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  • AI drug hunter Enveda raises $311M for late-stage obesity, inflammatory disease push
    Tech darling Enveda has raised a total of $845 million in the past six years. The latest funding round is intended to pave the way for an IPO someday.
    BioSpace · 1mo agoRegulatoryNeutral↗ source
  • Family’s struggle to receive cystic fibrosis medication highlights care gaps
    Stephanie Marquart in Knoxville, Tennessee, waited anxiously for a delivery to her home, refreshing the tracking page repeatedly as the package made its way to her doorstep. The episode, described…
    Endpoints · 1mo agoNegative↗ source
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  • Federal Court Issues Consent Decree Halting Gold Star Distribution's FDA-Regulated Shipments Over Unsanitary Warehouse
    The U.S. District Court for the District of Minnesota entered a consent decree on Sept. 21, 2026 that permanently enjoins Gold Star Distribution, Inc. and its owner Bassam Abu Samrah from distribut…
    fda press · 1mo agoRegulatoryNegative↗ source
  • Immunovant halts lupus program after Phase 2b trial fails to meet efficacy endpoints
    Immunovant announced that its anti‑FcRn drug imeroprubart (IMVT‑1402) did not achieve the primary endpoint in a Phase 2b study in patients with cutaneous lupus erythematosus. The double‑blind tria…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • US to End Personal Medication Import Loophole as New Customs Rule Takes Effect
    A new regulation will begin next month that ends the longstanding loophole allowing Americans to import prescription drugs by mail. The rule, reported by the Wall Street Journal, requires any medic…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Quorum Health moves to nonprofit status as its rural hospital chain faces insolvency
    Quorum Health, a chain of mostly rural hospitals owned by private-equity investors, is in the process of converting all 11 of its facilities to nonprofit status after years of financial strain that…
    STAT · 1mo agoRegulatoryNegative↗ source
  • ReCode Therapeutics appoints Heather Clark as CEO to lead cystic fibrosis and primary ciliary dyskinesia programs
    ReCode Therapeutics announced that Heather Clark will take over as chief executive officer, succeeding founder Shehnaaz Suliman. The transition was presented as a move to keep momentum after the co…
    BioSpace · 1mo agoPositive↗ source
  • STAT AI Prognosis newsletter tackles AI doomerism and offers guidance for health professionals
    The latest web edition of STAT’s AI Prognosis newsletter, authored by health tech reporter Brittany Trang, focuses on the growing chatter around AI doomerism. It aims to help readers cut through th…
    STAT · 1mo agoNeutral↗ source
  • Opinion: Mentally ill women need stronger support to become mothers
    Meg LeDuc writes in an opinion piece that maternal mental-health needs of women with serious psychiatric conditions have been largely ignored in the United States. She recounts her own history of…
    STAT · 1mo agoPositive↗ source
  • Viking Therapeutics’ VK2735 shows 17.7% weight loss in Phase 1 and maintains effect with less frequent dosing
    Viking Therapeutics reported Phase 1 results for its injectable GLP-1/GIP dual agonist VK2735, showing an average 17.7% reduction in body weight after 21 weeks of weekly dosing in a placebo-control…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • AI becomes core to biopharma R&D, driving efficiency and faster drug development
    AI is now regarded as essential to everyday operations in the biopharma sector, helping to reduce the time and cost of drug development. Pfizer CEO Albert Bourla said AI played a key role in integ…
    BioSpace · 1mo agoPositive↗ source
  • Amgen reports positive Phase 3 results for Sjögren's drug; Novartis announces $900M radioligand partnership
    Amgen said its CD40 ligand antagonist dazodalibep met the primary endpoint in a Phase 3 trial for Sjögren's syndrome, marking a notable achievement for the company. Novartis disclosed a $900 milli…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Novo aims to increase oral Wegovy manufacturing capacity tenfold by 2030
