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3,042 stories matching this filter · ← front page

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  • ICMRA urges cut to animal testing while HHS launches ARPA-H SURPASS program to accelerate clinical trials
    International Coalition of Medicines Regulatory Authorities released a joint statement urging drug makers and national control labs to cut back on animal testing throughout a medicine’s development…
    raps · 20d agoRegulatoryNeutral↗ source
  • HHS unveils ARPA-H SURPASS program to accelerate clinical trial design
    The U.S. Department of Health and Human Services announced a new initiative under ARPA-H called the Simulation‑augmented, Real‑time Platform Adaptive Seamless Trials (SURPASS) program. SURPASS is…
    raps · 20d agoRegulatoryPositive↗ source
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  • Bayer names Christoph Koenen as new chief medical officer as Eric Cantor becomes PhRMA CEO
    Bayer announced that Christoph Koenen, M.D., has been appointed as its new chief medical officer. Koenen, who joined Bayer in 2022 after roles at Bristol Myers Squibb, Novo, Boehringer and GSK, wil…
    Fierce Biotech · 19d agoNeutral↗ source
  • Reporter visits Shanghai to see China’s fast‑growing biotech sector as Chinese‑designed drugs make up about half of the global pipeline
    A STAT+ correspondent traveled to Shanghai to get a first‑hand view of the rapid expansion of China’s biotech industry. The piece describes the bustling research environment and the growing number…
    STAT · 19d agoNeutral↗ source
  • Blue Shield of California plans to adopt Medicare-inspired chronic-care payment model by 2027
    Blue Shield of California, which serves about 6 million members, is among 17 major health plans that have pledged to adopt payment models based on the Medicare Innovation Center's ACCESS Model. Th…
    STAT · 20d agoNeutral↗ source
  • Upcoming FDA decisions in Q3 2026 could signal agency flexibility
    The piece highlights five FDA actions slated for the third quarter of 2026 that industry participants are tracking. Observers say the outcomes may reveal how flexible the agency will be under its…
    BioPharma Dive · 20d agoRegulatoryNeutral↗ source
  • Greenwich Rx voluntarily recalls compounded glutathione injections over possible elevated endotoxin levels
    Greenwich Rx, a 503A compounding pharmacy based in Tomball, Texas, announced a voluntary nationwide recall of specific lots of its compounded glutathione injection product. The recall is being issu…
    fda recalls · 19d agoCRLNegative↗ source
  • Podcast examines growing US mistrust in science and a new gene-editing lawsuit
    The latest episode of The Readout LOUD, a weekly biotech podcast, focused on the erosion of public confidence in science. Hosts Adam Feuerstein, Elaine Chen, and Allison DeAngelis spoke with STAT’…
    STAT · 19d agoNeutral↗ source
  • CDC plans to drop disability questions from health survey, sparking concerns of undercounting
    The Centers for Disease Control and Prevention is proposing a redesign of the National Health Interview Survey that would eliminate questions about disabilities. The change is part of a broader eff…
    STAT · 19d agoRegulatoryNegative↗ source
  • Saint Francis Apizza recalls frozen pizzas over undeclared soy allergen
    Saint Francis Apizza LLC announced a voluntary recall of several frozen pizza varieties because soy allergen was not listed on the label. The affected products include Pepperoni, Plain Cheese, Sup…
    fda recalls · 20d agoCRLNegative↗ source
  • Gias Foods recalls Bettergoods Lemon Alfredo Fettuccine over possible Listeria contamination
    Gias Foods of New York announced a recall of all lot codes of its Bettergoods Authentic Italian Lemon Alfredo Fettuccine after routine testing indicated possible contamination with Listeria monocyt…
    fda recalls · 20d agoRegulatoryNegative↗ source
  • WinCo Foods recalls salsa bean dip trays after recalled peperoncini found in ingredient
    WinCo Foods of Boise, Idaho announced a recall of its ready‑made salsa bean dip trays after learning that the product contains peperoncini from G.L. Mezzetta that had been recalled. The recall cov…
    fda recalls · 19d agoRegulatoryNegative↗ source
  • Trump administration appeals court decision that blocks limits on international student and postdoc visas
    The Department of Homeland Security has filed an appeal after a federal judge ruled that the agency cannot impose new restrictions on how long international students and postdoctoral researchers ma…
    STAT · 20d agoRegulatoryNeutral↗ source
  • STAT+: MAHA goes corporate
    Health care companies dominate the MAHA Summit, and a look at Trump's watered down effort to lower Medicare drug prices.
