Dupixent bounces back in treating hives with FDA approval
The U.S. FDA issued a complete response letter in October 2023 for Dupixent (dupilumab) in treating chronic hives but has now approved the monoclonal antibody for the indication. The approval makes Dupixent the first targeted biologic the agency has approved in the past 11 years for chronic spontaneous urticaria. The approval is for use in those age 12 and older who have the condition and who remain symptomatic despite histamine-1 antihistamine treatment. The chronic form lasts more than six weeks. Dupixent is jointly developed by Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., and Sanofi SA, of Paris.
Myasthenia gravis efforts moving forward, AAN attendees hear
Developers continuing their research into new therapies for myasthenia gravis (MG) include such names as Dianthus Therapeutics Inc., which has the phase II Magic study testing DNTH-103 ongoing. An active C1s inhibitor, the compound is matched against placebo in patients with anti-AChR-positive generalized disease. Work in MG by various companies was detailed during the recent American Academy of Neurology meeting in San Diego.
Makary’s vision for slimmed-down US FDA somewhat reassuring
Nearly three weeks into the job, U.S. FDA Commissioner Martin Makary this weekend provided a comprehensive overview of his vision for the much-reduced agency, even as he’s taking first steps to implement it. The comments he made should provide a bit of optimism for the biopharma industry, according to some Street watchers. For instance, Brian Abrahams, head of global healthcare research at RBC Capital Markets LLC, noted that Makary’s “scientifically grounded, level-headed” approach to slimmed down animal testing, appropriate interaction with industry, expedited orphan drug approvals and modernized data capture is “reassuring, in our view, that even this slimmed-down FDA will still function.”
March FDA approvals beat prior months but NME pace stays slow
The U.S. FDA cleared 21 drugs for market in March, topping 16 approvals granted in February and 12 in January. That brought the first quarter (Q1) total to 49 approvals, just one short of the 50 logged in Q1 2024, making it the second-highest Q1 count in BioWorld’s records. As with February, only two of March’s approvals were new molecular entities (NMEs), maintaining a slower pace compared to the 2025 monthly average of just over four NMEs. The U.S. FDA granted approval to Vykat XR (diazoxide choline), marking the first approved therapy for the rare genetic condition Prader-Willi syndrome. The decision came the evening before the drug’s March 27 PDUFA date and sent shares of Soleno Therapeutics Inc. (NASDAQ:SLNO) up 38%. It is the Redwood City, Calif.-based company’s first approved product.
Ouch! Tariffs hit med tech harder than expected
First quarter earnings reports from Johnson & Johnson (J&J) and Abbott Laboratories provided some surprising insights into the likely hit med-tech companies will sustain with current tariffs. The main takeaway? The impact of the trade war with China is far greater than expected by most analysts. J&J expects $400 million in tariff costs for 2025 and declined to predict the impact on an annualized basis, given the high degree of uncertainty about timing and extent of future tariffs. “It would be way too speculative at this point,” said Chief Financial Officer Joseph Wolk. “As we know, these tariffs are very fluid and the responsible action for us now is to quantify what we see the impact in 2026 and then see what happens with respect to – does it lend itself to negotiations with other countries and what's actually in place as we get into the later part of 2025.”
Holiday notice
BioWorld's offices were closed in observance of Good Friday. No issue was published April 18.
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Addex, Adicet, Bavarian Nordic, Bighat, Biosidus, Bright Peak, Channel, Design, Eli Lilly, Evotec, GSK, Janssen, Johnson & Johnson, Ligand, Mindimmune, Neuvogen, Palatin, Pelthos, Pfizer, Regeneron, Scilex, Sernova, Uniqure