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  • Novo Nordisk's heart drug ziltivekimab fails Phase 3 trial, raising doubts on inflammation-targeted therapies
    Novo Nordisk announced that its experimental cardiovascular drug ziltivekimab did not meet the primary endpoint in a Phase 3 study. The trial was designed to see if the drug could lower the inciden…
    BioPharma Dive · 5h agoNegative readoutNegative↗ source
  • Novo Nordisk's anti-inflammatory drug ziltivekimab fails to cut major heart events in Phase 3 trial
    Novo Nordisk reported that its investigational anti‑inflammatory antibody, ziltivekimab, did not reduce the incidence of major cardiovascular events in a pivotal Phase 3 study. The trial enrolled…
    STAT · 9h agoNegative readoutNegative↗ source
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  • Sanofi CEO pledges to rebuild trust and expand partnership with Regeneron
    Sanofi's new chief executive, Belén Garijo, told analysts that restoring the relationship with longtime partner Regeneron is a top priority. She said the company wants to be more transparent and to…
    BioPharma Dive · 6h agoNeutral↗ source
  • FDA advisory panel backs experimental Replimune melanoma therapy after two prior rejections
    An FDA advisory committee voted 10‑to‑3 to recommend the use of an experimental Replimune treatment for patients with advanced melanoma. The panel’s recommendation marks a shift after the agency p…
    STAT · 8h agoPositive readoutPositive↗ source
  • Trump administration revises 340B rebate pilot, sparking hospital backlash
    The Health Resources and Services Administration announced a revision to the 340B drug pricing program’s rebate pilot, slated to begin on Jan 1, 2027. Under the new rules, participating manufactur…
    STAT · 5h agoRegulatoryNegative↗ source
  • Senate advances Erica Schwartz’s CDC director nomination to full Senate vote
    The Senate Health Committee approved Erica Schwartz as the nominee for CDC director, securing bipartisan support that included every Republican member and Democrat Tim Kaine. With the committee’s…
    STAT · 9h agoRegulatoryNeutral↗ source
  • Opinion: Limb girdle muscular dystrophy patients face a maddening reality
    “Too often, regulatory tools authorized to speed patient access to breakthrough treatments are being used in ways that even prevent approval,” writes Kat Bryant Knudson.
    STAT · 13h agoRegulatoryNeutral↗ source
  • Syphilis cases rise among unhoused drug users at San Diego-Tijuana border as researchers face NIH limits and penicillin shortage
    Researchers at the University of California San Diego have been working for years to build trust with unhoused people who use drugs on both sides of the San Diego‑Tijuana border. Their outreach has…
    STAT · 13h agoNegative↗ source
  • ADA’s reputation erodes after controversial physician expulsions at annual meeting
    In a recent opinion piece, Adam Marcus and Ivan Oransky reflect on how their view of the American Diabetes Association (ADA) has shifted. Nine years ago they lauded the organization for defending a…
    STAT · 13h agoNegative↗ source
  • Authors rebut mischaracterization of their 2023 Lancet Covid study in recent op-ed
    The authors of a 2023 Lancet analysis on the United States Covid response wrote to correct a recent First Opinion piece that they say misrepresented their work. While they welcome calls for additio…
    STAT · 13h agoNegative↗ source
  • Bexorg names Bruce Car as new chief scientific officer
    Bexorg announced the appointment of Bruce Car as its chief scientific officer, according to a recent STAT+ column that tracks personnel moves in the pharmaceutical sector. Car joins Bexorg to lead…
    STAT · 7h agoPositive↗ source
  • Alnylam shares tumble nearly 30% after cutting revenue outlook for key amyloidosis drugs
    Alnylam Pharmaceuticals saw its market value drop about 30%, roughly $12 billion, after it lowered its revenue forecast for its leading amyloidosis treatments. The company had previously expected…
    BioPharma Dive · 1d agoEarningsNegative↗ source
  • Johnson & Johnson secures option to acquire in-vivo CAR-T developer Sail Biomedicines for up to $2.6 billion
