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  • Pathos AI signs major ADC partnership with Chinese biotech Alphamab and targets up to $300M Series E raise
    Pathos AI, a technology and drug development company, announced a major antibody‑drug conjugate (ADC) collaboration with Chinese biotech Alphamab. The firm also disclosed a partnership with AstraZ…
    Endpoints · 5h agoDealPositive↗ 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 · 14h agoApprovalPositive↗ source
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  • California Supreme Court rejects claim that Gilead must fast-track safer HIV drug
    Thousands of patients sued Gilead Sciences, alleging the company was negligent for delaying a safer HIV medicine and that they suffered kidney injury and bone loss from the older drug. The Califor…
    STAT · 8h agoRegulatoryNeutral↗ 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 · 13h agoDealNegative↗ source
  • Medicare to End Extra Payments for FDA Breakthrough Devices Starting FY2028
    Medicare announced that it will eliminate the special pathways that have let medical devices labeled as breakthrough by the FDA receive supplemental payments without showing a clear clinical advant…
    STAT · 14h agoRegulatoryNegative↗ 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 · 15h agoDealNeutral↗ source
  • Sandoz to Pay $478.5 Million to Settle Generic Drug Price-Fixing Claims
    Sandoz has agreed to pay $478.5 million to resolve allegations that it participated in a widespread conspiracy to inflate and manipulate the prices of generic medicines. Dozens of U.S. states and i…
    STAT · 17h agoRegulatoryNegative↗ 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 · 10h agoDealNeutral↗ source
  • Eli Lilly’s one-patient early access to retatrutide leaves doctors seeking answers
    Eli Lilly granted a single 79-year-old patient special access to retatrutide, an experimental obesity drug that has shown weight‑loss results comparable to bariatric surgery. Since that decision,…
    STAT · 12h agoRegulatoryNegative↗ 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 · 14h 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 · 15h agoDealPositive↗ source
  • Moderna awaits FDA decision on mRNA flu vaccine as biotech fund launches and pricing disputes intensify
    Moderna is awaiting the FDA's decision on its mRNA influenza vaccine, which could become the first seasonal flu shot using messenger RNA technology. Meanwhile, venture firm TCGX announced a new $4…
    STAT · 16h agoNeutral↗ source
  • AstraZeneca shares drop 5.5% as investors react to reported merger talks with Bristol Myers Squibb
    AstraZeneca's share price slipped on Monday after Reuters reported that the company is in merger talks with Bristol Myers Squibb. The potential combination would create a drugmaker valued at rough…
    STAT · 16h agoDealNegative↗ source
  • BioNTech appoints Guido Oelkers as new CEO, succeeding cofounder Ugur Sahin
    BioNTech announced that Guido Oelkers will become its chief executive officer, taking over from cofounder Ugur Sahin. Oelkers comes from Swedish biopharma Sobi, where he led the company, and bring…
    STAT · 18h 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 · 18h 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 · 18h 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 · 19h agoNegative↗ source
  • In-patient cardiac pre-hab program launched to keep heart-transplant candidates fit while awaiting surgery
    Patients waiting in the hospital for a heart transplant often lose strength and can become ineligible for the procedure as their fitness declines. To address this, Dr. Radha Gopalan at Banner‑Univ…
    STAT · 21h 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 · 1d agoRegulatoryNeutral↗ source
  • Michigan reports first two U.S. deaths linked to cyclospora outbreak
    State health officials said two people died in Michigan, marking the first confirmed U.S. deaths from cyclospora, a microscopic parasite. Both victims had pre‑existing health conditions that may h…
    STAT · 12h agoNegative↗ 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 · 15h agoNeutral↗ source
  • TGA seeks industry input on adopting 11 international scientific guidelines in Australia
    The Therapeutic Goods Administration announced it will consider incorporating eleven internationally recognised scientific guidelines into the Australian regulatory framework. The agency has opene…
    raps · 1d agoRegulatoryNeutral↗ source
  • FDA issues new guidances on adhesive performance and skin irritation testing for generic transdermal drugs
    The U.S. Food and Drug Administration has released two new guidances that address transdermal and topical delivery systems for generic drugs. One guidance, issued as final, focuses on how manufact…
    raps · 1d agoRegulatoryNeutral↗ source
  • FSMB leaders say AI not ready for independent medical licensing
    The Federation of State Medical Boards issued an opinion that artificial‑intelligence tools are not yet suitable for independent medical licensure. The board argues that a medical license is more…
    STAT · 21h agoRegulatoryNeutral↗ source
  • BioNTech appoints Sobi's Guido Oelkers as new CEO, to start by Feb 1 2027
    BioNTech announced that Guido Oelkers, currently a leader at Swedish biotech company Sobi, will become its next chief executive officer. Oelkers is expected to take over the role no later than Feb…
    Endpoints · 18h agoNeutral↗ source