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The restrictions on Novavax’s vaccine could portend changes at the FDA. Commissioner Marty Makary suggested last week that the agency could update its vaccine approval guidelines “in the coming days.”
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M&A didn’t return as hoped for in 2024. The biopharma industry is heading into the J.P. Morgan Healthcare Conference next week in a grim mood.
Madrigal Pharmaceuticals, X4 Pharmaceuticals and Day One Biopharmaceuticals secured their maiden approvals this year in metabolic dysfunction-associated steatohepatitis, WHIM syndrome and pediatric low-grade glioma. Geron Corporation and ImmunityBio also notched wins.
This year saw lofty highs and devastating lows for neuroscience drug developers like Bristol Myers Squibb, Eli Lilly and AbbVie, following the predictable pattern of successes and failures that characterizes this space.
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Eli Lilly and Company (NYSE: LLY) will participate in Cowen’s 44th Annual Health Care Conference on March 6, 2024.
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The HHS secretary recently canceled $500 million worth of BARDA contracts around mRNA vaccine research. But the U.S. government has already spent billions on this work, which has saved millions of lives.
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Leerink analysts noted, however, that Uplizna’s slow onset of therapeutic efficacy compares unfavorably to would-be competitors in generalized myasthenia gravis.
The Fourth Circuit’s ruling follows a Supreme Court verdict that also allowed the Trump administration to move forward with its mass layoffs at federal agencies.
Known as the home of big-name companies including Johnson & Johnson, New Jersey has become a destination for more and more small and midsize life sciences businesses. Choose New Jersey, Grace Therapeutics and Onyx Equities executives discuss the state’s life sciences scene.
As the industry awaits official word from the administration on how the tariffs will hit, analysts go over the possibilities with one certainty: there will be increased costs for medicines.
Analysts suggested that the tariffs will have little effect on reshoring manufacturing and will likely decrease patient drug access and increase costs.
The National Security Commission on Emerging Biotechnology recommends at least a $15 billion investment into biotech over the next five years.
The FDA approved the use of Opdivo with Yervoy in front-line colorectal cancer, while a Manhattan court junked a class action complaint over the blood cancer drug Pomalyst.
Jazz is being accused of anti-competitive practices regarding its narcolepsy drug, as generic competitors emerge on the market.
A consumer-driven weight loss market could put pharma at greater risk if a recession hits; the continued turmoil at FDA and other HHS agencies magnifies the uncertainty facing the industry; Lilly files a lawsuit against a med spa selling its drugs; and more.
Wegovy and Zepbound are just the latest drug dyads to face-off in the competitive pharma market, continuing a legacy of rivalry that includes blockbuster drugs Keytruda, Humira and Eliquis.