ABL Bio Inc. announced April 7 that it sealed a potential £2.075 billion (US$2.65 billion) license deal with GSK plc, granting GSK global rights to use ABL’s blood-brain barrier (BBB) penetrating bispecific antibody platform, Grabody-B, to develop multiple programs in the neurodegenerative disease arena. Under the terms signed April 5, ABL agreed to transfer Grabody-B-related technology and know-how to GSK, upon which GSK will assume responsibility for preclinical and clinical development, manufacturing and commercialization. Read More
Rhythm Pharmaceuticals Inc.’s sales with Imcivree (setmelanotide) in weight management could exceed $1 billion by 2028 if hypothalamic obesity (HO) is added to the label of the drug, Oppenheimer analyst Leland Gershell said in a report. Boston-based Rhythm rolled out positive top-line data from the pivotal phase III study called Transcend with the melanocortin-4 receptor agonist in HO. The global trial met its primary endpoint with a statistically significant and highly clinically meaningful reduction in body mass index in adult and pediatric HO patients vs. placebo. Read More
The nationwide preliminary injunction keeping the U.S. NIH from slashing its indirect cost rate to a flat 15% has become permanent. In issuing the permanent injunction and final judgment April 4 in three challenges to the rate change, Judge Angel Kelley, of the U.S. District Court for the District of Massachusetts, said the NIH’s Feb. 7 notice that it would begin imposing the 15% rate Feb. 10 to all existing and future grants violated the Administrative Procedure Act, as the action was arbitrary and capricious, was impermissibly retroactive and failed to follow notice-and-comment procedures. Read More
Lexeo Therapeutics Inc. produced more positive interim data from early stage studies of its gene therapy to treat Friedreich’s ataxia cardiomyopathy. The results have prompted the company to continue their ongoing dialogue with U.S. FDA regulators to finalize a registrational study protocol and launch that study by early 2026 with data the following year. Read More
China approved 48 first-in-class innovative drugs, as well as a significant number of medications for pediatric and rare diseases, thanks to measures aimed at enhancing review efficiency and accelerating patient access to novel therapies, according to a report released by China’s National Medical Products Administration. Read More
After gaining 5.78% in January, the BioWorld Cancer Index reversed course, falling 4.74% year-to-date by the end of March. The index’s movement has closely tracked broader market trends. The Nasdaq Biotechnology Index climbed to 5.15% at the end of January but ended the first quarter down 1.54%. Similarly, the Dow Jones Industrial Average rose 4.7% in the first month of the year before slipping to a 1.28% loss through March. Read More
A late 2024 CMS proposal to include obesity drugs like Novo Nordisk A/S’ Wegovy (semaglutide) and Eli Lilly and Co.’s Zepbound (tirzepatide) under Medicaid and Medicare didn’t make it far under the new U.S. administration. A final rule, set to be published in the Federal Register April 15, will not include the provision that would have added obesity drugs to Part D coverage beginning in 2026. Read More
New hires and promotions in the biopharma industry, including: Alpenglow, Betterlife, Cosmo, Crescent, Cue Biopharma, Dark Blue, Exmoor, Formation Bio, Kalaris, Korro, Neurocrine, Novo Nordisk, Nxera, Oncozenge, Phathom, Tasman, Telix, Telo Genomics, Umecrine Cognition. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Arvinas, Johnson & Johnson, Octapharma, Roche, Sinaptica.. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Anthos, Apollomics, Ginkgo Bioworks, Glycomimetics, Novartis, Plex, Roche, Sarepta, Tyg Oncology. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Astrazeneca, Daiichi. Read More
