FDA approvals spur deals and pipeline expansions for pharma firms
The U.S. Food and Drug Administration granted several new clearances this week, including Johnson & Johnson's Dual Energy THERMOCOOL SMARTTOUCH SF catheter system and Vera Therapeutics' accelerated approval of TRUTAKNA for IgA nephropathy. AbbVie and Genmab received EU approval for the bispecific lymphoma therapy TEPKINLY, while Accord BioPharma's Ennumo (pegfilgrastim‑pccg) was cleared as a biosimilar to Neulasta.
In parallel, major commercial and strategic moves were announced. Vertex Pharmaceuticals agreed to acquire Crinetics for roughly $10 billion, adding the acromegaly drug PALSONIFY to its portfolio. Virax Biolabs secured a multi‑country supply deal with Fosun Diagnostics for Southeast Asian markets, and Vivani Medical partnered with Novo Nordisk to evaluate a long‑acting semaglutide implant. Chemomab Therapeutics merged with AI‑focused Scipher Medicine to advance an anti‑CCL24 antibody, and Teva signed a global licensing agreement with Polpharma Biologics for a proposed Ocrevus biosimilar. Industry analysts noted that the growing share of temperature‑sensitive specialty therapies is reshaping supply‑chain strategies.