    STAT · 19d ago↗ source
  • Lilly's amylin-Zepbound combo shows 23% weight loss in type 2 diabetes patients
    Eli Lilly reported that its amylin‑Zepbound combination, eloraTZP, produced an average 23.3% weight loss in adults with type 2 diabetes who were also obese or overweight. The result was derived fro…
    Fierce Biotech · 21d agoPositive readoutPositive↗ source
  • Eli Lilly's retatrutide shows over a third of patients lose 25%+ weight in phase 3 trial
    Eli Lilly presented detailed results from its phase 3 retatrutide trial at the European Association for the Study of Diabetes meeting in Milan and in a recent Lancet publication. The study enrolle…
    Fierce Biotech · 21d agoPositive readoutPositive↗ source
  • Eli Lilly’s Zepbound plus amylin candidate shows 23% weight loss in phase 2 trial, but many patients stopped treatment
    Eli Lilly tested a combination of its GLP‑1 obesity drug Zepbound with the amylin‑targeting candidate eloralintide in a mid‑stage study of people with obesity and type 2 diabetes. After 48 weeks,…
    STAT · 21d agoPositive readoutNeutral↗ source
  • UnitedHealth lawsuit proceeds as judge rejects motion to dismiss earnings manipulation claims
    A federal judge allowed an investor lawsuit against UnitedHealth Group to continue, rejecting the company's request to throw out the case. The suit alleges UnitedHealth inflated its 2024 earnings…
    STAT · 20d agoRegulatoryNegative↗ source
  • GSK pays $12 million to Wave for liver-focused siRNA program, expanding its RNA drug pipeline
    GSK is paying Wave Life Sciences $12 million upfront to take ownership of a hepatic program that emerged from their long‑running collaboration. The payment follows a 2022 agreement in which GSK pa…
    Fierce Biotech · 21d agoDealPositive↗ source
  • Mid-dose petrelintide shows strongest weight loss in phase-2 trial, paving way for pivotal study
    Roche and Zealand Pharma released new phase-2 data for petrelintide, an amylin analog being developed for obesity treatment. In the Zupreme 1 trial, the 5 mg dose achieved the greatest mean weight…
    Fierce Biotech · 21d agoPositive readoutPositive↗ source
  • Trump administration's final Medicare pricing rule limits savings, covering only four firms
    The Trump administration released a final rule intended to lower Medicare prices for drugs administered in physician offices. The rule is part of the Global Benchmark for Efficient Drug Pricing (GL…
    STAT · 20d agoRegulatoryNegative↗ source
  • HHS launches SURPASS program to accelerate clinical trials using AI and adaptive designs
    HHS announced a new five-year initiative called SURPASS, aimed at speeding up and expanding clinical trials by leveraging artificial intelligence and computational modeling. The program, run throu…
    STAT · 20d agoRegulatoryPositive↗ source
  • Bristol Myers revises Phase 3 fibrosis trial after liver safety events, including a death
    Bristol Myers Squibb announced a change to its late-stage Phase 3 "Aloft" trial of the experimental pulmonary fibrosis drug admilparant. The amendment adds closer monitoring for liver-related adve…
    BioPharma Dive · 20d agoNegative readoutNegative↗ source
  • FDA begins review of Roche’s experimental multiple sclerosis pill fenebrutinib
    The FDA has accepted Roche's application for fenebrutinib, an experimental oral therapy for multiple sclerosis, and has started a priority review. The review will evaluate the drug in both relapsi…
    BioPharma Dive · 20d agoRegulatoryNeutral↗ source
  • U.S. plan to cut Medicaid for legal immigrants, including refugees and trafficking victims, takes effect Oct. 1
    Hundreds of thousands of lawfully present immigrants could lose Medicaid coverage beginning Oct. 1, according to state data. The change is part of the One Big Beautiful Bill Act, a Republican effor…
    STAT · 20d agoRegulatoryNegative↗ source