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.
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.
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%.
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.
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.
The SEC filed civil charges against CBA Pharma Inc. and two top executives in U.S. district court, alleging they conducted a fraudulent securities offering that raised about $4.1 million from nearly 160 investors.
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Biogen, Eisai, Hemex, Krystal, Median Technologies, Peijia, Sanofi.
Clinical updates for biopharma and med tech, including data readouts and publications: Anixa, Atraverse, Biofrontera, Breye, Cala, Clearmind, Estrella, Johnson & Johnson, Lumosa, Rapid, Roche, Zenas.