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.
New hires and promotions in the biopharma and med-tech industries, including: Conexeu, Bioaffinity, Entera, Evogene, Human Longevity, Nervgen, Ocugen, Trained Therapeutix.
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