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  • Kodiak Sciences' Phase 3 eye drug data beats Regeneron’s Eylea, shares double
    Kodiak Sciences reported that its two experimental treatments for macular degeneration met the primary endpoints in a Phase 3 trial that directly compared them with Regeneron’s Eylea. The data show…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Merck, Daiichi end plans to seek speedy approval of lung cancer ADC
    The FDA indicated that the data generated so far wouldn’t support an accelerated clearance of “I-DXd,” a setback that erases an edge Merck and Daiichi had over multiple fast-moving competitors.
    BioPharma Dive · 1mo agoApprovalPositive↗ source
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  • Novo Nordisk rebrands GLP-1 therapy Wegovy as weight-loss product, positioning it as lifestyle drug
    GLP-1 drugs have transformed the lives of millions and were originally promoted as medicines for obesity, a medical condition. Recent advertising campaigns are now presenting these drugs as genera…
    STAT · 1mo agoNeutral↗ source
  • Adicet's off-the-shelf CAR-T shows 50% kidney response in early lupus trial
    An early-stage study of Adicet Bio's off-the-shelf gamma-delta CAR-T cell therapy reported encouraging results in patients with lupus nephritis. After a year of follow-up, half of the evaluable pa…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Rising health insurance premiums and a private equity hospital chain's shift to nonprofit highlight bleak outlook for US healthcare costs
    Bob Herman's latest Health Care Inc. newsletter warns that employer-sponsored health insurance is becoming increasingly unaffordable, with premiums climbing sharply. The piece cites a series called…
    STAT · 1mo agoNegative↗ source
  • AbbVie’s once-daily Parkinson’s pill receives FDA approval
    AbbVie announced that the U.S. Food and Drug Administration has granted approval for its once‑daily oral therapy for Parkinson’s disease. The decision allows the product to be marketed in the Unite…
    STAT · 1mo agoApprovalPositive↗ source
  • GLP-1 drugs shift from obesity treatment to lifestyle products, prompting setbacks for Merck and Daiichi
    The column notes that GLP-1 medicines, originally marketed to treat obesity as a medical condition, are now being promoted more as general lifestyle enhancers for appearance and wellbeing. Novo No…
    STAT · 1mo agoNegative↗ source
  • AI tools that aid vaccine design could also accelerate creation of bioweapons, warns former White House Covid adviser
    Ashish K. Jha, a former White House Covid‑19 response coordinator and senior fellow at Harvard Kennedy School, cautions that artificial intelligence is lowering the barriers that kept biological we…
    STAT · 1mo agoNegative↗ source
  • Trump administration pulls nearly $1 billion from HHS programs for immigrants and diversity
    The White House announced a reversal of almost $1 billion in spending that Congress had previously approved for the Department of Health and Human Services. The reduction was made late on Friday ni…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Operational talent, not just science, will drive next biopharma breakthroughs
    The piece points out that while breakthrough science, founders and venture funding are typical markers of progress, the real test is moving a promising therapy through GMP production, quality syste…
    BioPharma Dive · 1mo agoNeutral↗ source
  • Study finds toxic metal exposure persists months after Maui wildfires
    University of Hawai‘i researchers examined urine samples from about 1,400 adults as part of the Maui Wildfire Exposure Study, one of the nation’s largest investigations of post‑fire health effects.…
    STAT · 1mo agoNegative↗ source
  • Azurity urges simpler medicines for children to reduce daily burdens on families
    Azurity Pharmaceuticals published a sponsored article that looks at how chronic medicines can shape a child's daily routine. The piece points out that while clinical trials test drugs under strict…
    BioPharma Dive · 1mo agoPositive↗ source
  • Trump administration seeks Supreme Court stay on gender-affirming care restrictions in federal prisons
