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  • 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 · 1mo agoRegulatoryNegative↗ 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 · 1mo agoRegulatoryNegative↗ source
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  • Analyst warns AstraZeneca-BMS merger could spark regulatory hurdles and job cuts
    Angus Liu writes an editorial warning that talks of a merger between AstraZeneca and Bristol Myers Squibb could create more problems than benefits. He notes that the two companies have only discuss…
    Fierce Biotech · 1mo agoDealNegative↗ 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo agoNeutral↗ source
  • BlossomHill Therapeutics targets $112 million IPO to fund EGFR lung-cancer drug BH-30643
    BlossomHill Therapeutics, a San Diego oncology biotech, announced plans for an initial public offering to raise about $112 million. The company intends to sell 7.8 million shares at $15-$17 each,…
    Fierce Biotech · 1mo agoDealPositive↗ 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 · 1mo 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 · 1mo 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 · 1mo agoNegative↗ 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 · 1mo 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 · 1mo 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 · 1mo agoRegulatoryNeutral↗ source
  • Medical schools debate AI scribes as teaching tools versus learning crutches
    Hospitals have rapidly adopted AI-powered note-taking tools, saying they reduce physician burnout and boost revenue. Medical schools, however, are cautious. While they want graduates to be comfort…
    STAT · 1mo agoNeutral↗ source
  • FDA releases new guidances on adhesives and skin irritation testing for transdermal drug products
    The U.S. Food and Drug Administration has issued two new guidances that focus on transdermal and topical delivery systems used for generic medicines. One guidance, finalized, provides recommendati…
    raps · 1mo agoRegulatoryNeutral↗ source
  • New York Senate advances assisted-dying bill as Nebraska Medicaid work rules spark coverage losses
    The New York Senate moved forward with legislation that would allow assisted dying, marking a significant step toward legalizing the practice in the state. In Nebraska, the recent implementation o…
    STAT · 1mo agoNeutral↗ source
  • Boticelli Foods recalls Bettergoods pistachio nut butter over possible Salmonella contamination
    Boticelli Foods of Melville, New York announced a recall of one lot of Bettergoods Pistachio Nut Butter, a 6.7‑oz (190 g) product identified by UPC 194346207961 and lot number LB028ACP04. The reca…
    fda recalls · 1mo agoRegulatoryNegative↗ 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 · 1mo agoNeutral↗ source
  • Nominations Open for 2026 Fiercest Women in Life Sciences, Deadline Sept 18
    Nominations are now open for the 2026 Fiercest Women in Life Sciences, an annual report that spotlights women making significant contributions across pharma, biotech, medtech, academia, venture cap…
    Fierce Biotech · 1mo agoPositive↗ source
  • Neurologist Who Diagnoses ALS Patients Receives Own Diagnosis, Reflects on Impact of Disability
    Dr. Christopher Campos, a neurologist and assistant professor at UC Davis Health, disclosed that he was diagnosed with amyotrophic lateral sclerosis (ALS) in 2025 after a decade of delivering the s…
    STAT · 1mo agoNegative↗ source
  • Michigan Supreme Court permits state probe into Eli Lilly insulin pricing
    A divided Michigan Supreme Court on Friday ruled that the state attorney general can move forward with an investigation into Eli Lilly’s insulin pricing. The 4-to-3 decision overturned a lower-cou…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Senate stopgap bill temporarily blocks White House plan to politicize federal research grants
    Senate leadership released text of a bipartisan continuing resolution that would fund the government through Dec. 11 and include a provision blocking the White House's proposal to place political a…
    STAT · 1mo agoRegulatoryNeutral↗ source