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1,324 stories matching this filter · ← front page

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  • FDA expands Pluvicto label, allowing most metastatic prostate cancer patients to receive the therapy
    The U.S. Food and Drug Administration has approved an expanded label for Novartis’ radiopharmaceutical Pluvicto, permitting its use together with hormone therapy in metastatic prostate cancer. The…
    Endpoints · 2h agoApprovalPositive↗ source
  • Supernus and Indivior merge to form CNS-focused company with 11 marketed drugs and $2.2B revenue target
    Supernus Pharmaceuticals and Indivior Pharmaceuticals announced an all‑stock merger of equals, creating a central nervous system‑focused company that will combine their product lines and operations…
    BioSpace · 3h agoDealPositive↗ source
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  • Wall Street reacts negatively to AstraZeneca-Bristol Myers merger talks, shares tumble
    A report in the Financial Times, followed by Reuters, said AstraZeneca and Bristol Myers Squibb have been discussing a possible combination in recent months. The news triggered a sharp sell-off. A…
    BioPharma Dive · 1h agoDealNegative↗ source
  • Novo Nordisk’s Phase 3 failure of IL-6 drug ziltivekimab rattles inflammation-focused pipeline
    Novo Nordisk reported that its late-stage IL-6 inhibitor ziltivekimab did not achieve its primary goal in the Phase 3 ZEUS trial, which was designed to lower cardiovascular complications. The disa…
    BioSpace · 6h agoNegative readoutNegative↗ source
  • Curium to acquire Lantheus in $8 billion deal, offering $102.5 per share with upside potential
    Curium announced it will purchase radiopharmaceutical company Lantheus in a transaction valued at about $8 billion. The agreement sets the purchase price at $102.5 for each Lantheus share, and inc…
    Endpoints · 3h agoDealNeutral↗ source
  • Phase 3 failure of AstraZeneca/Ionis antisense drug Wainua shakes ATTR-CM market, opens space for other developers
    AstraZeneca and Ionis Pharmaceuticals reported that their antisense therapy Wainua did not achieve a significant cardiovascular benefit in a Phase 3 trial for transthyretin amyloid cardiomyopathy (…
    BioSpace · 14h agoNegative readoutNeutral↗ source
  • BioNTech appoints Sobi head Guido Oelkers as new CEO to steer oncology shift
    BioNTech announced that Guido Oelkers, who has led the rare‑disease focused Swedish company Sobi since 2017, will become its next chief executive officer. Oelkers is slated to take over the role b…
    BioPharma Dive · 2h agoNeutral↗ source
  • Supernus and Individor to merge, creating $2 billion brain-drug company
    Supernus and Individor announced a merger that will combine their portfolios of neurological medicines. The two firms together generated about $2 billion in revenue in 2025 from roughly a dozen CN…
    BioPharma Dive · 4h agoDealPositive↗ source
  • Supernus and Indivior announce all-stock merger to create CNS-focused drugmaker
    Supernus Pharmaceuticals and Indivior Pharmaceuticals have signed an all‑stock merger agreement to combine their businesses. The new company will be dedicated to developing treatments for central…
    Endpoints · 6h agoDealPositive↗ source
  • Biologics surge drives CMOs and CDMOs to boost sterile fill-finish and prefilled syringe capacity
    Biologics, biosimilars and GLP-1 therapies are increasing demand for sterile injectable products, prompting contract manufacturers to expand capacity. CMOs and CDMOs are adding fill-finish, lyophi…
    BioSpace · 11h agoPositive↗ source
  • China's biotech surge highlights work-life tension for industry leaders
    China's biotechnology sector is accelerating, prompting discussions about the demanding work culture among its leaders. Shefali Agarwal, the US‑based chief executive of Sironax, said she works lon…
    Endpoints · 4h agoNeutral↗ source
  • Biotech leaders urge faster IND process as FDA launches TrialBlazer pilot
    The U.S. Department of Health and Human Services has introduced Operation TrialBlazer, a pilot program aimed at simplifying the investigational new drug (IND) application and approval process. The…
    BioSpace · 14h agoRegulatoryNeutral↗ source
  • BioNTech picks Sobi CEO Oelkers to lead as founders plot new mRNA biotech
    BioNTech’s leadership transition was announced earlier this year, with CEO Ugur Sahin and CMO Özlem Türeci leaving to start a new mRNA company. Guido Oelkers of Swedish Orphan Biovitrum AB will tak…
    BioSpace · 5h ago↗ source
  • ‘Unlikely’ AstraZeneca-BMS mega-merger would be largest pharma deal ever
    If AstraZeneca and Bristol Myers Squibb were to successfully become one company, analysts say it could reset the current deal environment, which has picked up greatly in the first half of the year.
