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  • Abivax remains independent despite intense acquisition speculation
    Biotech merger activity is at record levels, yet the French company Abivax, which is developing the ulcerative colitis drug obefazimod, has not been bought. Rumors have floated about a potential $…
    STAT · 2mo agoDealNegative↗ source
  • Superluminal Medicines raises $60M Series B to launch Phase 1 trial of genetic obesity therapy
    Superluminal Medicines, a Boston‑based biotech, announced it has closed a $60 million Series B financing round. The capital will fund the company’s first‑in‑human study of its genetic obesity candi…
    Endpoints · 2mo agoDealNeutral↗ source
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  • Overdose deaths fall sharply in US and abroad, report links decline to naloxone and harm-reduction measures
    A new report highlights a sudden drop in drug overdose deaths after years of consistently high numbers in the United States. The data show that U.S. deaths fell 27% in 2024 and preliminary figures…
    STAT · 2mo agoNeutral↗ source
  • Ultragenyx's Angelman syndrome drug fails Phase 3 trial, halting development
    Ultragenyx reported that its experimental antisense oligonucleotide designed for Angelman syndrome did not meet primary endpoints in a Phase 3 study. The trial, which enrolled patients with the ra…
    Endpoints · 2mo agoNegative readoutNegative↗ source
  • CBER official overturns Replimune melanoma drug rejection; AbbVie reports phase 3 success in multiple myeloma
    A CBER regulator has reversed a prior decision to reject Replimune's experimental melanoma therapy, allowing the program to move forward. AbbVie announced that its multiple myeloma candidate achie…
    raps · 2mo agoRegulatoryNeutral↗ source
  • FDA grants emergency use authorization for Capstar and generic nitenpyram to prevent and treat New World screwworm in dogs and cats
    The U.S. Food and Drug Administration issued an Emergency Use Authorization for Capstar (nitenpyram) tablets and updated the EUA for the generic Nitenpyram Tablets. Both products are now authorized…
    fda press · 2mo agoRegulatoryPositive↗ source
  • FDA’s Biologics Branch Scores Wins Against Unproven Stem Cell Clinics, Says Expert
    Professor Paul Knoepfler, a cell‑biology professor at UC Davis, writes that the FDA’s biologics division has recently taken concrete steps to curb the proliferation of unproven stem‑cell clinics in…
    STAT · 2mo agoRegulatoryPositive↗ source
  • FDA launches TEMPO pilot to let generative AI medical devices reach patients before formal approval
    The Food and Drug Administration has opened a new pilot program called TEMPO that permits certain generative‑AI medical devices to be made available to patients even though they have not received f…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • Industry urges FDA to broaden prior-knowledge guidance for gene and cell therapies
    Industry groups have asked the U.S. Food and Drug Administration to broaden its draft guidance on the use of scientifically valid prior knowledge in developing gene therapies that involve genome ed…
    raps · 2mo agoRegulatoryNeutral↗ source
  • New cardiovascular guidelines released for tactical athletes such as EMTs, firefighters and police
    The American College of Cardiology and the American Heart Association issued new cardiovascular guidance aimed at clinicians who treat "tactical athletes," a term that includes emergency responders…
    STAT · 2mo agoRegulatoryPositive↗ source
  • Pfizer grants Medicus co-development rights to CD228-targeted ADC PF-08046031
    Pfizer announced it is transferring co-development rights for its CD228-targeted antibody-drug conjugate, PF-08046031, to Medicus Pharma. The ADC, originally discovered by Seagen, will now be adva…
    Endpoints · 2mo agoDealNeutral↗ source
  • OpenEvidence introduces new family of AI models for health tech
    OpenEvidence announced a new family of artificial intelligence models aimed at health technology applications, as reported in STAT's Health Tech newsletter. The announcement highlights the company'…
    STAT · 2mo agoPositive↗ source
  • Novartis licenses Alteogen’s hyaluronidase enzyme ALT-B4 in new drug delivery partnership
    Novartis announced a licensing agreement with South Korean biotech Alteogen to use its hyaluronidase enzyme ALT-B4 for drug delivery applications. The enzyme will be produced using Alteogen’s prop…
    Endpoints · 2mo agoDealNeutral↗ source
  • 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 · 2mo 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 · 2mo agoRegulatoryNeutral↗ 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 · 2mo 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 · 2mo 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 · 2mo agoNeutral↗ source
  • Deaths of two Chinese children receiving CRISPR therapy spark safety debate
    Two children in China died after receiving experimental CRISPR-based gene therapies, according to a recent report. The fatalities have unsettled researchers in the United States who are developing…
    Endpoints · 2mo agoRegulatoryNegative↗ 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 · 2mo agoNegative readoutNegative↗ source
  • Novartis CAR-T trial deaths spark safety concerns for autoimmune applications
    Novartis disclosed that three participants in its CAR-T cell therapy trials for autoimmune disease have died. The company said the deaths were reported to health authorities and are under investiga…
    Endpoints · 2mo agoRegulatoryNegative↗ 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 · 2mo agoNegative readoutNegative↗ source
  • FDA CBER director overrides review team to grant accelerated approval for Replimune's melanoma therapy Tudriqev
    A senior official at the FDA's Center for Biologics Evaluation and Research stepped in to reverse a prior rejection by the agency's review panel. The director of the office of clinical evaluation a…
    Endpoints · 2mo agoApprovalPositive↗ 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 · 2mo agoRegulatoryNeutral↗ source
  • FDA vows tighter review of foreign clinical trial data amid rising Chinese influence
    Top FDA officials announced that the agency will intensify its oversight of clinical trial data generated outside the United States. The move is aimed at ensuring that foreign data meet the same st…
    Endpoints · 2mo agoRegulatoryNeutral↗ source