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  • Fauci warns of public "selective amnesia" on Covid, hints at upcoming book as STAT newsletter covers Trump drug pricing deals
    STAT's twice‑weekly D.C. Diagnosis newsletter continues to blend health policy analysis with behind‑the‑scenes commentary, offering readers insight into current political debates. In a recent inte…
    STAT · 9d agoNeutral↗ source
  • HHS reverses stance on disability lawsuit amid reports of falling overdose deaths and AI device access
    The Department of Health and Human Services has changed its position on a pending disability lawsuit, signaling a shift in its legal strategy. Data released this year show a sharp decline in U.S.…
    STAT · 9d agoRegulatoryNeutral↗ source
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  • BioSpace lists top 12 biopharma employers hiring in July 2026
    BioSpace released a list of the twelve biopharma firms with the most job postings in July 2026. The list includes AbbVie, Regeneron, Amgen, Eli Lilly, Sanofi, Novo Nordisk, Moderna, Insmed, Freder…
    BioSpace · 9d agoNeutral↗ source
  • GE HealthCare updates use instructions for Portrait Mobile monitoring software after FDA safety alert
    GE HealthCare has sent a letter to customers using its Portrait Mobile Monitoring Solution devices, advising updated instructions for certain versions of the Portrait Core Services software. The F…
    fda medwatch · 9d agoCRLNeutral↗ source
  • UK government proposes legal amendments to modernize medicines and medical device regulations
    The UK government has introduced a set of legal amendments aimed at updating the framework that governs medicines and medical devices. The changes are intended to streamline approval processes, in…
    raps · 9d agoRegulatoryNeutral↗ source
  • Pediatricians Offer 'Last Resort' Care for Vaccine-Skeptical Parents
    A small group of pediatricians across six states have created what they call a "practice of last resort" for families hesitant about vaccines. Rather than turning patients away, they focus on liste…
    STAT · 9d agoNeutral↗ source
  • Former doula turned OB‑GYN calls for better understanding between the two professions
    Debra Eluobaju, a maternal‑fetal medicine fellow who previously worked as a doula, reflects on the gap between doulas and obstetricians. She argues that many conflicts in maternity care stem from s…
    STAT · 9d agoNeutral↗ source
  • Novartis and BMS pause CAR‑T trials after patient deaths while Revolution Medicines gains early FDA approval for pancreatic cancer drug
    Novartis has placed several trials of its CAR‑T therapy rapcabtagene autoleucel on hold after three patients receiving the treatment died. Bristol Myers Squibb also voluntarily froze its autoimmun…
    BioSpace · 10d agoRegulatoryNeutral↗ source
  • BMS faces steep risk if milvexian trial fails, could spark mega-cap merger frenzy
    BMS is heading toward a readout for its oral FXIa inhibitor milvexian, a trial that analysts say could be pivotal for the company's future growth. The recent collapse of merger talks with AstraZen…
    BioSpace · 10d agoNegative readoutNegative↗ source
  • FDA to tighten oversight of foreign clinical trial sites as China trial volume soars
    FDA officials wrote an editorial stating that inspection access is not an administrative footnote and announced plans to expand oversight of foreign clinical trial sites. The initiative follows th…
    BioSpace · 10d agoRegulatoryNeutral↗ source
  • Beyond GLP-1s: Companies eye new obesity drug mechanisms as efficacy plateaus
    The obesity drug market continues to expand, with GLP-1 therapies growing from about $5.5 billion in 2023 to over $55 billion projected for 2033. These agents are used for weight loss, diabetes and…
    BioSpace · 10d agoNeutral↗ source
  • Ultragenyx's Angelman syndrome drug fails in Phase 3 trial, showing no benefit
    Ultragenyx announced that its experimental therapy GTX-102 for Angelman syndrome did not demonstrate any benefit compared with a sham control in a large Phase 3 trial. The drug had previously show…
    STAT · 10d agoNegative readoutNegative↗ source
  • Novartis and Bristol Myers pause autoimmune CAR-T trials after serious safety events
