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  • Bristol Myers’ pivotal year; Should AI be swinging bigger?; and more
    Welcome back to Endpoints Weekly! The last week of April brought a downpour of news as several pharma companies reported their first-quarter earnings. Max Gelman took a close look at a make-or-brea…
    Endpoints · 2mo ago↗ source
  • 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 · 2mo 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 ...
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Hematology6
Pulmonology5
Infectious Disease4
Ophthalmology3
Dermatology2
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 Therapeu…
    Endpoints · 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 bio…
    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 $1.1B deal
    🟢 FDA approves Axsome Therapeutics' Auvelity for Alzheimer’s agitation: Axsome said up to 76% of patients with Alzheimer’s disease have agitation, which is characterized by pacing, restlessness an…
    Endpoints · 2mo ago↗ source
  • Summit slips on ivonescimab's apparent interim miss in sign of investor frustration
    Summit Therapeutics’ stock price {$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 Therapeut…
    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 dru…
    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
  • 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…
    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 Lill…
    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 cour…
    Endpoints · 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…
    Endpoints · 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…
    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 Endpoi…
    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…
    Endpoints · 2mo ago↗ source