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  • Experts warn splitting MMR vaccine into separate shots could increase missed doses and illness
    The article notes that a recent executive order proposes separating the combined measles, mumps and rubella vaccine into three individual injections. The author argues that this change could lead t…
    STAT · 10d agoRegulatoryNegative↗ source
  • Hims & Hers says it can quickly launch six wellness peptides if FDA lifts ban
    Hims & Hers used its second‑quarter earnings call to explain that it is preparing to offer six consumer wellness peptides that are currently prohibited for compounding pharmacies. The company says…
    Endpoints · 10d agoRegulatoryPositive↗ source
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  • Epicrispr raises $90 million Series C after promising early data on epigenetic FSHD therapy
    Epicrispr Biotechnologies announced a $90 million Series C financing round to advance its research program. The company shared early data suggesting that an epigenetic approach could address facio…
    Endpoints · 10d agoDealPositive↗ source
  • Former Legend Biotech chief Ying Huang named CEO of K2, targets $250 million Series A to license Asian assets
    Ying Huang spent the past seven years building one of the leading cancer cell‑therapy companies before stepping down as CEO of Legend Biotech. Weeks after announcing his departure, Huang has taken…
    Endpoints · 10d agoDealPositive↗ source
  • Swiss startup Vaderis raises $152 million to fund Phase 3 trial of rare bleeding disorder therapy
    Vaderis Therapeutics, a 13‑person Swiss biotech, announced a $152 million Series B financing round aimed at advancing its experimental therapy into a Phase 3 study. The company is testing a treatm…
    Endpoints · 10d agoDealPositive↗ source
  • Medicare’s new $50 GLP‑1 weight‑loss drug program may create barriers for patients, warns experts
    Medicare has launched a program that caps out‑of‑pocket costs for GLP‑1 weight‑loss medicines such as Wegovy, Zepbound and Foundayo at $50 a month for eligible beneficiaries. The initiative is inte…
    STAT · 10d agoRegulatoryNegative↗ source
  • Trump’s vaccine executive order likely erodes public trust, says epidemiologist
    President Trump signed an executive order that claims to restore confidence in childhood vaccines by scaling back state mandates and trimming the recommended schedule from 18 diseases to 11. The o…
    STAT · 10d agoRegulatoryNegative↗ source
  • Trump pushes controversial changes to MMR vaccine policy, eclipsing new food additive rule
    President Trump has shifted the national conversation back to vaccine policy, calling for the measles‑mumps‑rubella (MMR) vaccine to be broken up into separate shots. The proposal has sparked immed…
    STAT · 10d agoRegulatoryNegative↗ source
  • FDA rejects ITM Isotope's radiopharmaceutical therapy over manufacturing problems, halting potential competitor to Novartis
    The U.S. Food and Drug Administration has refused to approve a radiopharmaceutical therapy developed by ITM Isotope Technologies Munich SE, citing manufacturing deficiencies. The therapy was desig…
    STAT · 10d agoRegulatoryNegative↗ source
  • Skylark Bio launches first-in-human gene therapy trial targeting deafness
    Skylark Bio, which has operated in stealth, announced that it has dosed the first patient in a gene-therapy trial aimed at treating hearing loss. The study marks the company's entry into the emergi…
    STAT · 10d agoPositive↗ source
  • French study finds stopping statins in low-risk adults over 75 does not raise mortality
    A new French non-inferiority study published in Lancet Healthy Longevity examined whether discontinuing statin therapy in people older than 75 who have no prior cardiovascular disease would affect…
    STAT · 9d agoPositive readoutNeutral↗ source
  • Health insurers' AI spending meets reality check as UnitedHealth pledges $1.5 billion and CVS outlines its own budget
    Two of the largest publicly traded health insurers are emphasizing their artificial‑intelligence initiatives, but industry observers say the hype may outpace actual results. UnitedHealth Group dis…
    Endpoints · 10d agoNeutral↗ source
  • Nurses voice concerns on AI while regulators outline RAPID pathway for breakthrough devices
