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  • FDA invites stakeholder input to shape a new Quantitative Medicine Innovation Network
    The FDA announced it is looking for feedback from a broad range of stakeholders to help design a Quantitative Medicine Innovation Network (QMIN). The proposed QMIN would be a cross-sector platform…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Amgen drops early-stage obesity drug candidate AMG-513
    Amgen announced it is discontinuing its early-stage obesity candidate AMG-513. The program was in Phase 1, but the company provided no details about the study or the reasons for the halt. A spokes…
    Endpoints · 3mo agoNegative↗ source
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  • Lisata Therapeutics cuts 72% of staff after merger with Kuva falls through and files lawsuit
    Lisata Therapeutics announced it is cutting about 72% of its full‑time workforce after a planned merger with Kuva Labs collapsed. The company had 21 full‑time employees at the end of 2025, so roug…
    BioSpace · 3mo agoLayoffsNegative↗ source
  • Vertex unfazed by competitive IgAN space as FDA verdict looms
    Positive two-year follow-up data for Otsuka Pharmaceuticals’ IgA nephropathy drug Voyxact could support the FDA’s ongoing review of Vertex Pharmaceuticals’ povetacicept, CEO Reshma Kewalramani said…
    BioSpace · 3mo agoEarningsNeutral↗ source
  • Experts debate extra regulation for low-risk digital wellness devices
    Two recent papers published in JAMA have highlighted concerns about low-risk digital health technologies that consumers use. Experts say that even though these tools are considered low-risk, they…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Novo vs. Lilly: Q2's cardiometabolic grudge match
    For years, Novo Nordisk and Eli Lilly have dominated the conversation surrounding obesity medicines as the duopoly competes to lead the largest pharmaceutical category in history. While dozens of c…
    Endpoints · 3mo agoNeutral↗ source
  • 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 · 3mo 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 · 3mo agoDealPositive↗ source
  • 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 · 3mo 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 · 3mo agoNegative readoutNegative↗ source
  • Analysts deem AstraZeneca-BMS merger unlikely despite market buzz
    Analysts say that talks between AstraZeneca and Bristol Myers Squibb are unlikely to result in a merger because the two companies have overlapping product lines that would attract heavy antitrust s…
    BioSpace · 3mo agoDealNeutral↗ 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 · 3mo 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 · 3mo agoNegative readoutNeutral↗ source
  • Analysts Question Potential AstraZeneca-Bristol Myers Megamerger
    Analysts are scrutinizing a recent report that suggests AstraZeneca could merge with Bristol Myers Squibb. The proposed megamerger has sparked a series of questions about strategic fit and executio…
    Endpoints · 3mo agoDealNeutral↗ 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 · 3mo 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 · 3mo agoDealPositive↗ source
  • BioNTech appoints Sobi CEO Guido Oelkers as new chief, founders to launch separate mRNA biotech
    BioNTech announced that Guido Oelkers, current chief executive of Swedish Orphan Biovitrum (Sobi), will assume the role of CEO in early 2027. The move follows the earlier decision of co‑founders U…
    BioSpace · 3mo agoNeutral↗ 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 · 3mo agoDealPositive↗ source
  • Dash Bio secures $30 million Series A funding led by Oak HC/FT
    Dash Bio announced it has closed a $30 million Series A financing round, with Oak HC/FT serving as the lead investor. The capital will be used to expand the company’s platform that offers cloud‑sty…
    Endpoints · 3mo agoDealPositive↗ source
  • Amgen reports hackers stole patient and company data in cloud breach
    Amgen disclosed on Friday that hackers have accessed and taken both company and patient information in a cyber-attack. The company said the intrusion was detected as "unauthorized activity" affect…
    Endpoints · 3mo agoNegative↗ 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 · 3mo agoPositive↗ source
  • FDA releases new guidances on adhesive performance and skin irritation studies for transdermal generic drugs
    The U.S. Food and Drug Administration has issued two new guidances that address transdermal or topical delivery systems for generic drugs. One is a final guidance that outlines how to assess adhesi…
    raps · 3mo agoRegulatoryNeutral↗ 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 · 3mo agoNeutral↗ source
  • Amgen discloses cybersecurity breach affecting patient data
    Amgen reported a cybersecurity incident that resulted in the exfiltration of protected patient health information and other proprietary data stored in cloud services managed by third‑party provider…
    BioSpace · 3mo agoRegulatoryNegative↗ 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 · 3mo agoRegulatoryNeutral↗ source