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  • SK Biopharma signs $315 million deal with 1ST Biotherapeutics for preclinical Parkinson’s drug 1ST-104
    SK Biopharmaceuticals has entered a licensing agreement with South Korean biotech 1ST Biotherapeutics that could be worth up to $314.8 million. The deal includes an upfront payment of $1.8 million,…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Longeveron’s pediatric heart stem-cell trial misses primary endpoint, prompting cost cuts
    Longeveron reported that its phase 2b Elpis II trial of the stem-cell product laromestrocel in infants with hypoplastic left heart syndrome failed to meet its primary efficacy endpoint. The study…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
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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
  • Kennedy appoints eight specialists to U.S. Preventive Services Task Force, ending year-long vacancy
    Health secretary Robert F. Kennedy Jr. appointed eight new members to the U.S. Preventive Services Task Force, filling vacancies after the panel had not met for more than a year. The appointees in…
    STAT · 1mo agoNeutral↗ 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
  • Startup launches trial of psychedelic-style drug for Parkinson’s symptom
    A new biotech startup announced it will begin preclinical testing of a psychedelic-like compound aimed at alleviating a specific symptom of Parkinson’s disease. The company plans to evaluate the d…
    STAT · 1mo agoNeutral↗ source
  • Shift away from oppositional defiant disorder reflects changing views on child noncompliance
    Lawrence Diller, a behavioral pediatrician, writes about a noticeable shift in how clinicians label children who resist authority. He recounts a recent call from a mother who asked whether her son…
    STAT · 1mo agoNeutral↗ source
  • Definium shares new psychedelics data and court reprieve for international researchers discussed on The Readout LOUD
    The latest episode of STAT's "The Readout LOUD" podcast covered two timely topics: Definium's recently released psychedelics data and a court decision that gave international scientists a brief leg…
    STAT · 1mo agoNeutral↗ source
  • FDA hiring delays persist despite expectations, and Bavarian Nordic names new CEO
    The recent discussion about a hiring surge at the U.S. Food and Drug Administration following last year’s DOGE budget cuts has not materialized as expected. Industry observers had anticipated a rap…
    STAT · 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
  • Health Secretary RFK Jr. delivers anti‑vaccine keynote at Children’s Health Defense conference
    Robert F. Kennedy Jr., the U.S. health secretary, opened the Children’s Health Defense conference with a keynote that focused on his criticism of vaccines. The speech revisited his broader health…
    STAT · 1mo agoNegative↗ 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
  • Chutes & Ladders—Legend poaches Novartis vet to boost commercial potential
    After former Legend Biotech CEO Ying Huang, Ph.D., left the company suddenly in July, Legend has found its permanent CEO, poaching Novartis veteran Ingrid Zhang as the CAR-T specialist eyes its nex…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Zocdoc adds chatbot scheduling and updates on Medicare ACCESS
    Zocdoc announced that its platform now lets users book medical appointments directly through chatbots and health‑plan websites. The new integration means patients can schedule visits without leavi…
    STAT · 1mo agoNeutral↗ source
  • Health secretary Kennedy launches program to accelerate autism diagnosis
    U.S. health secretary Robert F. Kennedy Jr. announced a new initiative aimed at speeding up autism assessments during a keynote at a Children’s Health Defense conference. He said the existing diag…
    STAT · 1mo agoPositive↗ source
  • STAT+: FDA approves a new gene therapy for Sanfilippo syndrome, an ultra-rare disease
    The FDA approved a new gene therapy for Sanfilippo syndrome type A, an ultra-rare disease sometimes known as childhood Alzheimer’s.
    STAT · 1mo ago↗ 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
  • Novo signs $1.4 billion deal with Orbis Medicines to develop oral macrocycle cardiometabolic drugs
    Novo, which recently rebranded from Novo Nordisk, announced a partnership with Copenhagen‑based Orbis Medicines. The agreement could provide up to $1.4 billion in upfront payments and milestone pay…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Novartis halts ALS drug VHB937 after phase 2 trial fails to meet endpoints
    Novartis announced it is stopping development of its ALS candidate VHB937 after the phase 2 Astrals trial did not meet its primary or secondary endpoints. The study enrolled 251 patients with earl…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ 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
  • Stanford researchers create mice with half human brain tissue using cerebral organoids
    Scientists at Stanford have implanted human cerebral organoids into mice whose own brain regions were genetically removed, producing neuro-chimeric animals whose brains are about half human by volu…
    STAT · 1mo agoNeutral↗ source