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  • FDA reverses stance, allows UniQure to file for accelerated approval of Huntington’s gene therapy AMT-130
    The Food and Drug Administration has changed its earlier position and now permits UniQure to submit a marketing application for its experimental Huntington’s disease gene therapy, AMT-130. The age…
    STAT · 2mo agoRegulatoryPositive↗ source
  • Jazz Pharmaceuticals partners with AbCellera on T-cell engager program targeting GI cancers, deal up to $4.1 billion
    Jazz Pharmaceuticals announced a new collaboration with Canadian antibody company AbCellera to develop T-cell engager therapies aimed at gastrointestinal cancers. The agreement could be worth as m…
    Endpoints · 2mo agoDealPositive↗ source
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  • Spot Bio raises $40M to begin mRNA therapy trials for Duchenne muscular dystrophy
    Spot Bio, a biotech startup operating in California and China, has started preclinical testing of a genetic medicine aimed at restoring the missing protein dystrophin in patients with Duchenne musc…
    Endpoints · 2mo agoDealPositive↗ source
  • RFK Jr. announces $700 million mental-health funding, experts say money is from existing grants
    RFK Jr. announced a $700 million package aimed at mental health and addiction services, with a particular focus on addressing homelessness linked to severe, untreated mental illness. Behavioral he…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • DOJ settlement forces OhioHealth to change contracting, prompting hospitals to review payer agreements
    The Department of Justice and the Ohio attorney general announced a proposed antitrust settlement that requires nonprofit OhioHealth to stop using certain contracting practices that were said to ke…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • FDA signals new window for companies with recent complete response letters after commissioner’s exit
    After FDA Commissioner Marty Makary left, the agency indicated it will reconsider drugs that received complete response letters in the past year. The move offers sponsors a chance to resubmit thei…
    Endpoints · 2mo agoRegulatoryPositive↗ source
  • FDA issues warning letters to 25 telehealth firms over misleading compounded GLP-1 marketing
    The U.S. Food and Drug Administration has sent warning letters to 25 telehealth companies. The letters cite concerns about how the firms promote compounded GLP-1 drugs used for weight loss. The ag…
    Endpoints · 2mo agoRegulatoryNegative↗ source
  • UniQure plans to file Huntington’s disease gene therapy with FDA after leadership shift eases data requirements
    UniQure, a Dutch biotech, announced it will seek FDA approval for its gene therapy targeting Huntington’s disease later this summer. The company said FDA staff indicated that three years of data f…
    BioPharma Dive · 2mo agoRegulatoryNeutral↗ source
  • Hackers claim to have stolen Novo Nordisk AI models and drug manufacturing recipes, demand $25M ransom
    Novo Nordisk disclosed that a hacker group says it has obtained the company's proprietary AI models and manufacturing recipes for its drugs. The group alleges the data is for sale and has demanded…
    Endpoints · 2mo agoNegative↗ source
  • FDA reverses earlier stance, grants uniQure accelerated approval pathway for Huntington's gene therapy
    On June 17, 2026, the U.S. Food and Drug Administration issued a second reversal, allowing biotech company uniQure to pursue an accelerated approval pathway for its gene therapy targeting Huntingto…
    Endpoints · 2mo agoRegulatoryPositive↗ source
  • Jazz partners with AbCellera on $4 billion deal to develop next-generation T-cell engagers for solid tumors
    Jazz Pharmaceuticals disclosed a collaboration with AbCellera aimed at creating next-generation T-cell-engaging antibodies for solid tumors. Under the agreement Jazz will pay $56 million up front…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • FDA signals openness to Moderna flu vaccine and clears UniQure's Huntington's therapy as Eli Lilly acquires 4E Therapeutics
    The U.S. Food and Drug Administration indicated it is receptive to Moderna's seasonal flu vaccine ahead of the upcoming advisory committee meeting, suggesting a smoother review path. UniQure repor…