    Novartis and Bristol Myers Squibb announced the suspension of several autoimmune CAR‑T studies after encountering serious safety problems. In Novartis' trials, three participants died from a severe…
    BioPharma Dive · 10d agoNegative readoutNegative↗ source
  • UniQure files FDA priority review request for Huntington’s gene therapy AMT-130
    UniQure, a Dutch biotech, announced on Wednesday that it has submitted applications to the U.S. Food and Drug Administration seeking a priority review for its gene therapy AMT-130, which targets th…
    BioPharma Dive · 10d agoRegulatoryNeutral↗ source
  • UniQure submits FDA and UK applications for first Huntington’s disease gene therapy
    UniQure has filed a biologics license application (BLA) with the U.S. FDA and a separate submission with the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its experimental gene…
    BioSpace · 10d agoRegulatoryNeutral↗ source
  • UK regulator suspends new patients from receiving Tavneos (Avacopan Vifor) amid data concerns
    The UK Medicines and Healthcare products Regulatory Agency (MHRA) has decided to stop prescribing Tavneos, known locally as Avacopan Vifor, to any new patients. The decision follows the regulator’…
    BioSpace · 10d agoRegulatoryNegative↗ source
  • Medline expands recall of reprocessed electrophysiology and ultrasound catheters due to contamination risk
    Medline Industries has issued an expanded recall that adds new lots of reprocessed electrophysiology and ultrasound catheters after the FDA identified possible residual particulates in the devices.…
    fda medwatch · 10d agoCRLNegative↗ source
  • Teva reports positive mid-stage results for celiac disease antibody, BioMarin settles patent fight with Ascendis
    Teva said its experimental antibody TEV-408 showed statistically significant and clinically meaningful reduction in gluten-induced intestinal damage in a mid-stage trial for celiac disease. The tr…
    BioPharma Dive · 10d agoPositive readoutPositive↗ source
  • UniQure submits experimental Huntington's gene therapy to FDA for accelerated review
    UniQure announced that it has filed its experimental gene therapy for Huntington's disease with the U.S. Food and Drug Administration, seeking accelerated approval. The submission follows earlier…
    STAT · 10d agoRegulatoryNeutral↗ source
  • Novartis’ BTK inhibitor remibrutinib cuts MS relapse rates in Phase 3, setting up FDA filing
    Novartis reported that its BTK inhibitor remibrutinib, already approved for chronic spontaneous urticaria, lowered annualized relapse rates in two Phase 3 studies of relapsing multiple sclerosis wh…
    BioSpace · 10d agoPositive readoutPositive↗ source
  • Trump’s new pharma deals lower Medicaid prices but shield Medicare from cuts
    Washington officials announced new voluntary pricing agreements with several midsize biotechnology companies. The deals require the firms to reduce the prices they charge under Medicaid, the progra…
    STAT · 10d agoDealNegative↗ source
  • Funding announcements can hint at upcoming biotech hiring opportunities
    Funding announcements serve as early signals that a biotech company may soon expand its workforce, giving job seekers a chance to reach out before roles are formally posted. Alex Benjamin, vice pr…
    BioSpace · 10d agoNeutral↗ source
  • Medical groups issue new flu, Covid and RSV vaccination guidance for upcoming winter season
    Professional organizations representing pediatricians, family physicians, obstetricians and other clinicians released joint vaccination guidelines on Wednesday for the upcoming respiratory illness…
    STAT · 10d agoNeutral↗ source
  • ARPA-H grants funding to biotech firms developing custom RNA therapies amid broader biotech updates
    ARPA-H is providing grants to several biotech companies to develop custom RNA therapeutics, aiming to accelerate personalized medicine. Roche has licensed a tri‑specific antibody, adding a new mod…
    STAT · 10d agoNeutral↗ source
  • Biotech reverse mergers surge 1,600% in Q3, matching number of IPOs in 2026
    Biotech companies are turning to reverse mergers as a faster, less volatile route to the public markets. In the third quarter of 2026, 17 reverse mergers were completed or announced, a 1,600% incre…
    BioSpace · 10d agoDealNeutral↗ source