Moderna Inc. blamed a switcheroo by the U.S. FDA for the refusal-to-file (RTF) letter on the seasonal influenza vaccine mRNA-1010. Shares of the firm (NASDAQ:MRNA) closed Feb. 11 at $40.51, down $1.49, having traded as low as $36.66 as investors learned of the RTF letter, which Moderna said is “inconsistent with feedback” the company was given by regulators during pre-phase III as well as pre-BLA-submission talks. Read More
Upstream Bio Inc.’s favorable top-line results from the phase II Valiant trial testing verekitug in adults with severe asthma were not enough to charm Wall Street, and shares of the firm (NASDAQ:UPB) closed Feb. 11 at $14.69, down $13.12, or 47%. Read More
Microbiome specialist Microbiotica Ltd. announced positive data from a phase Ib study of MB-310, an orally administered live biotherapeutic product for treating ulcerative colitis, with 12 of 19 treated patients achieving clinical remission, compared to three of 10 patients in the placebo arm. Read More
Boston Scientific Corp. recently reported new four-year data on its Farapulse pulsed field ablation platform, which demonstrated that patients with paroxysmal atrial fibrillation achieved better long-term success than those treated with thermal ablation. The data come as sales of the Farapulse system in the U.S. have begun to slow amid rising competition from other PFA technologies, particularly Medtronic plc’s Affera platform. Read More
Ascletis Pharma Inc. raised HK$843.53 million (US107.93 million) in a placement on the Hong Kong Stock Exchange to advance its lead program, ASC-30, a small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist that can be dosed once monthly subcutaneously and once daily orally for treating obesity. Read More
The U.S. FDA accepted, with priority review, Takeda Pharmaceutical Co. Ltd.’s NDA submission for oveporexton (TAK-681), bringing the oral orexin receptor 2 agonist closer to clearance in narcolepsy type 1.
Continuing to build on the successful launch of Rezdiffra (resmetirom), Madrigal Pharmaceuticals Inc. is adding six preclinical-stage siRNA therapies to its metabolic dysfunction-associated steatohepatitis (MASH) pipeline in a deal with Ribo Life Science Co. Ltd. and its subsidiary, Ribocure Pharmaceuticals AB, that could be worth $4.4 billion if all milestones are achieved. Read More
The malfunction of lymphatic drainage that occurs in lymphedema leads to excessive cholesterol accumulation in the affected skin and lymphatic vessels, causing inflammation and fibrosis. However, surgery and the chemical reduction of accumulated cholesterol with cyclodextrin reduce inflammation and regenerate lymphatic vessels. Cholesterol is a potential therapeutic target for treating lymphedema, according to this study published on Feb. 11, 2026, in Nature by Veronique Angeli and her colleagues. Read More
Citing an increase in safety events and evidence of futility, the U.S. NIH stopped an investigational low-dose rivaroxaban arm of its Comparison of Anticoagulation and Antiplatelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA) trial. Read More
Beginning Feb. 2, 2026, medical technology news and analysis will be integrated into BioWorld, where curated coverage will continue as part of BioWorld’s core reporting. Read More
New hires and promotions in the biopharma and med-tech industries, including: 4basebio, Boost, Imagenebio, Kdventures, Milestone, Okyo, Renovorx, Santa Ana, Spectral AI, Trisalus. Read More
Clinical updates for biopharma and med tech, including data readouts and publications: Accurkardia, Argá, Cardiol, Evommune, Hengrui, Merrylife, Nektar, Orsobio, Phio, Wat Medical. Read More
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Arthrosi, Avia Vascular, Calla Lily, Cortec, Cumulus, Dynavax, Foghorn, Generation Bio, Merck, Sanofi, Seastar, Shionogi, Sobi, Vygon, Xoma, Yatiri. Read More
