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  • CMS launches 10-year ACCESS health-tech pilot for Medicare
    CMS recently held an event to commemorate the summer launch of the ACCESS model, a decade-long pilot aimed at integrating health-technology solutions into Medicare. The program will test new digit…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Endpoints 11 reveals 2026’s most promising biotech startups at Boston gala
    The Endpoints editorial team announced the Endpoints 11 list, highlighting the most exciting biotech startups of 2026. The selection process involved months of research, interviews with executives,…
    Endpoints · 1mo agoNeutral↗ source
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  • MHRA AI Commission Issues 44 Recommendations for Future UK Regulatory Framework
    A commission established by the Medicines and Healthcare products Regulatory Agency has released its findings. The group presented 44 recommendations aimed at shaping the United Kingdom’s regulato…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Former FDA chief Califf calls for regulatory overhaul and predicts AI assistants in future oversight
    Robert Califf, who served as FDA commissioner, reflected on his early experience as a medical student in the 1970s working with a pioneering patient database that tracked cardiovascular procedures…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Bavarian Nordic appoints former Sanofi, AstraZeneca and Pfizer executive Tarja Stenvall as CEO
    Bavarian Nordic announced that Tarja Stenvall will become its president and chief executive, succeeding Paul Chaplin. Stenvall brings decades of experience from senior roles at Sanofi, AstraZeneca…
    Endpoints · 1mo agoNeutral↗ source
  • FDA officials stress administration priorities in draft PDUFA VIII commitment letter
    At a public meeting on Wednesday, FDA officials presented the proposed commitment letter for the upcoming PDUFA VIII program. The letter reiterates the administration's priorities, reflecting the…
    raps · 1mo agoRegulatoryNeutral↗ source
  • General Catalyst outlines tech collaborations with Summa Health after hospital acquisition
    General Catalyst, a venture capital firm, is now describing how it plans to integrate technology with Summa Health following its purchase of the hospital network. The firm says the focus will be o…
    Endpoints · 1mo agoNeutral↗ source
  • FDA approves Ultragenyx's gene therapy for Sanfilippo syndrome type A
    The FDA granted full approval to a rare disease gene therapy from Ultragenyx on Thursday, giving the company a much-needed boost in an otherwise difficult year. The therapy, called UX111, will be b…
    Endpoints · 1mo ago↗ source
  • Two more biotechs, Marea and North Immunology, do reverse mergers
    The reverse merger party is still buzzing. This time, it's a cardio and endocrine startup with two drugs in Phase 2 and a biotech working on a long-acting immunology and inflammation (I&I) drug. Mi…
    Endpoints · 1mo ago↗ source
  • Roche turns to Dualitas to find new bispecific approaches for immunology
    Roche is turning up the heat on its hunt for next-generation bispecific antibodies in a deal that will involve screening 300,000 new combinations for inflammatory and immunology conditions. The Swi…
    Endpoints · 1mo ago↗ source
  • Five major drugmakers cooperate with House investigation of Chinese military hospital trials
    Rep. John Moolenaar, a Republican from Michigan, announced that five large pharmaceutical companies are working with a congressional probe into clinical trials conducted at Chinese military hospita…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Gilead signs HIV PrEP partnership with PAHO in Latin America
    Gilead Sciences announced a new agreement with the Pan American Health Organization to expand access to HIV pre‑exposure prophylaxis across Latin American markets. The partnership aims to leverage…
    Endpoints · 1mo agoDealPositive↗ source
  • Stanford researchers create mice with human neurons to advance disease studies
    Researchers at Stanford University have engineered mice whose cerebral cortex is largely filled with human neurons, replacing missing cells in the animal brain. The chimeric mice are presented as…
    Endpoints · 1mo agoPositive↗ source
  • Novo and Anthropic partner to test Claude Science AI platform in drug discovery R&D
    Novo, the Danish pharmaceutical company, announced a partnership with AI firm Anthropic. The collaboration will focus on evaluating Anthropic’s Claude Science AI model within Novo’s research and d…
    Endpoints · 1mo agoDealPositive↗ source
  • Novartis scraps TREM2 ALS candidate after Phase 2 failure
    Novartis announced it is halting development of its TREM2-targeting drug VHB937, also known as lifonebart, after the Phase 2 trial in amyotrophic lateral sclerosis (ALS) did not meet its primary en…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • Sling Therapeutics raises $123M to fund Phase 3 trial of former Astellas cancer drug for thyroid eye disease
    Investors have committed $123 million to Sling Therapeutics, a small Michigan biotech focused on eye‑disease treatments. The funding will support a Phase 3 clinical trial of a drug originally deve…
    Endpoints · 1mo agoDealPositive↗ source
  • Skyhawk Therapeutics reports symptom improvement for Huntington's disease in Phase 1/2 extension study
    Skyhawk Therapeutics announced that its RNA-splicing candidate SKY-0515 showed a measurable improvement in symptoms for patients with Huntington's disease during an extension of its Phase 1/2 trial…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Experts urge more representative enrollment in clinical trials
    A panel of regulators and industry leaders gathered to discuss how clinical trials can better reflect the diversity of patient populations. The discussion included officials from the U.S. Food and…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Yale and Harvard faculty question benefits of FDA's 'America First' user fee provisions
    Yale and Harvard medical school faculty have voiced concerns about the latest FDA user fee agreement, which includes a set of "America First" provisions. The provisions are designed to prioritize…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Experts assess EU medical device and diagnostic regulations at RAPS Convergence 2026
    A panel of experts representing the European Commission, industry groups and notified bodies gathered in Charlotte, North Carolina during RAPS Convergence 2026. The group reviewed the current stat…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Vera Therapeutics reports two-year data showing Trutakna stabilizes kidney function in IgA nephropathy, paving way for full FDA approval
    Vera Therapeutics announced that its recently approved drug Trutakna has produced encouraging two-year results in patients with IgA nephropathy, a chronic autoimmune kidney disease. The data indic…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • RegCell secures multi-million dollar Series A to advance Nobel-winning regulatory T-cell therapy
    RegCell, a biotech founded by Nobel laureate Shimon Sakaguchi, announced a new financing round to move its regulatory T-cell (Treg) program toward clinical testing. The company’s CEO Michael McCul…
    Endpoints · 1mo agoDealPositive↗ source
  • FDA launches expedited IND pilot program, integrating public feedback into qualification criteria
    The FDA announced that its long-awaited expedited investigational new drug (IND) pilot program has started accepting applications as of Tuesday. Agency leaders Karim Mikhail and Michael Davis, new…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Axoltis reports Phase 2 failure of experimental ALS drug but notes small signal
    Axoltis Pharma, a French biotech, announced that its Phase 2 trial of an experimental ALS therapy did not meet its primary endpoints. The company said the data were noisy but observed a modest tre…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • FDA Opens Expedited IND Pilot to Speed First-in-Human Trials, Applications Accepted Through Oct. 30
    The U.S. Food and Drug Administration announced the final design of an Expedited IND Pilot aimed at shortening the time from drug discovery to first-in-human trials. The pilot pairs drug developer…
    fda press · 1mo agoRegulatoryNeutral↗ source