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835 stories matching this filter · ← front page

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  • 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…
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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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo ago↗ source
  • Lilly posts another ‘blowout quarter’ as focus turns to Foundayo launch
    A strong performance from Mounjaro overseas boosted Lilly’s results, and the company raised its guidance for the year for both profit and revenue.
    BioPharma Dive · 2mo ago↗ source
  • XTL Bio to acquire psychedelic biotech; WuXi AppTec’s Q1 revenue rise
    Plus, news about PCI Pharma: 🏭 XTL Bio steps into psychedelics: XTL Biopharmaceuticals is acquiring 100% of the outstanding shares of psychedelic-focused biotech Psyga Bio. XTL will gain Psyga’s m…
    Endpoints · 2mo ago↗ source
  • What we heard at a health tech conference in Boston
    I just came back from the Digital Healthcare Innovation Summit in Boston earlier this week, where I got a good look into what investors are thinking about. A few impressions: Investors see a ...
    Endpoints · 2mo ago↗ source
  • CVS' healthcare delivery chief eyes potential in clinical AI
    CVS Health has been testing AI tools that deliver healthcare, though it sees too many barriers to using them more widely for now. CVS' President of Health Care Delivery Sree Chaguturu told Endpoint…
    Endpoints · 2mo ago↗ source
  • Updated: Early sales of Lilly’s obesity pill appear to trail Novo’s
    About 20,000 people are taking Eli Lilly’s obesity pill Foundayo after its first 20 days on the market, according to the company’s CEO David Ricks. This points to a markedly slower launch of the dr…
    Endpoints · 2mo ago↗ source
  • The R&D 15: How pharma's top companies spent, won and lost on drug research
    Talking over pharma pipelines with a major drugmaker's development chief, he noted that if you looked at the biggest 50 drugs by revenue, the final one on the list brought in about $4 billion last ...
    Endpoints · 2mo ago↗ source
  • Novartis unveils North Carolina factory as final new build in $23B US expansion
    Novartis on Thursday revealed its plans to build another factory in the US, with the Swiss drugmaker noting that it has now allocated every dollar of its $23 billion promise to expand ...
    Endpoints · 2mo ago↗ source
  • Avalyn, in pursuit of better lung drugs, banks $300M in an IPO
    The biotech will use the proceeds to develop inhalable versions of therapies already on the market for the “idiopathic” and “progressive” forms of pulmonary fibrosis.
    BioPharma Dive · 2mo ago↗ source