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  • 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 · 19h agoNegative↗ source
  • Gerresheimer sells Centor and Primary Packaging Plastics units to Apax Partners for €1.5 billion
    Gerresheimer announced it is divesting two of its businesses, the Centor unit and the Primary Packaging Plastics (PPP) unit, to private‑equity firm Apax Partners. The transaction is valued at rough…
    Endpoints · 14h agoDealNeutral↗ source
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  • 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 · 19h 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 · 14h 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 · 19h agoNegative↗ source
  • Red Bull-funded studies downplay risks of mixing energy drinks with alcohol, shaping policy despite independent warnings
    An investigative report found that research funded by the energy‑drink maker contradicted the bulk of independent studies on the dangers of combining alcohol with caffeinated beverages. The funded…
    STAT · 1d agoRegulatoryNegative↗ source
  • Trump's CDC nominee Erica Schwartz clears key Senate committee vote
    Erica Schwartz, a former deputy surgeon general, was nominated by the Trump administration to lead the CDC. On July 15, 2026 she testified before the Senate Health, Education, Labor and Pensions C…
    Endpoints · 12h agoRegulatoryNeutral↗ source
  • Recon: FDA adcomm votes against Capricor’s DMD drug; Cytokinetics gets UK approval, NICE backing for heart drug
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 1d ago↗ source
  • Euro Roundup: EFPIA pushes for shorter trial approval times in EU Biotech Act
    EFPIA has called for lawmakers to go beyond the reductions in clinical trial approval times proposed in the Biotech Act.
    raps · 1d ago↗ source
  • FDA updates product-specific guidelines for injectable peptides
    The US Food and Drug Administration (FDA) has updated 17 draft product-specific guidances (PSGs) to assist sponsors in submitting abbreviated new drug applications (ANDAs) for injectable peptide pr…
    raps · 1d ago↗ source
  • Researchers concerned by underutilization of accelerated approval in oncology
    Most adult cancer drugs approved by the US Food and Drug Administration (FDA) over the past two decades were regular approvals for expanded indications based on surrogate endpoints, rather than acc…
    raps · 1d ago↗ source
  • FDA unveils FY 2027 user fee rates
    The US Food and Drug Administration (FDA) has published its user fee rates for FY 2027 across its prescription drug, generic drug, biosimilar, medical device, and over-the-counter drug programs. Th…
    raps · 1d ago↗ source
  • FDA reviewers doubt Replimune’s melanoma therapy as shares tumble 40%
    Replimune's shares fell nearly 40% after FDA reviewers released briefing documents expressing skepticism about its experimental melanoma drug RP1. RP1 has been rejected twice before; the company l…
    BioPharma Dive · 1d agoRegulatoryNegative↗ source
  • FDA advisory panel rejects Capricor's Duchenne heart-cell therapy deramiocel
    An FDA advisory committee voted 9-3 to reject Capricor Therapeutics' experimental cell therapy deramiocel for Duchenne-related cardiomyopathy. The panel said the data did not provide substantial ev…
    BioPharma Dive · 1d agoRegulatoryNegative↗ source
  • MapLight Therapeutics' mid-stage schizophrenia trial shows modest improvement but shares plunge two-thirds
    MapLight Therapeutics announced that its experimental schizophrenia drug met its primary endpoint in a mid-stage study, delivering an average 4.5‑point reduction on the PANSS symptom scale after fi…
    BioPharma Dive · 1d agoNegative readoutNegative↗ source
  • Latigo's mid-stage trial shows non-opioid pill LTG-001 cuts post-surgery pain, outperforms placebo
    Latigo Biotherapeutics reported positive Phase 2 data for its experimental oral analgesic LTG-001, tested in patients who had undergone tummy-tuck surgery. The study enrolled 343 participants who w…
    STAT · 1d agoPositive readoutPositive↗ source
  • FTC sues Hims & Hers over alleged health data sharing and deceptive billing practices
    The Federal Trade Commission filed a lawsuit against Hims & Hers, a telehealth company based in San Francisco, accusing it of improper handling of patient information. According to the complaint,…
    Endpoints · 1d agoRegulatoryNegative↗ source
  • US releases $600M pledged to global vaccine alliance Gavi after year‑long delay
    The United States has released the $600 million it pledged to Gavi, the global vaccine alliance. The funds had been held in limbo for about a year before the Treasury completed the transfer. Sena…
    Endpoints · 1d agoDealPositive↗ source
  • FDA and Capricor clash over Duchenne cell therapy efficacy at advisory committee
    At an FDA advisory committee meeting, the agency and Capricor Therapeutics presented conflicting views on the efficacy data for the company's experimental cell therapy aimed at Duchenne muscular dy…
    Endpoints · 1d agoRegulatoryNegative↗ source
  • Vertex and AbCellera team up to develop next-generation T-cell engagers for autoimmune diseases
    Vertex Pharmaceuticals has entered a partnership with AbCellera to create next-generation T-cell engagers aimed at autoimmune diseases. AbCellera will receive an upfront payment of $28 million, wit…
    BioPharma Dive · 1d agoDealPositive↗ source
  • Atea's hepatitis C combo therapy shows non-inferior results to Gilead's Epclusa
    Atea Pharmaceuticals announced that its oral combination of bemnifosbuvir and ruzasvir met the predefined non-inferiority criteria when compared with Gilead's Epclusa for treating hepatitis C. The…
    Endpoints · 1d agoPositive readoutPositive↗ source
  • Trump administration ends Medicare drug plan subsidies, raising cost concerns ahead of midterms
    The White House announced that subsidies for private Medicare prescription drug plans will be discontinued, a move expected to increase premiums for many seniors. The policy shift comes as Democra…
    STAT · 1d agoRegulatoryNegative↗ source
  • Benchmarking Clinical LLMs Proves Complex After Recent Nature Medicine Study
    The STAT AI Prognosis newsletter, written by health‑tech reporter Brittany Trang, looks at why evaluating new clinical large language models is difficult. A recent Nature Medicine paper compared s…
    STAT · 1d agoNeutral↗ source
  • Leqembi posts $184M Q2 sales, best quarter since launch, Biogen lifts guidance
    Leqembi, the anti-amyloid Alzheimer’s drug co-developed by Eisai and Biogen, generated $184 million in global sales in the second quarter, according to Biogen. The Q2 figure represents the stronge…
    Endpoints · 1d agoEarningsPositive↗ source
  • Former VA Secretary argues the Veterans Health Administration can boost US biotech competitiveness against China
    The piece, authored by former Veterans Affairs Secretary David Shulkin, positions the VA as a critical component of America’s biotechnology ecosystem alongside HHS and the Department of Defense. H…
    STAT · 1d agoNeutral↗ source