    Novo announced at its Capital Markets Day that it plans to expand the manufacturing capacity for its oral GLP-1 drug Wegovy by a factor of ten by the end of the decade. The company said about 1.5…
    BioSpace · 1mo agoPositive↗ source
  • Four biotech firms file for IPOs as 2026 biotech listing surge continues
    2026 has seen more than 25 biotech companies debut on public markets, marking the highest number of IPOs since 2021. The wave of listings has helped the sector recover from a slowdown in 2025. Fou…
    BioSpace · 1mo agoDealPositive↗ source
  • Roche’s enicepatide shows dose-dependent blood sugar and weight loss in Phase 2 diabetes trial
    Roche reported that its injectable GLP-1/GIP dual agonist enicepatide, acquired through the Carmot Therapeutics purchase, achieved reductions in blood glucose and body weight in a Phase 2 study of…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • HHS rolls out new FDA rule to allow non-animal testing methods in drug development
    The Department of Health and Human Services announced a new set of strategies aimed at shifting drug development away from animal testing toward human-based research methods. The FDA issued a fina…
    STAT · 1mo agoRegulatoryPositive↗ source
  • US officials launch probe into falling German drug prices amid EU pharma push for competitiveness
    US trade officials held a hearing on Tuesday about a possible investigation into the decline in Germany's payments for pharmaceuticals. Testimony presented arguments both supporting and opposing t…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Former FDA Commissioners Endorse Heidi Overton as Strong Choice to Lead Agency
    Two former FDA commissioners, Scott Gottlieb and Mark B. McClellan, wrote an opinion piece supporting Heidi Overton’s nomination to lead the agency. They note her confirmation hearing is set before…
    STAT · 1mo agoRegulatoryPositive↗ source
  • Vertex reports early kidney drug data, boosting hopes for broad label ahead of next year's pivotal readout
    Vertex Pharmaceuticals disclosed early data from its experimental kidney disease therapy inaxaplin, showing improvements on a urine-based biomarker. The drug demonstrated positive changes in two s…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Compass Therapeutics to file BLA for tovecimig despite FDA call for new trial
    Compass Therapeutics announced it will continue pursuing a biologics license application (BLA) for its bispecific antibody tovecimig aimed at advanced biliary tract cancer, even after the FDA sugge…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • Celldex's barzolvolimab meets Phase 3 goals but safety concerns emerge
    Celldex announced that its experimental chronic hives treatment, barzolvolimab, achieved the primary endpoint in two Phase 3 trials. The trials demonstrated the drug's efficacy in reducing hive sy…
    Endpoints · 1mo agoPositive readoutNeutral↗ source
  • Nvidia-backed Iambic Therapeutics files for IPO, unveils AI-driven pipeline
    Iambic Therapeutics, a San Diego biotech that uses artificial intelligence to discover medicines, announced it has filed a registration statement to become a publicly traded company. The filing ma…
    Endpoints · 1mo agoDealNeutral↗ source
  • Novo Nordisk may secure more favorable terms under Medicare’s Bridge obesity drug program
    Novo Nordisk and Eli Lilly have been profiting from a Medicare pilot that caps obesity drug prices for seniors at $245 a month. Recent analysis suggests Novo could negotiate an even better arrangem…
    STAT · 1mo agoRegulatoryPositive↗ source
  • Novo Nordisk cuts 13,000 jobs to redirect funds toward R&D
    Novo Nordisk announced further workforce reductions, bringing total departures to about 13,000 over the past year. CEO Maziar Mike Doustdar said the cuts are intended to free up capital for resear…
    BioSpace · 1mo agoLayoffsNegative↗ source
  • Boehringer Ingelheim to invest up to $1B in AI-driven solid tumor partnership with Envisagenics
    Boehringer Ingelheim announced a partnership with Envisagenics to develop precision oncology therapies that use artificial intelligence to identify cancer-specific RNA splicing alterations. The co…
    BioSpace · 1mo agoDealPositive↗ source