    STAT · 2mo agoRegulatoryPositive↗ source
  • Cyber extortion group claims to have stolen over a terabyte of Novo Nordisk data after failed $25 million ransom demand
    A cyber‑extortion group called FulcrumSec said it obtained more than one terabyte of data from Novo Nordisk. The group said it tried to extract a $25 million ransom, but Novo Nordisk did not pay,…
    STAT · 2mo agoNegative↗ source
  • Westlake-backed Vedana Therapeutics raises $46M to develop anti-PACAP migraine prevention drugs
    Vedana Therapeutics, a new biotech formed out of stealth, announced it has secured $46 million in financing backed by Westlake. The capital will be used to advance its anti-PACAP antibody program a…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • Physician warns of surge in congenital syphilis cases, highest in decades
    The CDC reported nearly 4,000 cases of congenital syphilis in 2024, the most since the mid-1950s. About 5-10% of those infants are stillborn or die shortly after birth, and many survivors face life…
    STAT · 2mo agoNegative↗ source
  • VC Julie Grant argues U.S. should not restrict biotech investments in China
    Julie Grant, a venture capitalist, told STAT+ that she opposes any U.S. effort to limit biotech investments in China. She says the biotech sector has become increasingly interdependent over decade…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • Triveni Bio secures $65M Series C as second eczema candidate enters clinical trials
    Triveni Bio announced a $65 million Series C financing round aimed at supporting its ongoing development programs. The round was co‑led by Ascenta Capital and Janus Henderson Investors, with parti…
    Endpoints · 2mo agoDealPositive↗ source
  • Migraine biotech Vedana Therapeutics raises $46 million Series A to advance preclinical pipeline
    Vedana Therapeutics, a new biotech focused on migraine, has announced its emergence from stealth mode after securing a Series A financing round. The company raised $46 million from investors, whic…
    Endpoints · 2mo agoDealPositive↗ source
  • FTC and Four State Attorneys General Sue Transgender Health Group Over Alleged Misleading Claims
    The Federal Trade Commission, together with attorneys general from Alaska, Iowa, Nebraska and Texas, filed a lawsuit on Wednesday in a Texas federal court against the World Professional Association…
    STAT · 2mo agoRegulatoryNegative↗ source
  • NIH Diversity Programs Found to Double Undergraduate PhD Odds in 20-Year Study
    A 20‑year study published in Science Advances reports that two NIH‑funded diversity initiatives, the Research Initiative for Scientific Enhancement (RISE) and Minority Access to Research Careers (M…
    STAT · 2mo agoNeutral↗ source
  • Trump administration moves special-education oversight to Health and Human Services
    The Trump administration announced that responsibility for special education will be transferred from the Department of Education to the Department of Health and Human Services. This change is part…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • Advocacy groups urge FDA to revoke approval of antibiotics used for disease prevention in livestock
    More than 60 organizations have filed a petition with the FDA asking the agency to withdraw its approval for the use of antibiotics in food‑producing animals for disease prevention and growth promo…
    STAT · 2mo agoRegulatoryNegative↗ source
  • Abridge’s Patient-Centered Claim Scrutinized in STAT AI Prognosis
    Brittany Trang, a health‑tech reporter, wrote a piece for STAT’s AI Prognosis newsletter that takes a close look at Abridge’s assertion that its ambient scribe platform is "patient‑centered." The…
    STAT · 2mo agoNegative↗ source
  • Oncologists Find Deep Joy in Delivering Hope to Patients and Families
    Khushali Jhaveri, a lymphoma specialist at Indiana University, shares a personal view of what makes oncology rewarding. She recounts a recent encounter with a patient who had endured multiple trans…
    STAT · 2mo agoPositive↗ source
  • STAT decides to keep “health care” as two words despite AP style change
    STAT’s editorial team faced a dilemma after the Associated Press Stylebook announced that “healthcare” will now be written as a single word. The change, revealed at the AP Editors Conference, spark…
    STAT · 2mo agoNeutral↗ source