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4,344 stories matching this filter · ← front page

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  • Gilead Sciences to Pay $45 Million to Settle Texas Medicaid Kickback Allegations
    Gilead Sciences has agreed to pay $45 million to settle claims by the Texas attorney general that the company provided illegal kickbacks that influenced prescriptions covered by Texas Medicaid. Th…
    STAT · 18d agoRegulatoryNegative↗ source
  • Nutrition experts urge White House to release ultra-processed food definition before midterms
    More than 80 nutrition researchers and experts have signed a petition urging the White House to make public the federal government’s proposed definition of ultra-processed foods. The group says the…
    STAT · 18d agoRegulatoryNeutral↗ source
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  • Key career moves that propelled three BioSpace 40 Under 40 honorees to biotech leadership
    BioSpace highlighted three members of its 40 Under 40 list, asking them to describe pivotal moments that shaped their biotech careers. Lex Johnson, chief platform officer at Dispatch Bio, said the…
    BioSpace · 19d agoPositive↗ source
  • EMA opens consultation on platform trial methodology; MHRA to recognize CE-marked devices indefinitely
    The European Medicines Agency is launching a public consultation to gather feedback on the methodological aspects of confirmatory platform clinical trials. The agency seeks input from researchers,…
    raps · 19d agoRegulatoryNeutral↗ source
  • Health policy crackdown warnings span from China to New York, says STAT newsletter
    STAT's D.C. Diagnosis newsletter highlights growing concerns about health policy crackdowns that could affect regions from China to New York. In a recent Ohio appearance, the vice president used a…
    STAT · 19d agoNeutral↗ source
  • Family's unnamed inherited disease finally identified, offering hope for future generations
    Miranda Pappas, a research methodologist, describes how an inherited condition affected several generations of her family without ever having a formal name. Doctors repeatedly referred to the illn…
    STAT · 19d agoPositive↗ source
  • Top MAHA adviser Calley Means resigns from White House ahead of midterm elections
    Calley Means, a senior adviser for the Make America Healthy Again (MAHA) initiative in the Trump administration, announced his resignation from the White House. Means had served first as a close a…
    STAT · 18d agoNeutral↗ source
  • Economist admits misreading ACA's cost-control promise and calls for reforms
    Dana P. Goldman, director of the USC Schaeffer Institute, recalls signing a 2009 letter with other economists urging Congress to pass the Affordable Care Act. He supported the bill because it promi…
    STAT · 19d agoNegative↗ source
  • GSK receives FDA approval for hepatitis B therapy that expands functional cure rates
    GSK announced that the U.S. Food and Drug Administration has granted approval for its hepatitis B drug. The agency said the treatment can achieve functional cures in a larger proportion of patient…
    STAT · 20d agoApprovalPositive↗ source
  • US patients skip half of new high-cost drugs as prices surge past $250K
    A new report from the Institute for Clinical and Economic Review and West Health finds that only about one-third of patients prescribed newly launched medicines actually fill them within 30 days, w…
    BioSpace · 20d agoNegative↗ source
  • GSK and Ionis receive FDA nod for hepatitis B therapy promising functional cure
    GSK and Ionis announced that the U.S. Food and Drug Administration has approved their hepatitis B drug bepirovirsen, now marketed as Hibsago. The therapy is intended for chronic hepatitis B patien…
    Endpoints · 20d agoApprovalPositive↗ source
  • FDA approves GSK‑Ionis hepatitis B functional cure, Hibsago, targeting undetectable virus after six months
    The FDA has approved bepirovirsen, an antisense oligonucleotide from GSK and Ionis, for chronic hepatitis B infection. It will be sold under the brand name Hibsago. The therapy is described as a f…
    BioSpace · 20d agoApprovalPositive↗ source
  • US biotech M&A surges as Chinese licensing deals dominate 2026 market
