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  • 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
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  • 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
  • Murder suspect plans psychiatric defense in killing of UnitedHealthcare CEO
    Luigi Mangione has told the court he will rely on a psychiatric defense, arguing that he was suffering from extreme emotional disturbance when he shot UnitedHealthcare chief Brian Thompson. If a j…
    STAT · 2mo agoNegative↗ source
  • Neumora ends development of navacaprant after failed Phase 3 depression trials; EnGene cuts half its workforce
    Neumora Therapeutics announced it will discontinue its kappa opioid receptor antagonist navacaprant after the drug missed its primary endpoints in two Phase 3 studies for major depressive disorder.…
    BioPharma Dive · 2mo agoNegative readoutNegative↗ source
  • Eli Lilly to acquire non-opioid pain drug developer 4E Therapeutics, adding MNK inhibitor pipeline
    Eli Lilly announced it will purchase 4E Therapeutics, a biotech focused on non‑opioid pain treatments. The acquisition gives Lilly access to 4E’s experimental pipeline, including MNK inhibitors su…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • Edgewise Therapeutics' experimental heart drug meets Phase 2 endpoints in cardiomyopathy trial
    Edgewise Therapeutics reported that its oral candidate EDG-7500 achieved the predefined goals of a Phase 2 study in both obstructive and non‑obstructive hypertrophic cardiomyopathy. The trial demo…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Medicare to Cover Obesity Drugs for Adults 65+ Starting Next Month
    Medicare will begin covering prescription weight‑loss medications for beneficiaries aged 65 and older starting next month, marking the first time the program includes such drugs. The coverage is p…
    STAT · 2mo agoRegulatoryPositive↗ source
  • FDA gives modest backing to Moderna’s flu vaccine, noting efficacy questions but no major concerns
    The FDA released briefing documents ahead of an advisory committee meeting on Moderna’s seasonal influenza vaccine. The agency’s assessment was described as tepid, highlighting some questions abou…
    Endpoints · 2mo agoRegulatoryNeutral↗ source
  • FDA approves Colorado plan to import lower-cost drugs from Canada
    The U.S. Food and Drug Administration issued a letter confirming that Colorado may move forward with a pilot program to bring prescription medicines from Canada. The proposal aims to lower drug co…
    Endpoints · 2mo agoRegulatoryPositive↗ source