A year-and-a-half after Eli Lilly and Co.’s Mounjaro (tirzepatide) gained U.S. FDA approval for adults with type 2 diabetes, the GLP-1 and GIP dual agonist was cleared for chronic weight management in adults who are obese or overweight and who also have one related condition. Read More
Carrying through on a policy it adopted a few months ago to crack down on potentially anticompetitive FDA Orange Book listings, the U.S. FTC put 10 drug companies on notice that it’s challenging several of their “improperly or inaccurately listed” patents through the FDA’s regulatory dispute process. Read More
While executives of Durect Corp. plugged “compelling” reduction in mortality from a phase IIb study testing DNMT inhibitor larsucosterol in severe alcohol-associated hepatitis and looked ahead to a potential registrational trial, investors focused on the fact that the study, called Ahfirm, fell short of statistical significance on both primary and secondary endpoints, sending shares (NASDAQ:DRRX) down 79%. Read More
Lumos Pharma Inc.’s novel approach with LUM-201 in pediatric growth hormone deficiency paid off in top-line results, and the company is laying the groundwork for a phase III study next year. Pisit “Duke” Pitukcheewanont, senior vice president of global clinical development and medical affairs for Lumos, told BioWorld that the ability of LUM-201 to generate hormone at the normal range, promoting growth comparable to standard-of-care daily or weekly injections is “groundbreaking.” Read More
Orsobio Inc., already in the clinic with three candidates, has completed its $60 million series A financing. The company, CEO Mani Subramanian told BioWorld, has taken its time to find the right programs, put them together and only raised capital when it saw the programs had legs. Even the series A is a measured step, as Subramanian called the financing “modest.” Read More
South Korea may soon gain its first domestically developed anthrax vaccine by GC Biopharma Corp., with the Korean biotech having filed Nov. 1 with the MFDS for approval of its novel recombinant protein anthrax vaccine called GC-1109. Read More
Biopharmas raising money in public or private financings, including: Celldex, Fibrobiologics, Forward Therapeutics, Karolinska Development, Modus Therapeutics, Nanobiotix. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbisko, Acticor, Akeso, Arcus, Autobahn, Bioray, Cognition, Gate, Gilead, H. Lundbeck, Inventiva, Lapix, Oryzon, Otsuka, Paxmedica, Qualigen, Rampart, Recce, Ventyx. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adaptive, ADC, Alfasigma, Apexigen, Araris, Arbutus, Beigene, Genentech, Intercept, Janssen, Lyell, Mediwound, Polymedics, Pyxis, Taiho, Telix, Wiik, Xencor. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aura, Aviadobio, Clover, Grace, Itolerance, Kadimastem, Salarius, Sobi. Read More