    The Trump administration filed an emergency petition with the Supreme Court asking it to pause a district judge’s order that requires continued provision of gender-affirming medical treatments to i…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Researchers identify previously unseen structure in the human heart
    An author of an opinion piece reports that a close visual inspection of the heart revealed a previously unrecognized anatomical structure. The discovery was made without new imaging technology, sim…
    STAT · 1mo agoPositive↗ source
  • Sierra Nevada Cheese Company recalls all Graziers raw milk cheeses over possible E. coli O26:H11 contamination
    Sierra Nevada Cheese Company of Willows, California, announced a voluntary recall of its Graziers Raw Milk Cheese line, which includes Monterey Jack, Jalapeno Jack, Medium Cheddar and Sharp Cheddar…
    fda recalls · 1mo agoNegative↗ source
  • Former CDC investigator warns that gaps in public-health readiness leave the U.S. vulnerable to future biothreats
    Daniel Jernigan, a former CDC scientist who helped investigate the 2001 anthrax mailings, reflects on the lessons learned two and a half decades later. The anthrax letters, sent from New Jersey to…
    STAT · 1mo agoNeutral↗ source
  • Trump administration cancels nearly $1 billion of congressional spending, targeting refugee and immigrant services
    The White House announced on Friday that it is using a rarely invoked authority to rescind almost $1 billion in funding that Congress had approved earlier. The cuts focus mainly on Health and Huma…
    STAT · 1mo agoNegative↗ source
  • Mezzetta voluntarily recalls 32-oz Golden Greek Peperoncini after pest contaminant found in jar
    G. L. Mezzetta Inc. announced a voluntary recall of its 32‑oz Golden Greek Peperoncini after a video showed a pest contaminant in a jar. The recall is limited to lot 720106 (SKU 10106328). The com…
    fda recalls · 1mo agoRegulatoryNeutral↗ source
  • FDA approves Lilly's once-weekly basal insulin Onswik for adults with type 2 diabetes
    The U.S. Food and Drug Administration has granted approval to Eli Lilly’s Onswik, a basal insulin designed for once-weekly injection in adults with type 2 diabetes. The new formulation offers patie…
    STAT · 1mo agoApprovalPositive↗ source
  • UN-backed agency secures sub-licensing deals for generic Roche flu drug across 129 low- and middle-income countries
    An agency supported by the United Nations has finalized sub-licensing contracts with eleven drug manufacturers to create generic versions of Roche’s influenza medication Xofluza. The agreements al…
    STAT · 1mo agoDealPositive↗ source
  • Novo’s stock tumbles after two-year GLP-1 boom as AI drug-discovery startups land huge funding rounds
    Novo’s shares, which peaked above $140 in June 2024 during a surge in demand for its GLP-1 drugs Ozempic and Wegovy, have fallen sharply over the past two years. The decline reflects a broader mark…
    BioPharma Dive · 1mo agoNegative↗ source
  • RNAi biotech ADARx raises $446 million in IPO, secures $89 million from AbbVie
    ADARx Pharmaceuticals priced its initial public offering at $17 per share, selling more than 26 million shares to raise about $446.3 million. The company also received an additional $89 million th…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Novo signs €1.2 bn deal with Nanexa for long-acting injectables as Acadia’s Alzheimer trial misses target
    Novo has agreed to pay Nanexa up to about €1.165 bn for its PharmaShell delivery platform, which enables long-acting injectable medicines. The partnership will apply the technology to up to five c…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • Five candidates vie for WHO director‑general role as agency faces US funding pullback and tighter global health budgets
    At least five candidates are in the running to become the next director‑general of the World Health Organization, a race analysts say could be the most consequential in the agency's recent history.…
    STAT · 1mo agoNeutral↗ source
  • Veteran Russell Shilling leads new federal autism research initiative
    Russell Shilling, a Navy veteran and father of two sons with autism, has been appointed to lead the Advanced Research Projects Agency for Health's new autism project. The initiative is described a…
    STAT · 1mo agoPositive↗ source