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1,183 stories matching this filter · ← front page

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  • Vertex drops mRNA cystic fibrosis program over 'tolerability' issues
    Vertex Pharmaceuticals said it has dropped development of an mRNA-based cystic fibrosis therapy after facing challenges similar to those that have troubled other parts of the field in delivering th…
    Endpoints · 2mo ago↗ source
  • FDA search for new CBER head focused on small group of final candidates
    The FDA has narrowed its search for a new leader of its Center for Biologics Evaluation and Research to three or four final candidates, according to a person familiar with the matter. The agency ho…
    Endpoints · 2mo ago↗ source
  • Celcuity strengthens case for ASCO-spotlighted breast cancer drug
    The new data could support a broader approval submission for a therapy that is already under review and set to be showcased at the year’s biggest meeting for cancer research.
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BioPharma Dive · 2mo ago
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  • Supreme Court restores mifepristone access by mail
    The Supreme Court restored mail ordering of mifepristone, reversing a federal appeals court’s stay. The decision Monday came after makers of the pill asked for an immediate response to a ruling ...
    Endpoints · 2mo ago↗ source
  • Celcuity's breast cancer win; Odyssey plans $205M IPO
    Celcuity’s breast cancer drug wins again: The company said two regimens with its experimental drug gedatolisib succeeded in PIK3CA mutant patients as part of its Phase 3 trial. Last year ...
    Endpoints · 2mo ago↗ source
  • With $97M, Latus pursues a different kind of Huntington’s gene therapy
    The therapy is part of a plan to develop gene therapies that can be efficiently delivered at lower doses, enabling them to be used against more than just “ultra-rare” conditions.
    BioPharma Dive · 2mo ago↗ source
  • Biotech has a new startup model: Small team, big check and Chinese assets
    A new flavor of company is shaking up how biotechs are built. Instead of launching with eye-popping early-stage science or a new platform, there's a surge of startups with small teams, large checks…
    Endpoints · 2mo ago↗ source
  • Windward Bio gets $165M to take China-derived drug into Phase 3 asthma trial
    A Swiss biotech with two experimental medicines from China, plus an in-house discovery team, has brought in $165 million to advance into late-stage testing. The startup, Windward Bio, has raised a ...
    Endpoints · 2mo ago↗ source
  • UCB to acquire Candid in $2.2B bet on bispecifics for autoimmune diseases
    The buyout involves a portfolio of antibody drugs Candid licensed from China-based biotechs and that UCB sees as part of the “next wave” of care for immunological conditions.
    BioPharma Dive · 2mo ago↗ source
  • What is your AI drug repurposing strategy missing?
    Fragmented data limits even the most advanced oncology AI. Curated knowledge changes that.
    BioPharma Dive · 2mo ago↗ source
  • UCB bets $2B on Candid's T cell engager ambitions
    Ken Song has done it again. The biopharma veteran's all-out effort to prove T cell engagers' potential in autoimmune diseases is getting picked up by one of Europe’s oldest pharma companies. UCB is…
    Endpoints · 2mo ago↗ source
  • Bristol Myers’ pivotal year; Should AI be swinging bigger?; and more
    Welcome back to Endpoints Weekly! The last week of April brought a downpour of news as several pharma companies reported their first-quarter earnings. Max Gelman took a close look at a make-or-brea…
    Endpoints · 3mo ago↗ source
  • Arvinas’ ‘Protac’ breast cancer drug cleared by FDA
    Known as Veppanu, the drug is the first of its kind to get to market. But Arvinas and partner Pfizer are still searching for a new partner to sell it.
    BioPharma Dive · 3mo ago↗ source
  • Moderna in talks with FDA over Phase 4 Covid vaccine data
    Moderna said it's working with US regulators to provide post-marketing data on its Covid-19 vaccines that could restore their use to a wider group after FDA leaders narrowed the label for the produ…
    Endpoints · 3mo ago↗ source
  • FDA approves Pfizer and Arvinas' breast cancer drug despite underwhelming data
    The FDA on Friday approved Pfizer and Arvinas' drug vepdegestrant for patients with a certain form of breast cancer. But it’s unclear how many will take it. The drug will be ...
    Endpoints · 3mo ago↗ source
  • Amgen launches late-stage obesity trial in patients who switch from rival drugs
    Amgen is launching three new late-stage trials for its long-acting obesity shot MariTide, including one designed to test the drug in patients switching away from Eli Lilly and Novo Nordisk's blockb…
    Endpoints · 3mo ago↗ source
  • Q&A: Seaport CEO and CSO on learning from Karuna and the future of CNS research
    Seaport Therapeutics began trading as a public company on Friday after executives rang the Nasdaq’s opening bell. Shares rose {$SPTX} more than 20%. With a team largely made up of Karuna Therapeuti…
    Endpoints · 3mo ago↗ source
  • 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 · 3mo 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 · 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 $1.1B deal
    🟢 FDA approves Axsome Therapeutics' Auvelity for Alzheimer’s agitation: Axsome said up to 76% of patients with Alzheimer’s disease have agitation, which is characterized by pacing, restlessness an…
    Endpoints · 3mo ago↗ source
  • Bristol Myers’ legacy lift, Biogen’s blue skies and Regeneron’s murky outlook
    Investors are still waiting to see whether Bristol Myers and Regeneron’s pipelines will deliver, while Biogen was lifted by better-than-expected results for newer drugs like Leqembi and Skyclarys.
    BioPharma Dive · 3mo ago↗ source
  • Summit slips on ivonescimab's apparent interim miss in sign of investor frustration
    Summit Therapeutics’ stock price {$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