    Locust Walk reports that China now accounts for 58% of global licensing deal value in 2026, while the United States share has dropped to 26%. Despite the licensing shift, US biotech companies are…
    BioSpace · 20d agoDealPositive↗ source
  • Disc Medicine’s Phase 3 data revives rejected rare‑disease drug as China tightens biotech ownership rules
    Disc Medicine announced that its Phase 3 trial of a previously rejected rare‑disease therapy showed positive results, effectively rescuing the program and positioning it for another submission to t…
    BioSpace · 20d agoPositive readoutPositive↗ source
  • Novo reports 25% average weight loss in women using CagriSema, with greatest loss in premenopausal patients
    Novo's next-generation GLP-1 drug CagriSema showed substantial weight loss in women enrolled in the Phase 3 REDEFINE 1 trial. Women in the study lost about 25% of their body weight after 68 weeks,…
    BioSpace · 20d agoPositive readoutPositive↗ source
  • German biotech Immatics eyes pivotal Phase 3 readout after promising uveal melanoma cell therapy results
    Immatics, a German biotech founded 26 years ago, is focusing on cancer immunotherapy. Its lead candidate is an experimental cell therapy targeting uveal melanoma. Early Phase 1 data in 16 patients…
    STAT · 20d agoPositive↗ source
  • Rezera files for IPO to fund NLRP3 peripheral artery disease program
    Rezera, which rebranded from NodThera earlier this year, has entered the queue for an initial public offering. The filing, submitted on Wednesday, is intended to raise capital to support the compa…
    Endpoints · 19d agoDealPositive↗ source
  • Treasury to tighten scrutiny of China biotech acquisitions under upcoming rules
    Treasury Secretary Scott Bessent announced on Sept 9 2026 that the Treasury Department will issue new guidance that makes it harder for U.S. pharma companies to complete biotech deals in China. Th…
    Endpoints · 19d agoRegulatoryNegative↗ source
  • FDA cites Baxter’s inadequate oversight after repeated GMP violations at multiple plants
    The U.S. Food and Drug Administration has issued a warning letter to Baxter International, saying the company's leadership has failed to provide adequate oversight of its drug manufacturing operati…
    BioSpace · 19d agoRegulatoryNegative↗ source
  • CSL appoints former ViiV and GSK veteran Deborah Waterhouse as new CEO
    CSL announced that Deborah Waterhouse will become its chief executive. The appointment follows her departure from GSK, where she spent three decades. Waterhouse most recently led ViiV Healthcare,…
    Endpoints · 20d agoPositive↗ source
  • Alcon buys Neurotech for $550 million upfront
    Alcon, the Swiss eye‑care company, announced it has completed the acquisition of Neurotech Pharmaceuticals. The transaction includes an upfront cash payment of $550 million, with the possibility o…
    Endpoints · 20d agoDealNeutral↗ source
  • Roivant's autoimmune drug brepocitinib succeeds in two pivotal trials, paving way for 2027 filing
    Roivant Sciences said its autoimmune drug brepocitinib met primary goals in two pivotal studies. The trials, which evaluated the drug in separate autoimmune indications, showed statistically signi…
    Endpoints · 20d agoPositive readoutPositive↗ source
  • Mark Cuban’s Cost Plus Drugs plans to enter custom rare-disease drug market
    Mark Cuban says his company Cost Plus Drugs will expand beyond generic medicines into the custom‑made rare disease space. The firm, which currently buys generic drugs and sells them directly to con…
    STAT · 20d agoDealPositive↗ source
  • Roivant reports Lisraya beats placebo in Phase 3 trials for non-infectious uveitis
    Roivant and its spinout Priovant announced that Lisraya, an immune-modifying oral drug, showed statistically significant benefit over placebo in two Phase 3 trials for non-infectious uveitis. The…
    STAT · 20d agoPositive readoutPositive↗ source
  • Nigeria confirms travel-linked Ebola case tied to DRC outbreak
    Nigeria's Ministry of Health announced a confirmed Ebola infection in a traveler, marking the country's first case linked to the ongoing outbreak in the Democratic Republic of the Congo. The patie…
    STAT · 20d agoNeutral↗ source