C4 Therapeutics Inc.’s degrader-antibody conjugate (DAC) strategy gathered more steam with a new collaboration between the firm and Roche AG that brings $20 million up front with the potential for more than $1 billion in discovery, regulatory and commercial milestone payments. Read More
More than four decades on from the approval of the first biologic drug, the industry has reached a tipping point, and biotech drugs now outnumber small molecules in the global R&D pipeline. Read More
Armed with a fully subscribed $80 million series D round, Life Biosciences Inc. is making progress with its lead candidate, ER-100, which is in phase I trials testing its theory on reversing the biological effects of aging via partial epigenetic reprogramming. Read More
With three rare pediatric disease priority review vouchers (RPD PRVs) awarded just since the end of March, the nearly year-and-a-half lapse in the program’s reauthorization seems to have had little short-term impact. The three new vouchers bring the total RPD PRVs granted so far this year to seven – one more than the agency issued all last year and down two from the nine given in 2024. Read More
Total biopharma financings reached $22.82 billion in the first quarter (Q1) 2026, rising about 74% from $13.12 billion in Q1 2025 but declining 31% from $33.16 billion in Q4 2025. The strong start places 2026 well above the subdued levels seen from 2022 through 2025, though is still below the highs of $38.35 billion in Q1 2021 and $47.25 billion in Q1 2024. Overall, the data indicate a meaningful rebound in financing activity to begin 2026, following a more uneven 2025. Read More
Everest Medicines Ltd. has agreed to acquire a Singapore-based commercial unit of Hasten Biopharmaceuticals (Asia) Ltd. for $150 million up front, gaining market authorization holder rights to 14 marketed products originally developed by Takeda Pharmaceutical Co. Ltd. Read More
Endospan Ltd. Secured U.S. premarket approval for its Nexus aortic arch stent graft, bringing the company closer to being acquired by Artivion Inc. Under the terms of an existing agreement, Artivion has an option to acquire Endospan at any time within 90 days of the FDA approval. Read More
The U.S. FDA issued a warning letter to Medline Inc. having identified several issues with its Namic brand angiographic control syringes and manifolds used for the intra-arterial or intravenous administration of radiographic contrast media. The agency warned the company that failure to promptly address the violations identified in the letter may result in regulatory action being initiated, including seizure, injunction and civil money penalties. Read More
In a decision that maintains the regulatory status quo, the U.S. FDA denied a petition from Harrison.ai to partially exempt certain diagnostic/detection AI devices from premarket review so long as the manufacturer has 510(k) clearance for a device in a similar category and a robust postmarket plan. Read More
New hires and promotions in the biopharma and med-tech industries, including: Aravax, Impedimed, Latigo, Orano Med, Remedy, Spectral AI, Stealth, Stoke, Supira. Read More
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Anumana, Bausch + Lomb, Becton Dickinson, Cortec, Endospan, Etiometry, GSK, Plus, United, Waters. Read More
