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Hernexeos is the second drug to secure an FDA approval under the agency’s priority voucher scheme, following in the footsteps of USAntibiotics’ Augmentin XR, which was granted the ticket in December 2025.
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After a rocky 2025, Sarepta Therapeutics’ executives admit they have work to do to bring patients back into the fold as sales of Duchenne muscular dystrophy gene therapy Elevidys continue to decline.
Last week, the FDA made its one pivotal trial policy official, sparking myriad questions from industry leaders, including around specific evidence required for the single study and why it hasn’t been implemented across all therapeutic areas before now.
Alternatives to opioids are desperately needed to better treat moderate to severe acute pain, but to date, we’ve seen few novel analgesics hit the market.
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Eli Lilly’s win in a head-to-head trial drove Novo Nordisk’s market cap to pre-Wegovy levels not long after the victor became the first pharma company to top a $1 trillion valuation. It seems one company can do no right, while the other can do no wrong.
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Biogen’s effort to buy Sage against the board’s wishes and a long-time effort by investor Alcorn to scuttle Aurion’s IPO underscore the cutthroat nature of biopharma dealmaking.
The approval of Axsome Therapeutics’ Symbravo for migraine with or without aura came alongside the greenlight for Vertex’s non-opioid treatment Journavx.
Novartis was among the most prolific pharma dealmakers in 2024, a trend that it expects to continue with more bolt-on deals this year to set up for sustainable long-term growth.
Senators on the Health, Education, Labor and Pensions committee were critical of Kennedy’s long history as an anti-vaccine campaigner.
Blackstone joins other big investors such as ARCH Venture Partners and Bain Capital Life Sciences in pumping billions of dollars into the industry.
The greenlight for Journavx (suzetrigine), which comes on the heels of a $7.4 billion opioid settlement, could spark momentum in the fledgling non-opioid pain space.
Analysts were unfazed by the news that Takeda will cease development of soticlestat after Phase III failures, while responding positively to the announcement that Julie Kim will take the helm of the Japanese giant in 2026.
CAR T–focused biotech Cargo Therapeutics surprised and disappointed analysts when it announced that it would discontinue a mid-stage trial of its lead program, firi-cel.
Sanofi’s jump in earnings comes with an increased emphasis on R&D and vaccines, plus an eye cast toward M&A to shore up its pipeline.
For 2025, Roche will continue a careful approach to high-priced deals, putting science at the center of its business development decisions, executives said Thursday.