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  • 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 · 2mo 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…
    Endpoints · 2mo 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…
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Endpoints · 2mo ago↗ source
  • Summit’s ‘self-inflicted’ stumble; Esperion’s take-private deal
    Summit’s decision to conduct an interim analysis of a closely watched trial backfired. Elsewhere, Axsome got a much-needed label expansion and an FDA committee sided against an AstraZeneca breast c…
    BioPharma Dive · 2mo ago↗ source
  • Moderna sees revenue bump from international COVID vaccine sales
    The company is making up for a decline in U.S. vaccine sales with better results elsewhere, continuing a turnaround that’s vaulted its stock price in 2026.
    BioPharma Dive · 2mo 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 · 2mo 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 · 2mo 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 · 2mo ago↗ source
  • FDA approval for Alzheimer's agitation drug; Esperion goes private in $1.1B deal
    🟢 FDA approves Axsome Therapeutics' Auvelity for Alzheimer’s agitation: Axsome said up to 76% of patients with Alzheimer’s disease have agitation, which is characterized by pacing, restlessness an…
    Endpoints · 2mo ago↗ source
  • Bristol Myers’ legacy lift, Biogen’s blue skies and Regeneron’s murky outlook
    Investors are still waiting to see whether Bristol Myers and Regeneron’s pipelines will deliver, while Biogen was lifted by better-than-expected results for newer drugs like Leqembi and Skyclarys.
    BioPharma Dive · 2mo ago↗ source
  • Summit slips on ivonescimab's apparent interim miss in sign of investor frustration
    Summit Therapeutics’ stock price {$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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo ago↗ source
  • Two biotechs raise a combined $556M in latest spurt of IPOs
    Seaport Therapeutics and Hemab Therapeutics on Thursday became the latest drugmakers to debut on Wall Street, continuing a stretch of large IPOs this year that collectively raised almost $3.2 billion.
    BioPharma Dive · 2mo ago↗ source
  • FDA's oncology advisors vote against 'new paradigm' in AstraZeneca trial
    In its first meeting in about nine months, the FDA’s advisory committee of oncology experts voted 6-3 Thursday that a late-stage trial for AstraZeneca’s oral SERD camizestrant didn't show a “clinic…
    Endpoints · 2mo ago↗ source
  • Krazati fails confirmatory trial in colorectal cancer, putting approval at risk
    Bristol Myers Squibb’s cancer drug Krazati has failed its confirmatory study in second-line colorectal cancer, a company spokesperson confirmed to Endpoints News. Krazati had received accelerated a…
    Endpoints · 3mo ago↗ source
  • House panel calls to ban China data from FDA drug trial applications
    A powerful spending committee in Congress wants the FDA to ban the use of clinical trial data from China in future applications by drugmakers to test new treatments. The language was
    Endpoints · 3mo ago↗ source
  • Court dismisses part of Lilly lawsuit against Empower, some claims can proceed
    A federal judge has dismissed part of Eli Lilly’s lawsuit alleging Empower Pharmacy misled customers about its compounded versions of the obesity drug tirzepatide. But the court said some of Lilly’…
    Endpoints · 3mo ago↗ source
  • Supreme Court questions how far generics makers can go with 'skinny label' drugs
    WASHINGTON — Supreme Court justices gave a few hints about how they intend to rule in a divisive case for the pharmaceutical industry. In its final argument scheduled for this term, the high court…
    Endpoints · 3mo ago↗ source
  • Merck still sees ‘compelling’ outlook for Terns leukemia drug
    Despite updated study data that suggest Terns’ treatment may be less differentiated, company executives claimed Thursday that it still could be an important step forward in care.
    BioPharma Dive · 3mo ago↗ source
  • UniQure, in ‘symbolic’ win, to seek UK approval of Huntington’s gene therapy
    News of the submission, which would be the first for UniQure’s closely watched treatment, comes as the therapy faces an uncertain future in the U.S.
    BioPharma Dive · 3mo ago↗ source
  • Avalyn's upsized IPO; Alector ends another study in GSK partnership
    🔔 Avalyn Pharma’s $300M IPO: The Boston, MA-based biotech is selling over 16.5 million shares at $18 apiece. The company is set to start trading as {$AVLN} on the Nasdaq Thursday ...
    Endpoints · 3mo ago↗ source
  • Analysts focus on three programs in big year for Bristol Myers
    Wall Street’s expectations for Bristol Myers Squibb’s upcoming slate of data readouts are reaching a fever pitch. Analysts lobbed questions regarding at least half a dozen trial results expected by…
    Endpoints · 3mo ago↗ source