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3,014 stories matching this filter · ← front page

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  • 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 · 19d agoApprovalPositive↗ source
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  • 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 · 19d agoNegative↗ 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 · 19d 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 · 19d 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 · 19d 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
  • 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
  • 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 · 19d 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 · 19d 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 · 19d agoNeutral↗ source
  • Mark Cuban's Cost Plus Drugs targets rare disease market with custom n-of-1 therapies
    Mark Cuban's Cost Plus Drugs, known for low-cost generics, is expanding into rare disease treatments. The company has dedicated part of its new manufacturing plant to producing custom "n-of-1" the…
    STAT · 20d agoPositive↗ source
  • Crossover fundraisings may hit $4.2 billion in 2026, with 2025 rounds still leading historic totals
    Crossover rounds are viewed as a bridge to public markets, with Jim Healy of Sofinnova Investments saying a large raise signals a company has reached a level of maturity and broader institutional i…
    BioSpace · 20d agoDealNeutral↗ source
  • Isomorphic Labs' soaring valuation sparks debate over AI’s impact on drug development and healthcare costs
    Isomorphic Labs, a biotech spin‑out that applies generative AI to design new medicines, recently secured a multi‑billion‑dollar valuation that has captured industry attention. The lofty figure is…
    STAT · 19d agoNeutral↗ source
  • FDA device officials prioritize hiring after layoffs, express optimism for upcoming MDUFA VI agreement
    Top officials from the FDA's Center for Devices and Radiological Health spoke at a town‑hall session during The MedTech Conference. They said the agency is concentrating on rebuilding staff after a…
    raps · 20d agoRegulatoryPositive↗ source
  • ADA chief scientific officer Rita Kalyani departs amid ongoing review of New Orleans incident
    The American Diabetes Association announced Tuesday that its chief scientific and medical officer, Dr. Rita Kalyani, is no longer in her role, effective immediately. The move comes as the ADA cont…
    STAT · 19d agoNegative↗ source
  • Rising US measles cases highlight need for door-to-door public health outreach
    The United States is experiencing its largest measles outbreak in more than 30 years, with over 4,400 confirmed cases and more than a thousand people sickened so far this year. Pennsylvania alone h…
    STAT · 20d agoNegative↗ source
  • Experts suggest emphasizing measles survival rates to boost vaccine trust
    The United States has reported more than 4,400 measles cases this year, roughly twice the number recorded in 2025. At the same time, vaccination rates have fallen in over 1,600 counties between 201…
    STAT · 20d agoNeutral↗ source
  • Pharma companies push FDA for risk-based flexibility in container-closure testing guidance
    Major pharma firms have written to the FDA urging a shift in its current guidance on testing container-closure systems for drug and biologic products. They argue that a risk-based, flexible approa…
    raps · 20d agoRegulatoryNeutral↗ source
  • NIH Scales Back Replication Initiative, Critics Warn It Undermines Scientific Rigor
    NIH originally announced a push to make replication a core part of biomedical research, including an $850,000 Replication Prize launched in March 2025. Health secretary Robert F. Kennedy Jr. sugge…
    STAT · 20d agoNegative↗ source
  • CMS expands fraud crackdown to New York adult day-care program, calls it a "plague to the state"
    CMS announced it will use its new authority to remove providers from federal health programs, focusing on adult day-care centers in New York City. The agency says the Social Adult Day Care (SADC)…
    STAT · 19d agoRegulatoryNegative↗ source
  • Eight biopharma companies posting dozens of remote job openings
    BioSpace compiled a list of eight biopharma firms currently advertising remote positions for life‑science professionals. The companies together have roughly 300 openings, ranging from strategic ac…
    BioSpace · 19d agoNeutral↗ source
  • Companies price the role, not the employee, says executive coach on compensation expectations
    Executive coach Angela Justice argues that firms usually set pay based on the value of the job itself rather than the individual who fills it. She says this distinction is often clear in theory but…
    BioSpace · 20d agoNegative↗ source
  • FDA approves Hibsago, first antisense therapy for chronic hepatitis B
    The U.S. Food and Drug Administration has approved Hibsago (bepirovirsen) injection to be used alongside existing antiviral therapy for chronic hepatitis B virus infection in certain adults without…
    fda press · 20d agoApprovalPositive↗ source