    The latest STAT Health Tech newsletter, dated August 11, 2026, highlights two contrasting developments in health technology. Nurses interviewed for the piece express skepticism about the impact of…
    STAT · 10d agoRegulatoryNeutral↗ source
  • Nonprofit North Star Review Board offers independent model to fix IRB oversight issues
    Founders Stephen Rosenfeld and Patricia Seymour created the not‑for‑profit North Star Review Board after becoming disillusioned with the current system of institutional review boards (IRBs) that ov…
    STAT · 10d agoRegulatoryNeutral↗ source
  • Nurses push for involvement as AI threatens jobs and patient care
    Nurses, the largest segment of the health‑care workforce, are increasingly vocal about the risks that clinical artificial intelligence poses to their employment and to patient safety. At Montefior…
    STAT · 10d agoNegative↗ source
  • MoonLake Immunotherapeutics’ vague data on its autoimmune candidate draws criticism
    Adam Feuerstein notes that MoonLake Immunotherapeutics announced "positive" results for its autoimmune drug candidate but released data that is difficult to interpret. He reminds readers that biot…
    STAT · 10d agoNegative↗ source
  • FDA rejects ITM radiopharma therapy while WHO defends immunization schedules
    The U.S. Food and Drug Administration has issued a rejection of a radiopharmaceutical therapy identified as ITM, indicating that the product did not meet the agency's requirements for approval. Th…
    raps · 10d agoRegulatoryNeutral↗ source
  • PIC/S releases revised guide on qualification and validation studies for pharma manufacturing
    PIC/S has issued an updated guideline that outlines general principles for qualification and validation studies in pharmaceutical manufacturing facilities. The new guide is intended for both inspe…
    raps · 10d agoRegulatoryNeutral↗ source
  • AbbVie, Novartis and Bristol Myers Squibb sue Illinois over 340B drug discount law
    AbbVie, Novartis and Bristol Myers Squibb each filed separate lawsuits in Illinois this week. The suits challenge a state law that seeks to regulate how manufacturers participate in the 340B drug…
    Endpoints · 9d agoRegulatoryNeutral↗ source
  • Abortion care shifts to remote and private channels as patients seek help outside clinics
    Patients are increasingly turning to non‑clinical avenues for abortion information, a trend that began before the Dobbs decision. A family physician recounts a recent encrypted message from a teena…
    STAT · 10d agoNeutral↗ source
  • AbCellera reports striking Phase 2 results for hot-flash treatment, shares jump 31%
    AbCellera Biologics announced positive Phase 2 data for its neurokinin-3 receptor antagonist aimed at relieving vasomotor symptoms such as hot flashes. The company described the results as strikin…
    Endpoints · 11d agoPositive readoutPositive↗ source
  • FDA advisory panel set to review Grail’s multi-cancer Galleri screening test
    An FDA advisory committee is scheduled to evaluate Grail’s Galleri blood test, which is designed to detect a range of cancers at an early stage. The panel will examine the test’s clinical data, pe…
    STAT · 11d agoRegulatoryNeutral↗ source
  • Jazz Pharmaceuticals to acquire Actio Biosciences for $820 million upfront, targeting ultra-rare epilepsy
    Jazz Pharmaceuticals announced it will purchase Actio Biosciences, a company developing an ultra‑rare epilepsy therapy. The transaction includes an upfront cash payment of $820 million, with the p…
    Endpoints · 11d agoDealPositive↗ source
  • Sionna's CF add-on pill fails to improve outcomes in Phase 2 trial with Trikafta
    Sionna Therapeutics reported that its experimental cystic fibrosis pill, SION-719, did not provide any additional benefit when combined with Vertex Pharmaceuticals' Trikafta in a Phase 2 study. Th…
    STAT · 11d agoNegative readoutNegative↗ source
  • BMS to build $2.3 B Houston plant as MHRA clears Lilly's weight-loss drug; IMDRF issues PCCP guidance
    Bristol Myers Squibb announced a plan to invest about $2.3 billion in a new manufacturing facility in Houston. The site is expected to expand the company’s production capacity for its pipeline and…
    raps · 11d agoRegulatoryNeutral↗ source