Four months after Vertex Pharmaceuticals Inc.’s U.S. FDA nod for Journavx (suzetrigine) as the first drug targeting NaV1.8 for treating pain, Eli Lilly and Co. is joining the potential competition via a buyout of Siteone Therapeutics Inc., a privately held firm developing small-molecule sodium channel inhibitors, including a phase II-ready NaV1.8 inhibitor.
GSK plc knew a good thing when it swooped in nearly three years ago to rescue Spero Therapeutics Inc.’s oral antibiotic from a complete response letter (CRL). New pivotal phase III study data showed tebipenem pivoxil hydrobromide (HBr) for complicated urinary tract infections (cUTI), including pyelonephritis, hit its primary endpoint.
Backers of Jena, Germany-based Inflarx NV have turned their attention to the rest of the pipeline after the stock-jolting news from an independent data monitoring committee (DMC) responsible for the unblinded interim analysis of the phase III trial with vilobelimab in pyoderma gangrenosum (PG). The panel recommended stopping the trial due to futility, although no adverse events were noted in the analysis, which was carried out on the first 30 patients who signed up for the experiment.
GC Genome Corp. priced a Kosdaq offering of 4 million shares at ₩10,500 per share May 27, entailing a gross ₩42 billion (US$30.5 million) raise in early June. The Yongin, South Korea-based genomics subsidiary of GC Biopharma Corp. fixed its shares price to the top of its ₩9,000 to ₩15,000 price band May 27 after conducting demand forecasting on domestic and international institutional investors from May 19 to May 23.
A new version of a drug candidate that failed in a phase II for neuropathic pain 15 years ago has attracted $140 million in series D funds, plus an ex-North American deal worth up to $570 million, for Grin Therapeutics Inc.
More and more, artificial intelligence is becoming inseparable from drug development. But it needs to be well integrated with the right people and support technologies in order to be successful, according to Josep Bassaganya-Riera, the founder and CEO of Nimmune Biopharma Inc. With more than 20 years in the industry, he shared his insights and experience about the crucial importance of getting technology and people in balance.
Without convening the U.S. CDC’s Advisory Committee on Immunization Practices, Health and Human Services Secretary Robert Kennedy decided to bring the government’s COVID-19 vaccine recommendations in line with the FDA’s new “evidence-based” approach to the shots.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arcutis, CSL, Genentech, GSK, Roche, Soleno, Springworks, Xbrane.
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