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  • Celea Therapeutics raises $180 million to advance next-generation IPF drug deupirfenidone
    Celea Therapeutics, a PureTech Health spinout, announced a $180 million venture round to fund development of its next-generation idiopathic pulmonary fibrosis (IPF) therapy, deupirfenidone. The ro…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Roche announces drug that sets new benchmark for KRAS‑driven lung cancer
    Roche has announced a new therapy that it says establishes a new standard of care for patients with KRAS‑driven lung cancer. The announcement was featured in a STAT+ newsletter, underscoring the p…
    STAT · 1mo agoPositive readoutPositive↗ source
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  • Biotech Index Surges 30% Year-to-Date as Market Rally Accelerates
    Mid-year data show the biotech sector continuing a strong rally that began in April 2025. The XBI index, the most-watched biotech gauge, rose 19% in June and is up about 30% for the year, trading…
    STAT · 1mo agoPositive↗ source
  • Medicare proposes 33% cut to 340B drug payments for hospitals
    Medicare has released a proposal to cut payments to hospitals for drugs bought through the 340B discount program by more than a third. Under the plan, Medicare would reimburse hospitals at the aver…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Lawmakers ask HHS to compel Eli Lilly to resume 340B hospital discounts
    A bipartisan group of congressional lawmakers has written to HHS Secretary Robert F. Kennedy Jr., urging the department to require Eli Lilly to restore 340B drug discounts for hospitals. Lilly hal…
    STAT · 1mo agoRegulatoryNegative↗ source
  • U.S. Judge Blocks Colorado Panel’s Attempt to Cap Amgen’s Enbrel Price
    A federal judge in the United States issued an order that prevents a Colorado state panel from imposing a price cap on Amgen’s blockbuster arthritis drug Enbrel. The ruling effectively blocks the s…
    STAT · 1mo agoRegulatoryPositive↗ source
  • Federal judge halts Colorado price cap on Amgen's Enbrel drug
    A U.S. district judge issued an injunction that stops the Colorado Prescription Drug Affordability Board from imposing a payment limit on Enbrel, a high-volume biologic sold by Amgen. The court fou…
    STAT · 1mo agoRegulatoryPositive↗ source
  • Former FDA AI regulator says biopharma is misreading agency's guidance, leading to overly cautious approaches
    Tala Fakhouri, who wrote AI policy at the FDA, left the agency last summer and now serves as chief AI and regulatory strategy officer at contract research organization Parexel. She says biopharma…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Genetix, formerly Bluebird Bio, claims rapid turnaround and aims to treat 1,000 sickle-cell patients annually by 2030
    David Meek completed a distressed buyout of Bluebird Bio last year and has rebranded the company as Genetix. He says the transaction rescued the firm from the brink of bankruptcy and set it on a pa…
    STAT · 1mo agoDealPositive↗ source
  • Elevance Health sues CMS, claiming $115 million loss from disputed Medicare Advantage star rating recalculation
    Elevance Health filed a lawsuit in the U.S. District Court for the Southern District of Georgia, alleging that the Centers for Medicare & Medicaid Services (CMS) recalculated its Medicare Advantage…
    STAT · 1mo agoRegulatoryNegative↗ source
  • CDC leadership accused of stifling vaccine effectiveness studies and reshaping advisory committee role
    Ben Lopman, a professor of epidemiology and global health at Emory University, wrote an opinion piece warning that CDC leadership is trying to manufacture a scientific debate about vaccines where n…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Protillion Biosciences appoints Robert Hollingsworth as chief scientific officer
    Protillion Biosciences announced the hiring of Robert Hollingsworth as its new chief scientific officer. Hollingsworth joins Protillion after serving as chief scientific officer at Shoreline Therap…
    STAT · 1mo agoNeutral↗ source
  • Loss of Colorado Rep. Diana DeGette removes a knowledgeable voice for biopharma in Congress