    BioSpace · 6h ago↗ source
  • Amgen hit with cybersecurity breach, patient data affected
    The hack is unlikely to affect Amgen’s financial reporting and other operations, nor does the pharma expect its ability to meet patient needs will be compromised.
    BioSpace · 6h ago↗ source
  • BioNTech names Sobi's Guido Oelkers as incoming CEO
    BioNTech has tapped Sobi’s Guido Oelkers as its new CEO, who will start Feb. 1, 2027, at the latest. Sobi also said Monday it is on the lookout for his replacement. ...
    Endpoints · 6h ago↗ source
  • Dash Bio raises $30M Series A led by Oak HC/FT
    When he first pitched investors on his startup in the fall of 2024, Dave Johnson felt like he was selling an unpopular idea. The typical VC response to his proposed pharma lab services company was:…
    Endpoints · 7h ago↗ source
  • Amgen says hackers stole patient data in cloud breach
    Amgen said Friday that hackers have stolen company and patient information in a data breach. The company said it noticed “unauthorized activity” affecting data stored on cloud platforms hosted by t…
    Endpoints · 7h ago↗ source
  • BlossomHill eyes $112M IPO harvest to bankroll potential Tagrisso challenger
    BlossomHill Therapeutics plans to raise $111.7 million to fund the clinical journey of its potential challenger to Tagrisso.
    Fierce Biotech · 8h ago↗ source
  • After 5-month wait, BioNTech announces Sobi CEO will take on top job at mRNA company
    One of the most closely watched vacancies in biopharma has now been filled, with Sobi CEO Guido Oelkers, Ph.D., moving across to take up the top job at mRNA pioneer BioNTech.
    Fierce Biotech · 11h ago↗ source
  • Editor’s Corner: Why an AstraZeneca-Bristol Myers Squibb merger is a bad idea
    Combining the two drugmakers would trigger severe regulatory concerns and significant pipeline disruptions, cost numerous jobs, all while damaging the broader biopharma ecosystem and hurting patien…
    Fierce Biotech · 17h ago↗ source
  • AstraZeneca and Bristol Myers Squibb reportedly in talks on a mega merger
    AstraZeneca is said to be discussing a possible merger with Bristol Myers Squibb, according to a Financial Times report published on Sunday. The combination would rank among the largest consolidat…
    Endpoints · 21h agoDealNeutral↗ source
  • Alnylam’s stock continues to fall as weekly roundup highlights Q2 earnings across biopharma
    The August 1 edition of Endpoints Weekly opens with a look at the latest biopharma earnings season. Alnylam Therapeutics is highlighted for a continued decline in its share price, reflecting ongoi…
    Endpoints · 2d agoEarningsNegative↗ source
  • Novo Nordisk's heart drug ziltivekimab fails Phase 3 trial, raising doubts on inflammation-targeted therapies
    Novo Nordisk announced that its experimental cardiovascular drug ziltivekimab did not meet the primary endpoint in a Phase 3 study. The trial was designed to see if the drug could lower the inciden…
    BioPharma Dive · 3d agoNegative readoutNegative↗ source
  • Novo Nordisk's late-stage anti-inflammatory heart drug fails Phase 3 trial
    Novo Nordisk announced that its experimental anti-inflammatory compound designed to target cardiovascular inflammation did not meet its primary endpoint in a Phase 3 trial. The study was intended…
    Endpoints · 3d agoNegative readoutNegative↗ source