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  • Ipsen's Dysport shows positive Phase 3 results in migraine, Tarsus acquires iRenix for $75M
    Ipsen reported that its injectable neurotoxin Dysport met the primary endpoint in a Phase 3 trial aimed at reducing monthly migraine days. The trial demonstrated a statistically significant reduct…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Prime Secures Arbitration Victory Over Beam, Paving Way for Clinical Trials
    Prime, a biotech firm developing a gene‑therapy candidate, won an arbitration case against Beam Therapeutics. The ruling removes a legal hurdle and allows Prime to advance its program into clinical…
    STAT · 1mo agoRegulatoryPositive↗ source
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  • AstraZeneca/Ionis heart-failure drug Wainua fails pivotal trial as White House reviews FDA commissioner candidates
    The White House is reviewing a shortlist of three candidates for the FDA commissioner position, according to STAT. The list includes White House adviser Heidi Overton, oncologist and health‑system…
    STAT · 1mo agoNegative readoutNegative↗ source
  • Father invests $70 million in gene therapy quest for daughter with ultra‑rare NGLY1 deficiency, faces FDA scrutiny
    Matt Wilsey has spent a decade and roughly $70 million trying to develop a gene therapy for his daughter Grace, who suffers from NGLY1 deficiency, an ultra‑rare genetic disorder. NGLY1 deficiency…
    STAT · 1mo agoRegulatoryPositive↗ source
  • GSK terminates $700 million Alector partnership after recent trial setbacks
    GSK has decided to end its collaboration with Alector, a biotech focused on neurodegenerative diseases. The agreement originally included a $700 million upfront payment. The move follows two high-…
    Endpoints · 1mo agoDealNegative↗ source
  • Northwest Biotherapeutics' brain cancer therapy faces 931-day delay in UK approval
    Northwest Biotherapeutics, a public biotech developing a brain cancer treatment, filed a marketing application with the UK Medicines and Healthcare products Regulatory Agency (MHRA) in late Decembe…
    STAT · 1mo agoRegulatoryNegative↗ source
  • New OpenEvidence study shows it outperforms general-purpose LLMs in health-tech research
    A recent study funded by OpenEvidence compared its platform to general-purpose large language models (LLMs) in health technology research and concluded that OpenEvidence delivered more accurate and…
    STAT · 1mo agoPositive↗ source
  • White House reviews three candidates to lead the FDA
    STAT+ reports that the White House is currently evaluating three leading candidates to become the next head of the Food and Drug Administration. The review process is part of the administration's e…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Mid-year roundup highlights top health-tech trends in 2026
    The editorial team notes that the first half of 2026 has been unusually active for health technology. Five major developments have been identified as the most significant so far. One clear theme i…
    Endpoints · 1mo agoNeutral↗ source
  • Catalent to sell its Nottingham oral solid dose facility to CDMO Codis
    Catalent announced it will divest its United Kingdom manufacturing site, selling the oral solid dose factory located in Nottingham. The buyer is Codis, a contract development and manufacturing org…
    Endpoints · 1mo agoDealNeutral↗ source
  • Doctors urge safe medical cannabis use as more seniors turn to marijuana
    Older adults are becoming the fastest‑growing segment of medical cannabis patients, according to the author, an addiction specialist at Massachusetts General Hospital. He recounts a recent inciden…
    STAT · 1mo agoNeutral↗ source
  • Experts question commercial motives behind labeling obesity as a disease
    Max Moser, a psychology researcher at University College London, argues that calling obesity a disease gives comfort to some patients but also creates a commercial dynamic for drugmakers. Companie…
    STAT · 1mo agoNegative↗ source
  • Podcast discusses health insurance costs, whistleblower case, and potential FDA commissioner picks
    The Readout LOUD podcast episode explores why employer-provided family health insurance can be as expensive as a new car. The hosts interview a whistleblower who challenged an insurance contractor…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Health officials discuss screen-time harms at Great American State Fair's MAHA Monday
    The Great American State Fair in Washington concluded its two‑week run with a second “MAHA Monday,” a program highlighting the Make America Healthy Again initiative. STAT reporters Alex Hogan and…
    STAT · 1mo agoNeutral↗ source
  • Prime Medicine clears legal hurdle with Beam Therapeutics, moves AATD gene therapy toward clinic
    Prime Medicine announced it will advance its AATD gene editing candidate into clinical trials after arbitrators ruled in its favor in a dispute with Beam Therapeutics. The dispute centered on a 20…
    Endpoints · 1mo agoPositive↗ source
  • White House conducts final review of three candidates for FDA commissioner
    The White House is completing its final review of candidates to become the next Food and Drug Administration commissioner. The shortlist features Heidi Overton, a current White House adviser; Jeff…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • U.S. officials urge pharma companies to increase domestic production of essential generic drugs
    At a private gathering in the Eisenhower Executive Office Building, senior officials from the Trump administration met with pharmaceutical leaders. Secretary of State Marco Rubio, Health Secretary…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Lung transplants boost survival for select stage 4 lung cancer patients, study finds
    Northwestern Medicine surgeons and oncologists performed double lung transplants on a small group of stage 4 lung cancer patients whose disease was confined to the lungs. The JAMA study compared 1…
    STAT · 1mo agoPositive readoutPositive↗ source
  • Novartis announces reduction of 322 jobs at New Jersey facility
    Novartis filed a WARN notice indicating it will eliminate 322 positions at its East Hanover, New Jersey site. The reduction is part of a broader restructuring effort aimed at streamlining operation…
    Endpoints · 1mo agoLayoffsNegative↗ source
  • Europe to Speed Review of RevMed Drug as Concerns Rise Over Kailera GLP-1 Pill and FDA Clears Vera Therapy
    European regulators said they will move more quickly to assess RevMed's investigational drug, aiming to shorten the evaluation timeline. Separate reports highlighted that recent data from Kailera'…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Prime Medicine wins arbitration over gene-editing dispute with Beam, clearing path for AATD trial
    Prime Medicine announced it had prevailed in an arbitration against Beam Therapeutics, ending a dispute over gene-editing technology. The arbitrator determined that Prime’s work on a gene-editing…
    STAT · 1mo agoRegulatoryPositive↗ source
  • FDA approves Vera Therapeutics' Trutakna for IgA nephropathy, pricing set at $425,000 per year
    The U.S. Food and Drug Administration has granted approval to Trutakna, a new therapy from Vera Therapeutics, for the treatment of IgA nephropathy. IgA nephropathy is a kidney disorder where immun…
    STAT · 1mo agoApprovalPositive↗ source
  • HHS pushes FDA to formalize public release of rejection letters to drug makers
    HHS announced it is preparing a new FDA regulation that would codify the agency's practice of publishing complete response letters (CRLs) that inform pharmaceutical companies of a drug's rejection.…
    Endpoints · 1mo agoCRLNeutral↗ source
  • ACA insurers seek median 14% premium hike for 2027 as enrollment falls
    Insurers filing with state regulators for 2027 ACA plans are asking for a median premium increase of 14%, according to an analysis of filings in 16 states and the District of Columbia. This would…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Biohaven targets muscle-sparing obesity market to compete with Lilly's GLP-1 drugs
    Biohaven is positioning itself to address obesity by developing treatments that preserve lean muscle, a differentiator from existing GLP-1 therapies. The company sees an opportunity to act as a "s…
    Endpoints · 1mo agoNeutral↗ source