGaA aimed at discovering small-molecule RNA-targeted drugs that could be worth more than $2 billion. Read More
With the U.S. FDA clearance of the sNDA for Wegovy (semaglutide) from Novo Nordisk A/S to treat noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), Wall Street speculation deepened as to the consequences for Madrigal Pharmaceuticals Inc.’s Rezdiffra (resmetirom), a thyroid hormone receptor-beta (THR-beta) agonist that won the MASH go-ahead last year.
Beijing Luzhu Biotechnology Co. Ltd.’s shingles vaccine LZ-901 outperformed GSK plc’s Shingrix (HZ/su) vaccine in a head-to-head phase III trial. A recombinant herpes zoster vaccine candidate independently developed by Luzhu, LZ-901 is the company’s core product. Read More
A U.S. appeals court schooled the FDA as it handed Vanda Pharmaceuticals Inc. a “technical knockout” of sorts in yet another regulatory bout with the agency – this one over the FDA’s refusal to grant the company’s request for a hearing after it had received a complete response letter (CRL) for a jet lag supplemental indication for Hetlioz (tasimelteon). Read More
“Our mission is to apply our protein-protein interaction (PPI) big data-generation platform to create novel antibody therapeutics,” Proteina Co. Ltd. CEO Yoon Tae-young recently told BioWorld. “We have been working to build a proprietary technology platform for more than 15 years,” Yoon said, “and we take pride in the fact that we made our own technology platform, instead of running a company based on licensed-in technology.” Read More
With the trial sites now open for its CRISPR-edited T-cell receptor immunotherapy trial, Anocca AB has raised SEK440 million (US$46 million) to fund the phase I part of the multicenter study to completion. The company’s engineered T-cell receptor T-cell therapy (TCR-T) is first being tested against KRAS mutations in pancreatic cancer. Read More
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Invyvid, Neurizon, Omeros, Precigen. Read More
