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  • Moderna in talks with FDA over Phase 4 Covid vaccine data
    Moderna said it's working with US regulators to provide post-marketing data on its Covid-19 vaccines that could restore their use to a wider group after FDA leaders narrowed the label for the produ…
    Endpoints · 3mo ago↗ source
  • FDA approves Pfizer and Arvinas' breast cancer drug despite underwhelming data
    The FDA on Friday approved Pfizer and Arvinas' drug vepdegestrant for patients with a certain form of breast cancer. But it’s unclear how many will take it. The drug will be ...
    Endpoints · 3mo ago↗ source
  • Amgen launches late-stage obesity trial in patients who switch from rival drugs
    Amgen is launching three new late-stage trials for its long-acting obesity shot MariTide, including one designed to test the drug in patients switching away from Eli Lilly and Novo Nordisk's blockb…
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Infectious Disease253
Nephrology239
Endpoints · 3mo ago
↗ source
  • Q&A: Seaport CEO and CSO on learning from Karuna and the future of CNS research
    Seaport Therapeutics began trading as a public company on Friday after executives rang the Nasdaq’s opening bell. Shares rose {$SPTX} more than 20%. With a team largely made up of Karuna Therapeuti…
    Endpoints · 3mo ago↗ source
  • STAT+: Up and down the ladder: The latest comings and goings
    Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and…
    STAT · 3mo ago↗ source
  • Samsung Biologics workers begin five-day strike over wage disputes
    After holding a rally in April, Samsung Biologics union workers on Friday started a five-day strike over wage negotiations. Around 95% of the company's union members voted on the strike, with the ...
    Endpoints · 3mo ago↗ source
  • Acelyrin founder Shao-Lee Lin emerges at Cue, as it becomes latest to license from China
    Cue Biopharma announced a reboot Thursday afternoon, bringing in notable biotech executive Shao-Lee Lin as well as a new allergy asset developed in Taiwan and mainland China. The Boston-based biote…
    Endpoints · 3mo ago↗ source
  • Save the date: Premium subscriber-exclusive Post-Hoc Live
    Q1 earnings recap with Endpoints News After a deal-heavy first quarter, earnings season is in full swing. We're breaking down the news and trends from Big Pharma's first-quarter calls on a special…
    Endpoints · 3mo ago↗ source
  • FDA approval for Alzheimer's agitation drug; Esperion goes private in $1.1B deal
    🟢 FDA approves Axsome Therapeutics' Auvelity for Alzheimer’s agitation: Axsome said up to 76% of patients with Alzheimer’s disease have agitation, which is characterized by pacing, restlessness an…
    Endpoints · 3mo ago↗ source
  • STAT+: Axsome wins FDA nod for Alzheimer’s agitation
    Vinay Prasad's acting replacement, remembering genomics pioneer J. Craig Venter, and more biotech news from The Readout
    STAT · 3mo ago↗ source
  • STAT+: Pharmalittle: We’re reading about obesity drugs and a compounding list, an AstraZeneca setback, and more
    The FDA proposed excluding the active ingredients in popular obesity and diabetes drugs from a list of substances that can be used for compounded versions
    STAT · 3mo ago↗ source
  • PFAS is still in some infant formula
    Casey Means out as surgeon general nominee, America's renewed fertility anxiety, and more health news
    STAT · 3mo ago↗ source
  • Summit slips on ivonescimab's apparent interim miss in sign of investor frustration
    Summit Therapeutics’ stock price {$SMMT} tumbled nearly 20% after the closing bell Thursday afternoon, following an apparent statistical miss in part of a Phase 3 trial for its cancer drug ivonesci…
    Endpoints · 3mo ago↗ source
  • Amgen files update to Tavneos label as FDA escalates push to withdraw
    Amgen has taken steps to update its Tavneos label amid an ongoing battle with the FDA. The company filed a supplement on Wednesday that would add more information to the warning ...
    Endpoints · 3mo ago↗ source
  • Seaport, Hemab price IPOs, while Avalyn soars in Nasdaq debut
    A trio of biotechs priced their IPOs on Thursday into Friday morning, setting the stage for their public trading debuts with more than $850 million combined. Seaport Therapeutics, Hemab Therapeutic…
    Endpoints · 3mo ago↗ source
  • J&J axes pair of CAR-T therapies for lymphoma, citing evolving market
    Johnson & Johnson is scrapping two CAR-T cell programs for B cell lymphoma amid a wave of approvals in recent years for cell therapies and antibody-based drugs addressing the disease. The drugmaker
    Endpoints · 3mo ago↗ source
  • Boehringer appoints pharma veteran for corporate affairs post; BlueRock CSO heads for the exit
    → Boehringer Ingelheim has brought in Christie Bloomquist as SVP, corporate affairs, US human pharma, and she’ll be president of the Boehringer Cares Foundation. Peer Review informed you about her…
    Endpoints · 3mo ago↗ source
  • Opinion: America is worrying about fertility again. But it’s not really about families
    Where the state once worried about too many births, it now worries about too few.
    STAT · 3mo ago↗ source
  • STAT+: Her daughter Mila got a bespoke medicine. Now she’s starting a new biotech to make more
    Efforts to make customized medicines at scale have hit commercial and regulatory roadblocks. Julia Vintarello is trying again.
    STAT · 3mo ago↗ source
  • ‘Forever chemicals’ in baby formula? Scientists unpack FDA results
    FDA review confirmed overall safety of 16 brands of baby formula. In a STAT Q&A, experts unpack what low-level PFAS findings mean to worried moms.
    STAT · 3mo ago↗ source
  • Opinion: The psychedelic revolution is leaving behind people of color
    Psychedelics’ potential as a form of treatment is virtually unmatched. But their promise faces both scientific uncertainty and thorny political questions.
    STAT · 3mo ago↗ source
  • STAT+: OxyContin maker Purdue Pharma set to dissolve after judge approves its criminal sentence
    At the hearing, the judge heard from mothers who lost sons to overdose, a teenager born into withdrawal, and people who spent years dealing with addiction treatment.
    STAT · 3mo ago↗ source
  • Remembering J. Craig Venter: a relentless scientist who changed biotech — and was all too easily misunderstood
    J. Craig Venter, the scientist whose relentless ambition helped turn genetics from an artisanal trade into an industrialized information machine, died at 79.
    STAT · 3mo ago↗ source
  • STAT+: Katherine Szarama named acting director of FDA’s vaccines and biologics center
    Katherine Szarama, who joined the FDA last year to serve as Vinay Prasad’s deputy, will now fill his shoes at CBER.
    STAT · 3mo ago↗ source
  • STAT+: In her own words: Surgeon general nominee Nicole Saphier expresses enthusiasm and caution for MAHA
    Examining the past statements and writings of Trump's third surgeon general nominee, Dr. Nicole Saphier, on vaccines, autism, peptides, diet and more.
    STAT · 3mo ago↗ source