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The House Committee on Energy and Commerce has cleared proposed legislation that could bring back the FDA’s rare pediatric priority review voucher program, which allows for expedited drug reviews.
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Some of the most high-profile acquisitions in recent years have involved women-fronted biotechs. BioSpace reviews five of the most notable here.
Seven biotech unicorns are advancing AI-powered drug discovery and development—but must contend with a difficult investing environment where competition is steep and the usual roads to exit are uncertain.
More than thirty years since its 1993 founding, Catherine Owen Adams and Elizabeth Thompson—the R&D combo that has led Acadia since last year—are managing two products on the market and a pipeline estimated to be worth an additional $12 billion in sales.
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Arvinas, Inc. and Pfizer Inc. announced updated clinical data from a Phase 1b combination cohort evaluating vepdegestrant, an investigational oral PROteolysis TArgeting Chimera estrogen receptor degrader, in combination with palbociclib.
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Read our takes on the biggest stories happening in the industry.
Following restricted vaccine approvals and changes to CDC immunization schedules, Merck, Pfizer, GSK and Sanofi are all suffering revenue hits to their vaccine programs.
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BioSpace did a deep dive into biopharma female executives who navigated difficult markets to lead their companies to high-value exits.
AMX0035—approved as Relyvrio in 2022 for amyotrophic lateral sclerosis but voluntarily pulled from the market last year—was unable to distinguish itself from placebo in a mid-to-late-stage trial of progressive supranuclear palsy.
Novartis has bet up to $772 million to gain access to BioArctic’s BrainTransporter platform, which was leveraged in a partnership with Eisai to produce Leqembi.
Regeneron’s cemdisiran, used alone or in combination with its complement inhibitor Veopoz, significantly improved activities of daily living in patients with generalized myasthenia gravis.
The layoffs will affect employees at Pfizer’s Bothell, Washington site, which previously served as the headquarters for Seagen before being acquired by the pharma for $43 billion.
Eli Lilly drops a second Phase III readout for orforglipron; AbbVie committed to the psychedelic therapeutics space with the $1.2 billion acquisition of Gilgamesh’s depression asset; the CDC taps vaccine skeptic Retsef Levi to lead its COVID-19 immunization working group; and the FDA prioritizes overall survival in cancer drug development.
As the political winds shift on a whim and public distrust of the pharma industry reaches fever pitch over drug pricing, executives are being asked to navigate an impassible path.
Generate:Biomedicines’ Nicole Clouse is one of the key legal minds trying to understand who owns what AI creates. The answers are critical to the future of biotech.
If the trend holds, IQVIA expects 2025 deal volume between Chinese and multinational companies to easily eclipse the 100 agreements signed in 2024.
While Truist Securities analysts said the results from the ATTAIN-2 trial leave “room for competition,” they also pointed to a manufacturing advantage that could unlock a “double-digit billion dollar opportunity” for Eli Lilly.