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1,422 stories matching this filter · ← front page

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  • Roche stops two Huntington's disease gene-silencing programs after disappointing trial data
    Roche announced it is ending development of two gene‑silencing candidates aimed at Huntington's disease after data failed to meet expectations. The decision follows a recent readout that showed in…
    STAT · 1mo agoNegative↗ source
  • ARPA-H awards $160 M to accelerate bespoke gene‑editing therapies for rare diseases
    ARPA-H announced a $160 million, five‑year investment through its THRIVE program to speed the development of personalized gene‑editing treatments for rare genetic conditions. The awardees include…
    BioPharma Dive · 1mo agoNeutral↗ source
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German Parliament votes to double mandatory drug rebate to 15.5%, sparking industry concerns
German lawmakers have approved a bill that would raise the mandatory rebate that drug manufacturers must give the government on branded medicines from the current 7% to 15.5%. The increase is inte…
STAT · 1mo agoRegulatoryNegative↗ source
  • FDA proposes streamlined registration rule for hub-and-spoke drug manufacturing networks
    The FDA released a proposed rule that would let distributed drug manufacturing facilities using a hub-and-spoke model register as a single establishment. Under current regulations each site must r…
    fda press · 1mo agoRegulatoryPositive↗ source
  • Nominee for HHS emergency response role has a history of questioning vaccines
    Sean Kaufman has been selected by the administration to lead the Office of Assistant Secretary for Preparedness and Response, overseeing the nation’s reaction to public health emergencies and disas…
    STAT · 1mo agoRegulatoryNegative↗ source
  • FDA delays deadline for electric shock device ban
    The Food and Drug Administration has quietly moved the enforcement date for the ban on certain electric shock devices to a later point in time. The agency did not issue a high‑profile announcement,…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • GSK, Hansoh ADC extends survival in lung cancer study
    GSK claimed the result was a first for an ADC aimed at the “B7-H3” protein, an increasingly popular target of late among cancer drugmakers.
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • Primary Care Shows Strong Performance Yet Remains Miscast as Health Crisis Solution
    The latest MedPAC report to Congress highlights that primary-care delivery in the United States is performing well by several measures. Nearly all Medicare beneficiaries have a designated primary-c…
    STAT · 1mo agoNeutral↗ source
  • Boston ER doctor Jeremy Faust grows influence with Inside Medicine newsletter
    Jeremy Faust works as an emergency physician at Brigham and Women's Hospital in Boston, handling busy shifts and caring for dozens of patients. In addition to his clinical duties, Faust runs the S…
    STAT · 1mo agoPositive↗ source
  • Boys' Club of New York offers after-school program that supports mental health of at-risk boys
    The Boys' Club of New York, a 150-year-old organization, runs three clubhouses serving about 2,500 middle-school boys from disadvantaged backgrounds. The program provides after-school and weekend…
    STAT · 1mo agoPositive↗ source
  • AstraZeneca and Ionis report failure of eplontersen in ATTR-CM trial
    AstraZeneca and Ionis said their nucleic‑acid drug eplontersen did not meet the primary goal in a large study of patients with transthyretin‑mediated amyloid cardiomyopathy (ATTR‑CM). Over a 140‑we…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • GSK ends $2.2 billion brain drug partnership with Alector after trial failures
    GSK and California‑based biotech Alector have ended their collaboration after both experimental brain drugs failed to meet development milestones. The partnership, announced in July 2021, gave GSK…
    BioPharma Dive · 1mo agoDealNegative↗ source
  • Michigan sees nearly 1,000 cyclospora cases, the state's largest outbreak and among the nation's biggest
    Nearly a thousand residents of Michigan have been diagnosed with a cyclospora infection that causes prolonged watery diarrhea, making it the biggest outbreak in the state's history and one of the l…
    STAT · 1mo agoNeutral↗ source
  • ARPA-H launches $160 million THRIVE program to fund seven labs developing custom gene-editing therapies for rare diseases
    ARPA-H, the U.S. Advanced Research Projects Agency for Health, announced a new initiative called THRIVE with up to $160 million in funding. The program will support seven research teams over five…
    STAT · 1mo agoPositive↗ 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
  • 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
  • HHS launches Operation Trialblazer to accelerate U.S. drug research amid growing competition from China
    The Department of Health and Human Services introduced a new initiative called Operation Trialblazer aimed at speeding early-stage drug research in the United States. The plan calls for coordinate…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ 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
  • Roche scraps two Ionis-partnered Huntington’s drugs
    The Swiss pharmaceutical giant told patient groups tominersen didn't delay disease progression in one trial, while a study of a second drug was scrapped because of a safety signal in animal testing.
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ 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
  • 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
  • Who’s going to run the FDA?
    RFK Jr.'s list of Covid vaccine injuries, a father's quest to cure his daughter, and more health news from Morning Rounds
    STAT · 1mo ago↗ source
  • STAT+: 931 days. The drug approval scandal hiding in plain sight
    Two years, six months, and 18 days have elapsed since Northwest Biotherapeutics submitted its brain cancer treatment for regulatory approval.
    STAT · 1mo ago↗ source
  • STAT+: AstraZeneca, Ionis report major trial failure with heart disease drug
    AstraZeneca and Ionis reported a notable trial failure Thursday in a heart disease that's become an increasingly competitive market for drugmakers.
    STAT · 1mo ago↗ source
  • Opinion: Your grandparents are using cannabis. Doctors can help them do it safely
    Over the past 25 years, I have treated thousands of medical cannabis patients with extremely few ill effects, one doctor writes.
    STAT · 1mo ago↗ source