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. Read More
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. Read More
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. Read More
After reporting in April that its gastrointestinal reprogramming product (Garp) failed to meet the primary efficacy endpoint in a phase II trial in irritable bowel syndrome (IBS), Anatara Lifesciences Ltd. conducted a further analysis that shows a positive trend toward efficacy. Read More
Epimab Biotherapeutics Inc. licensed out a development-ready KLK2/CD3 bispecific T-cell engager (TCE) for advanced prostate cancer to Juri Biosciences Inc. through a potential $210 million deal. Read More
Glycoengineering specialist Glycoera AG is preparing to take its extracellular protein degrader constructs into the clinic in the treatment of autoimmune diseases, after closing a $130 million series B. Read More
The U.S. Trade Representative (USTR) is asking for help in its search for “freeloaders” that refuse to shoulder their share of the cost of biopharma R&D. Read More
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. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Asklepios, Bayer, Bioxcel, Gilgamesh, Immutep, Innovent, Invivyd, Iolyx, Mineralys, Palisade, Rocket. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Altamira, Ayrmid, Bioinvent, Biolinerx, Boundless Bio, Galmed, Hansa, Novartis, Rheacell, Regulus, Sanofi, Xoma. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbisko, Abelzeta, Astrazeneca, Beigene, Bio-Thera, Hikma, Henlius, Junshi, Liquidia, Moderna, Ocugen, Organon, Otsuka, Poolbeg, Remegen, Samsung Bioepsis, Savara, Traws. Read More