    Colorado Democratic Rep. Diana DeGette was defeated in her primary, ending her service in the U.S. House of Representatives. DeGette was widely recognized for her deep understanding of biopharma p…
    STAT · 1mo agoNegative↗ source
  • Teen use of AI mental-health chatbots jumps 40% in a year, experts call for safety rules
    A recent study published in JAMA Pediatrics found that the proportion of adolescents turning to AI chatbots for mental-health advice rose from roughly one in eight to one in five within a single ye…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Heat waves become more frequent and intense, raising health risks for Americans as presidential fitness test returns
    Recent data show that heat waves across the United States are occurring more often, lasting longer, and reaching higher temperatures, which experts say could increase health problems such as heat e…
    STAT · 1mo agoNeutral↗ source
  • Presidential fitness test returns as a modest push for youth activity, experts caution limits
    The health secretary reintroduced a presidential fitness test as part of a campaign to boost youth health and address rising sedentary habits. Experts say the test is a positive step but not a com…
    STAT · 1mo agoNeutral↗ source
  • FDA approves Orca Bio's T-cell therapy to lower graft-versus-host disease risk in blood cancer transplants
    The FDA gave its nod to Orca Bio's personalized T-cell therapy, Tregzi, aimed at patients with blood cancers undergoing stem cell transplants. The therapy is designed to cut the chance of chronic…
    STAT · 1mo agoApprovalPositive↗ source
  • Study finds statins and blood-pressure meds bring middle-aged obese adults' heart risk markers in line with normal-weight peers
    A new 25-year observational study published in The Lancet shows that adults over 40 with obesity have blood‑pressure and cholesterol levels comparable to those of normal‑weight individuals. Resear…
    STAT · 1mo agoPositive readoutPositive↗ source
  • Ipsen to acquire Swiss biotech Memo Therapeutics in up to €800 million deal for BK virus drug
    Ipsen announced it will purchase Memo Therapeutics, a Swiss biotech, in a transaction valued at up to about €800 million. The agreement provides Memo investors with €200 million upfront and potent…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Abivax shares jump 40% after Phase 3 data show no excess cancer risk for ulcerative colitis drug
    Abivax reported new safety data from its Phase 3 trial of obefazimod in ulcerative colitis. The data indicated malignancy rates among trial participants were comparable to background rates observed…
    BioPharma Dive · 1mo agoPositive↗ source
  • Ebola and Marburg outbreaks highlight need for pathogen-agnostic diagnostics
    The authors describe a current Bundibugyo Ebola outbreak affecting the Democratic Republic of Congo and Uganda, which has resulted in more than 1,300 confirmed cases and over 375 deaths. While the…
    STAT · 1mo agoNegative↗ source
  • BridgeBio secures up to $1 billion in preferred equity as United Therapeutics invests $140 million to acquire Thymmune
    BridgeBio Pharma announced that Sixth Street Partners and HealthCare Royalty will provide up to $1 billion in preferred equity to support its upcoming product launches. The financing is structured…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • Biotech Scorecard Q3 Highlights Upcoming Trial Readouts from Amylyx and Biogen
    STAT’s quarterly biotech scorecard lists fifteen events that could move biotech stocks, focusing on trial readouts and other milestones. Amylyx Pharmaceuticals reported results from its Phase 3 LU…
    STAT · 1mo agoNeutral↗ source
  • Researchers claim creation of first fully synthetic cell, launch public benefit corporation to share technology
    Researchers at the University of Minnesota reported in a preprint that they have built what they call a synthetic cell, dubbed "SpudCell," which they suggest may be the first of its kind. The team…
    STAT · 1mo agoPositive↗ source
  • Anthropic launches Claude Science AI tool for pharma research labs
    Anthropic announced the availability of Claude Science, an application that tailors its large language model for use in scientific laboratories and pharmaceutical research operations. The tool is…
    STAT · 1mo agoPositive↗ source