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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 · 4mo agoRegulatoryNeutral↗ 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 · 4mo agoDealPositive↗ source
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  • 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo agoRegulatoryNeutral↗ source
  • FDA approves first generic single-dose baloxavir tablet for flu treatment and prevention
    FDA announced approval of the first generic version of Xofluza (baloxavir marboxil) tablets, a single-dose treatment for acute uncomplicated influenza and prophylaxis for patients five years of age…
    fda press · 4mo agoApprovalPositive↗ 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo agoRegulatoryPositive↗ source
  • FDA approves OTC naloxone nasal spray Rextovy, expanding consumer access to overdose treatment
    The FDA announced approval of a new over-the-counter naloxone nasal spray called Rextovy, delivering 4 mg of naloxone hydrochloride for emergency reversal of opioid overdose. The product can be pu…
    fda press · 4mo agoApprovalPositive↗ source
  • Biotech Converts Failed Trial Data into AI Model
    A biotech startup recently faced a setback when a clinical trial did not achieve its primary goals. Rather than discarding the results, the company chose to analyze the data for new insights. The…
    STAT · 4mo agoPositive↗ source
  • Express Scripts and PCMA file lawsuits to block Tennessee FAIR Rx Act targeting PBM-owned pharmacies
    Express Scripts, a Cigna subsidiary, and the Pharmaceutical Care Management Association have filed separate lawsuits in federal court in Tennessee. The suits challenge the FAIR Rx Act, a law passe…
    BioPharma Dive · 4mo agoRegulatoryNeutral↗ source
  • FDA staff raise concerns over data for Moderna’s mFlusiva flu vaccine ahead of advisory panel
    FDA staff have examined the evidence for Moderna's mFlusiva, an mRNA flu vaccine, and highlighted shortcomings in the data submitted to the agency. The Food and Drug Administration will convene an…
    BioPharma Dive · 4mo agoRegulatoryNegative↗ source
  • Verge Labs launches AI tool to boost patient enrollment and trial efficiency; Moderna appoints new chief commercial officer
    Verge Labs announced a new artificial‑intelligence model designed to identify patients most likely to respond to a therapy, aiming to reduce dropout rates and increase the statistical power of clin…
    STAT · 4mo agoPositive↗ source