Becoming the second drug approved by the U.S. FDA for tenosynovial giant cell tumors, Deciphera Pharmaceuticals Inc.’s oral CSF1R inhibitor vimseltinib, newly branded Romvimza, could take significant market share from a competitor in the same class. A phase III trial showed a higher objective response rate with Romvimza than a separate phase III trial showed with Daiichi Sankyo Co. Ltd.’s Turalio (pexidartinib), and the latter’s label contains a boxed warning on rare but serious and sometimes life-threatening liver side effects. Read More
The first clinical data from an FDA-approved trial of a CAR T-cell therapy in the treatment of multiple sclerosis (MS) show the cells cause complete B-cell depletion, leading on to a reset of the immune system that is accompanied by an improvement in symptoms. Read More
As part of a U.S. government-wide reduction in force aimed at restructuring and streamlining federal agencies, 5,200 Health and Human Services employees reportedly received their pink slips over the weekend, with 1,165, or 22%, of those at the NIH. Read More
The former head of the U.S. NIH has sounded a warning that the uncertainty caused by the Trump Administration’s funding cuts and layoffs is blocking “critical work” and “paralyzing” biomedical research. “Every time we launch a new program, every time we continue to commit resources to ongoing work, those are important decisions that we make every single day, and in times like this, that decision-making is paralyzed,” said Monica Bertagnolli, who stood down as director of the NIH on Jan. 17. Read More
Septerna Inc.’s stock plunged as much as 68% throughout the day Feb. 18 on news that the company was stopping a phase I trial of SEP-786 in healthy volunteers following two severe events of elevated unconjugated bilirubin in the highest dose cohort of the multiple ascending-dose portion of the study. Read More
With Gilead Sciences Inc. stepping away from its exclusive option rights to casdatifan in treating cancer, Arcus Biosciences Inc. has decided to move on by pricing a $150 million common stock offering. Arcus said Gilead’s rights to the HIF-2a inhibitor, which just produced positive early phase data, had expired. Read More
Solid Biosciences Inc. is preparing for a sit-down with the U.S. FDA this year to discuss the firm’s results with the next-generation gene therapy SGT-003 for Duchenne muscular dystrophy (DMD). Read More
With the U.S. FDA’s approval of Vimkunya, Bavarian Nordic A/S is now in the chikungunya virus infection mix along with Valneva SE’s Ixchiq. A single-dose, adjuvanted virus-like particle-based vaccine to protect against the chikungunya virus infection, Vimkunya is the first of its kind available in the U.S. for those age 12 and older. Read More
A second pentavalent vaccine for preventing meningococcal disease has been approved by the U.S. FDA. GSL plc’s Penmenvy will now go up against Pfizer Inc.’s Penbraya, which had a two-year head start in the market. Read More
The Clarivate Medtech Trends to Watch in 2024 report noted the resilience of the medtech sector in the face of changing macroeconomic factors and the preparation required to navigate the market’s many complexities. It is likely that 2025 will be no different. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allogene, Bayer, BMS, Corbus, Moderna, Oryzon, Pfizer. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Hyloris, Otsuka, Theratechnologies. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arcturus, CSL, Evolus, Galderma, Immunitybio, Nexus. Read More
