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After more than a month of speculation over how the FDA will rule on Novavax’s application for an updated formulation of its COVID-19 shot, CEO John Jacobs said on the company’s Q1 earnings call: “When we have it, we’ll have it. Until then, we don’t have it.”
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A handful of billion-dollar deals in the rare disease space highlights the uptick in Big Pharma’s investment, but it’s still extremely low compared to the money flowing to more common indications.
Investigational CAR T therapies stole the spotlight at the American College of Rheumatology Convergence as data presented by Bristol Myers Squibb, Kyverna Therapeutics and more highlighted their potential to effectively treat lupus.
In this deep dive BioSpace explores the opportunities and challenges presented by the FDA’s accelerated approval program.
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CSL Behring announced survey results showing that the majority of surveyed people living with chronic inflammatory demyelinating polyneuropathy agree they are interested in exploring more convenient treatment options and that administering treatment at home is extremely/very important to them.
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Read our takes on the biggest stories happening in the industry.
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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Led by alums from Takeda and Boston Pharmaceuticals, Hillstar Bio is working on treatments that remove harmful immune cells to relieve disease.
Merck joins a growing list of companies targeting lipoprotein(a), high levels of which are associated with an elevated risk of adverse cardiovascular outcomes.
President Donald Trump’s tariffs on pharmaceuticals “to come at some point,” per CNBC, as companies promise to build infrastructure in the U.S.
The Eylea franchise was in need of a win after an appellate court last week denied the pharma’s bid to block Amgen’s biosimilar from the U.S.
If confirmed, Susan Monarez will have her work cut out for her, facing a measles outbreak that has already killed two people—the first measles-related deaths in the U.S. since 2015.
The company, launched with help from ex-Novartis executives, is targeting glutamate signaling in the brain to help treat alcohol- and cocaine-use disorders, among other indications.
Novo will license UTB251, a triple hormone receptor agonist that in mid-2023 achieved 24% weight reduction at 48 weeks in a mid-stage study.
The investments come amid an ongoing insurance fraud probe into AstraZeneca’s former China head Leon Wang—and despite mounting pressure from President Trump for pharma companies to re-shore their manufacturing operations.
AbbVie claims that Genmab turned a blind eye to trade secret theft allegedly used to support the development of ProfoundBio’s investigational antibody-drug conjugates. Genmab acquired ProfoundBio in May 2024.