Far from eliminating the need for weight-loss procedures, glucagon-like peptide-1 receptor agonists could drive more people to seek them out. At least that’s what Fractyl Health Inc. and Bariendo Inc. hope, and they have strong evidence to support their case with a recent meta-analysis showing that individuals discontinuing the popular weight loss medications regain all their weight and more within two years.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amylyx, Beam, Maat, Pheast, Sanofi, Spinogenix, Teijin, Tenpoint.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agenus, Alto, Aspera, Bioage, Bionet, Chase, Haya, Intragrand, Jikang, Kiora, PT Bio Farma, Redwire, Senju, Talentec, Titan, Transpire, Zydus.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amicus, Ascentage, Beyondspring, Cardiff Oncology, Corcept, Experimental Drug Development Centre, Genmab, Ichnos Glenmark, Immuneoncia, Immunitybio, Imunon, Innovent, Jazz, Johnson & Johnson, Kura, Kyowa Kirin, Nasus, OSE, PDS, Perspective, Remegen, Roche, Traws, Vigil Neuroscience.
New hires and promotions in the biopharma industry, including: A&As: Ability, Ardelyx, Asgard, Entrada, Harvard, Lobe, Priothera, Protara, Sernova, Tenpoint.
The U.S. FDA gave Sarepta Therapeutics Inc.’s rAAVrh74 viral vector, used in an investigational gene therapy for the treatment of limb-girdle muscular dystrophy, a step up, making it one of the first platforms to receive the agency’s platform technology designation.
South Korea’s pharmaceutical exports rose nearly 18% year-on-year to reach $2.56 billion in the first quarter (Q1) this year, according to the Korea Health Industry Development Institute. Medical device exports, however, dropped about 5% in Q1 2025 to $1.39 billion, attributed to a drop in trade of implant products to both China and the U.S.
Moderna Inc. once again emerged the winner in a court skirmish over claims that its COVID-19 vaccine infringed two Alnylam Pharmaceuticals Inc. patents. The U.S. Court of Appeals for the Federal Circuit issued a precedential opinion May 4, agreeing with a federal district court in Delaware that Moderna didn’t infringe the patents. For both courts, the decision was based on a single issue of claim construction.