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  • A sign spelling Vertex hangs over an office building entrance.
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    Courtesy of Vertex Pharmaceuticals
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    Pain drugs

    Vertex plan to build on pain drug breakthrough hits hurdles

    The drugmaker shed billions of dollars in value after it told investors that widening Journavx’s approval to chronic pain would take more testing. A successor medicine, meanwhile, fell short in Phase 2.

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    Sean Gallup via Getty Images
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    Gates Foundation pledges $2.5B to women’s health research

    The investment, which the foundation says is its largest in women’s health, will support research in maternal health, obstetric care and sexually transmitted infections, among other areas.

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    Алексей Белозерский via Getty Images
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    A brain biotech slumps even with ‘best case’ seizure data

    Positive results from a mid-stage study apparently weren’t enough to raise investor confidence in Praxis Precision Medicines and its experimental drug for epilepsy.

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    Honglouwawa via Getty Images
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    Xoma strikes deals to buy struggling biotechs HilleVax, Lava

    The royalty aggregator’s proposed deals for HilleVax and Lava add to a pattern of “zombie” biotech buyouts this year as the sector’s struggles continue.

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    stock via Getty Images
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    Drugmakers score policy win in fight against 340B

    A new pilot program from HHS will test alterations to the contentious 340B pricing program by swapping traditional upfront drug discounts for rebates.

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    Daniel Tadevosyan via Getty Images
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    News roundup

    Regeneron cancer bispecific rejected again; Allogene discloses trial death

    The FDA issued a complete response letter for Regeneron's lymphoma drug odronextamab. Elsewhere, Bristol Myers raised its guidance and analysts saw progress in Biogen’s turnaround.

  • A gloved hand holds a cluster of psilocybin mushrooms growing from a block of mycelium, illuminated by indoor lab lighting.
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    Alamy
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    Brain drug revival

    In rumored AbbVie deal, Wall Street sees momentum for psychedelics M&A

    A potentially billion-dollar acquisition of Gilgamesh Pharmaceuticals suggests big pharma may finally be willing to place significant bets on psychedelics.

  • The White House in Washington, D.C.
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    TriggerPhoto via Getty Images
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    Trump redoubles threats in attempt to strongarm drugmakers on prices

    The White House set a 60-day deadline for drugmakers to agree on “most favored nation” prices for Medicaid as well as for newly launched drugs.

  • President Donald Trump signs an executive order at the White House on July 31, 2025.
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    Anna Moneymaker via Getty Images
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    US to install country-specific tariffs Aug. 7

    An executive order President Trump signed Thursday codifies rates for over 60 trading partners, including Switzerland. A probe into pharmaceuticals that’s expected to result in sectoral tariffs remains ongoing.

  • An Alnylam logo is displayed on a building in Cambridge, Massachusetts, on Sept. 5, 2024.
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    Jacob Bell/BioPharma Dive
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    Alnylam reaches new highs on strong sales of closely watched rare disease drug

    Despite battling drugs from BridgeBio and Pfizer, Amvuttra beat Wall Street expectations with results Alnylam’s CEO claimed were “not a flash in the pan.”

  • A Moderna logo is displayed on a building in Cambridge, Massachusetts, on Sept. 5, 2024.
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    Jacob Bell/BioPharma Dive
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    Vaccines

    Moderna to lay off 10% of workforce in ‘difficult but necessary step’

    In a memo, CEO Stéphane Bancel said the job cuts are needed to align the struggling vaccine maker’s cost structure with the “realities of our business.”

  • A sign bearing the logo for the Centers for Disease Control and Prevention stands outside of an office building.
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    Elijah Nouvelage via Getty Images
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    Vaccines

    Experts ousted from CDC panel warn of damage to US vaccine policy

    The 17 advisers fired in June by Robert F. Kennedy Jr. urged alternatives to ACIP be organized to limit further degradation in vaccine guidelines.

  • A white sign with the word Lilly written in red stands outside of an office.
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    Scott Olson via Getty Images
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    Lilly’s Mounjaro protects heart health in large diabetic study

    The fast-selling GLP-1 drug matched Lilly's older medicine Trulicity in a closely watched cardiovascular outcomes trial, while showing greater weight loss and blood sugar control.

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    Maximusnd via Getty Images
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    Emerging biotech

    Venture firm Frazier closes $1.3B fund for early-stage biotech investing

    Frazier was among the most active venture investors in 2024, according to analysts at William Blair, backing 17 private life sciences companies.

  • A sign for the FDA is shown in front of the headquarters building in Silver Spring, Maryland.
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    hapabapa via Getty Images
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    Trump administration

    Vinay Prasad’s ouster leaves biotech guessing at FDA direction

    The abrupt exit of the former CBER director raises questions about the FDA’s leadership. For now, newly appointed CDER head George Tidmarsh will take over Prasad’s post.

    Updated July 30, 2025
    FDA
  • A person seated in an armchair looks up at another in this still image taken from a video commercial.
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    Permission granted by Johnson & Johnson
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    J&J tests direct CAR-T marketing with first Carvykti ad

    The new direct-to-consumer ad signals J&J’s confidence in its capacity to meet demand for the cell therapy after earlier manufacturing struggles.

    Updated July 30, 2025
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    Daniel Tadevosyan via Getty Images
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    News roundup

    Madrigal buys into GLP-1 from CSPC; Apellis wins expanded drug approval

    Hong Kong-based CSPC will receive $120 million from Madrigal under the deal. Elsewhere, Apellis and PTC Therapeutics won FDA approvals.

  • A smiling portrait of Vinay Prasad, the director of CBER, set against a sparkling light background.
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    Retrieved from Vinay Prasad on May 08, 2025
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    Vinay Prasad, controversial FDA official, abruptly departs agency

    Prasad's exit ends a tumultuous tenure during which he led a reworking of agency guidelines on COVID vaccines and his office got embroiled in controversy over a Duchenne gene therapy.

    FDA
  • Close-up view of the Novo Nordisk logo mounted on the exterior wall of a building. The logo features a stylized blue Apis bull with a sun disk above its head, symbolizing the company's identity. The background shows a tan brick wall and part of a leafless tree in the foreground under a clear blue sky."
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    Alamy
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    Novo cuts guidance, names new CEO as obesity drug challenges mount

    Knockoff copies of Novo’s weight loss medicine Wegovy have held back sales and put the drugmaker on the back foot in its competition with rival Eli Lilly.

  • A low stone wall partially obscured by long grass bears a Merck & Co. logo
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    Jason Doiy via Getty Images
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    Merck plans spending shift to boost business beyond Keytruda

    Facing an end to Keytruda's market exclusivity, the company will cut $3 billion in costs that it plans to redeploy in support of newer drugs and R&D.