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  • Kyverna reports year-long efficacy and clean safety for miv-cel CAR-T in autoimmune trials
    Kyverna Therapeutics released one-year data for its CAR-T candidate miv-cel in stiff person syndrome and 18-month data in generalized myasthenia gravis. The single dose showed durable clinical ben…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Former Changsheng biotech chair sentenced to life in prison over Chinese rabies vaccine scandal
    Chinese authorities sentenced Gao Junfang, the former chairwoman of Changsheng Biotechnology, to life imprisonment after a court found her guilty of wrongdoing in a rabies vaccine scandal. The cas…
    Endpoints · 1mo agoRegulatoryNegative↗ source
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  • Enveda secures $311 million in third consecutive megaround to advance discovery and weight-maintenance programs
    Enveda, a biotech startup operating out of Colorado and India, announced a new financing round on September 23, 2026. The company raised $311 million, marking its third large-scale funding round i…
    Endpoints · 1mo agoDealPositive↗ source
  • Flagship Pioneering secures Pentagon contract to develop biological threat countermeasures
    Flagship Pioneering, a biotech investment firm, has been awarded a contract by the U.S. Department of Defense. The contract aims to advance technologies that can serve as countermeasures against b…
    STAT · 1mo agoDealPositive↗ source
  • AI startup Basecamp Research secures $140 million Series C funding and outlines six-program AI pipeline
    Basecamp Research, an AI-driven biotech founded in 2019, announced a $140 million Series C financing round. The company said the new capital will support its ambitious six-program pipeline that ap…
    Endpoints · 1mo agoDealPositive↗ source
  • US HHS and FDA announce new rules to expand non-animal testing methods as legal battles over youth gender-affirming care continue
    The legal landscape for youth gender‑affirming care remains turbulent, with the Trump administration's aggressive stance prompting dozens of hospitals nationwide to halt such services, even in the…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Roche reports positive interim Phase 3 results for kidney drug, paving way for accelerated approval
    Roche announced interim results from its Phase 3 trial of a kidney disease therapy, indicating the study met its primary endpoints. The data, released on Wednesday, suggest the drug could qualify…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Novo outlines $23B revenue goal, cuts 4,000 jobs and expands Wegovy manufacturing amid investor skepticism
    Novo held its Capital Markets Day to detail a plan to reach $23 billion in sales by 2035. The company announced another round of layoffs, trimming its workforce by 4,000 people and leaving the head…
    BioSpace · 1mo agoNeutral↗ source
  • Boehringer Ingelheim boosts Variant Bio partnership with $250 million for cardiovascular research
    Boehringer Ingelheim announced an expansion of its collaboration with Variant Bio. The partnership will now include cardiovascular disease research, broadening its original scope. The deal value…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • FDA shift sparks renewed pharma and VC focus on osteoporosis drug development
    The FDA recently altered its regulatory framework for osteoporosis medicines, prompting a wave of renewed interest across the pharmaceutical sector. Earlier, drugs from Eli Lilly, Merck, Novartis…
    STAT · 1mo agoRegulatoryPositive↗ source
  • Insurers UnitedHealth, CVS, and Kaiser oppose Medicare's contractor ban on remote patient monitoring
    Major insurers including UnitedHealth Group, CVS Health and Kaiser Permanente have formally objected to a new Medicare proposal that would change billing for remote patient monitoring (RPM). The p…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • White House plan to tighten control over NIH grants stalls after bipartisan opposition
    A proposed executive order that would have given the White House significant authority over National Institutes of Health grant awards is now considered dead. The plan called for a commission of p…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Human‑centric testing methods promise safer, cheaper drug development but repeatability remains a key obstacle
    Regulators such as the FDA, EMA and ICH are urging drug developers to replace animal safety studies with New Approach Methodologies that use human‑relevant models. Early research shows these models…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Roivant's FcRn drug IMVT-1402 fails Phase 2b lupus trial
    Roivant announced that its FcRn-targeting antibody IMVT-1402 (imeroprubart) failed to meet primary endpoints in a Phase 2b trial in patients with lupus. The study did not show improvement in disea…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • Job postings in Pennsylvania’s biopharma sector surge 213% as nine companies ramp up hiring
    Job postings for biopharma roles in Pennsylvania have jumped dramatically, with BioSpace reporting a 213% year‑over‑year increase in August and overall postings tripling compared with the previous…
    BioSpace · 1mo agoPositive↗ source
  • Pharma companies compete for scarce manufacturing talent as reshoring ramps up
    As pharmaceutical firms expand or add U.S. manufacturing sites to bring production back home, they are finding it hard to staff the plants. The industry faces a limited pool of qualified workers,…
    BioSpace · 1mo agoNeutral↗ source
  • 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
  • Immunovant halts cutaneous lupus program after phase 2 failure
    Immunovant announced it is discontinuing development of its anti-FcRn antibody IMVT-1402 for cutaneous lupus erythematosus. The decision follows a mid-phase trial that did not meet its primary end…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Industry groups back FDA’s proposed distributed manufacturing rule, seek clarification on implementation
    Industry trade groups have expressed overall support for the FDA’s draft rule that would allow drugs to be produced using distributed manufacturing models. The proposal aims to modernize the supply…
    raps · 1mo agoRegulatoryNeutral↗ source
  • 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