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2,518 stories matching this filter · ← front page

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  • Gilead wins legal battle over HIV drug as Eli Lilly opens early access program for obesity therapy retatrutide
    Gilead Sciences secured a court victory concerning one of its HIV medicines, according to the brief report. The ruling resolves a legal dispute that had been pending, allowing the company to contin…
    STAT · 3mo agoRegulatoryPositive↗ source
  • J&J pharma chief Jennifer Taubert to retire; Krystal Biotech shares plunge after gene therapy revenue shortfall
    Johnson & Johnson announced that Jennifer Taubert will step down as head of its pharmaceutical division after a 21‑year tenure. During her time she oversaw commercial strategy, dealmaking and the…
    BioPharma Dive · 3mo agoNegative↗ source
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  • UK regulator debates whether AI scribes count as medical devices
    UK regulators are examining whether AI-driven clinical documentation tools, often called AI scribes, should be classified as medical devices under current law. The proposal has generated debate am…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Analysis questions expanded orphan drug exemptions under recent legislation
    Ed Silverman, a Pharmalot columnist, examined a provision in the One Big Beautiful Bill Act that keeps certain orphan drugs out of Medicare price negotiations. The Inflation Reduction Act, which b…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Kennedy and Oz dismiss Medicaid cut claims, but state officials warn new rules could strip coverage
    Health secretary Robert F. Kennedy Jr. and former Vice President Dan Oz asserted that the administration is not cutting Medicaid, calling the idea a myth during a farm visit in Michigan. State Med…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Pfizer expands cost-cutting program, targeting $1 billion in new savings through 2029
    Pfizer announced it is expanding a cost-cutting initiative first launched in 2023 to further reduce expenses. The new measures are projected to generate about $1 billion in additional savings by 2…
    BioPharma Dive · 3mo agoNeutral↗ source
  • Eli Lilly expands early-access program for experimental obesity drug retatrutide
    Eli Lilly announced it will broaden its early-access initiative for retatrutide, an investigational drug targeting obesity. The company said the program will let additional patients apply for the…
    STAT · 3mo agoRegulatoryPositive↗ source
  • Aurora Therapeutics halts its custom CRISPR program and cuts staff after competitor Beam moves ahead
    Aurora Therapeutics, a startup developing personalized gene-editing drugs, announced it is abandoning its lead CRISPR program. The decision came just seven months after the company launched, and i…
    STAT · 3mo agoLayoffsNegative↗ source
  • Two Michigan Cyclospora Deaths Reported as Eli Lilly Expands Special Retatrutide Access
    Two people in Michigan have died after contracting cyclospora, a parasitic infection that is rarely fatal but can be severe for those with underlying health conditions. State health officials confi…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Patient finds open-source diabetes app improves control despite lack of FDA approval
    Patient has type 1 diabetes for over 30 years and has used FDA-approved pumps and sensors that were upgraded roughly every five years. Over time his glucose control slipped despite the regulated de…
    STAT · 3mo agoPositive↗ source
  • New York study questions effectiveness of involuntary outpatient mental health treatment, urges more funding for voluntary services
    A new evaluation of New York's involuntary outpatient treatment program adds to a growing body of research on court‑ordered mental health care. The study examined outcomes for people with serious c…
    STAT · 3mo agoNegative↗ source
  • Physician reflects on Quebec's assisted-suicide landscape through Josée Lamère’s story
    Sai Rajagopal, a Canadian physician and researcher, writes an opinion piece that follows the life of Josée Lamère, who became one of the 7.9 percent of Quebecers who have chosen assisted suicide. H…
    STAT · 3mo agoNeutral↗ source
  • 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo agoRegulatoryNegative↗ 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 · 3mo 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 · 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
  • 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 · 3mo 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 · 3mo 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 · 3mo agoNeutral↗ 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 · 3mo agoPositive↗ 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 · 3mo agoNegative↗ 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 · 3mo agoRegulatoryNeutral↗ source