    Johnson & Johnson announced a strategic partnership with Sail Biomedicines, a Flagship Pioneering‑backed startup, that includes an upfront cash payment and an equity investment. The initial paymen…
    BioPharma Dive · 1d agoDealPositive↗ source
  • FDA advisory panel backs Replimune's melanoma therapy RP1, raising approval prospects
    Advisors to the U.S. Food and Drug Administration voted 10-3 in favor of Replimune's experimental melanoma treatment, RP1, despite lingering scientific concerns about the data presented. The panel…
    BioPharma Dive · 1d agoRegulatoryPositive↗ source
  • FTC Sues Hims & Hers for Alleged Illegal Sharing of Patient Data and Deceptive Billing
    The Federal Trade Commission has filed a lawsuit against Hims & Hers, a California‑based telehealth company, accusing it of violating privacy laws. The complaint says the firm used tracking pixels…
    BioPharma Dive · 1d agoRegulatoryNegative↗ source
  • Rising oil prices could lift manufacturing costs of an HIV drug, Unitaid report says
    Rising oil prices, driven in part by geopolitical tensions, have raised concerns about the stability of medicine supply chains. Analysts note that higher energy costs can translate into increased p…
    STAT · 1d agoNeutral↗ source
  • FDA panel rejects Capricor's Duchenne drug, citing insufficient efficacy data
    The U.S. Food and Drug Administration advisory committee voted 9-to-3 against a Capricor Therapeutics candidate for Duchenne muscular dystrophy. The panel said the clinical data did not provide sub…
    STAT · 1d agoRegulatoryNegative↗ source
  • Ebola cases approach key milestone as vaccine candidates draw near completion
    The latest update on the Ebola outbreak indicates that the number of cases is approaching a significant threshold, while vaccine development efforts are reported to be close to delivering a usable…
    STAT · 1d agoNeutral↗ source
  • Senate health panel confirms Trump picks for CDC director and pandemic preparedness chief
    The Senate health committee approved two Trump administration nominees for key health positions on Thursday. Erica Schwartz was confirmed as CDC director with bipartisan support from all Republica…
    STAT · 1d agoRegulatoryNeutral↗ source
  • FDA advisory panel reviews Replimune's experimental melanoma therapy RP1
    STAT is live-blogging an FDA Cellular, Tissue, and Gene Therapies Advisory Committee meeting that convened on Thursday to examine Replimune's engineered viral immunotherapy RP1 for melanoma. The p…
    STAT · 1d agoRegulatoryNeutral↗ source
  • Podcast debates FDA’s handling of Duchenne drugs and upcoming executive changes
    Allison DeAngelis, Adam Feuerstein and Elaine Chen host this week’s Readout Loud podcast, a STAT series that examines biotech trends and business moves. The trio questions whether the FDA is apply…
    STAT · 1d agoNeutral↗ source
  • Experts warn U.S. pharma reliance on China poses national security threat
    The authors of a recent Council on Foreign Relations report argue that the United States’ dependence on China for biopharmaceutical manufacturing creates a clear national security risk. They point…
    STAT · 1d agoNegative↗ source
  • Medicaid work rules spark confusion over medically frail exemption, risking coverage for chronically ill
    Nebraska will begin enforcing Medicaid work requirements next week, demanding that beneficiaries work, volunteer or attend school for at least 80 hours each month or risk losing their health covera…
    STAT · 1d agoRegulatoryNegative↗ source
  • Federal judge rejects 26 states' bid to delay Medicaid work requirement rollout
    A U.S. District Judge in Massachusetts issued an order Thursday refusing to grant a preliminary injunction that would have paused the new Medicaid work‑requirement rules. The decision leaves the fe…
    STAT · 1d agoRegulatoryNeutral↗ source
  • A decade after WHO recognition, mycetoma is still one of the world’s most neglected diseases
    Borna Nyaoke-Anoke, a physician leading mycetoma work at the Drugs for Neglected Diseases initiative, reflects on a decade since the World Health Organization formally acknowledged the disease. Sh…
    STAT · 1d agoNegative↗ source