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  • FDA places partial hold on Biohaven epilepsy drug BHV-7000 amid $350 million licensing deal
    The U.S. Food and Drug Administration issued a partial clinical hold on enrollment for Biohaven’s epilepsy candidate BHV-7000 after rodent studies raised questions about drug metabolites. The hold…
    Fierce Biotech · 4d agoRegulatoryNegative↗ source
  • Takeda R&D chief Andy Plump to retire after string of recent FDA approvals
    Takeda's long-serving research and development president Andy Plump will step down in June. He joined the Japanese drugmaker in 2015 from Sanofi and has led the R&D organization since then. His ex…
    Fierce Biotech · 4d agoPositive↗ source
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Infectious Disease459
  • Midterm races in Iowa, Florida and others could shape US vaccine policy
    Vaccine policy has emerged as a prominent issue in the lead‑up to the November midterms, spurred by the president and health secretary’s skeptical stance. In Iowa, the Republican candidate for gov…
    STAT · 4d agoNeutral↗ source
  • Pharma investment in UK rises as government increases drug pricing and engagement
    The UK trade group says pharmaceutical investment is picking up after a lull last year. The uptick follows recent government steps to raise reimbursement rates for medicines and to foster closer c…
    Endpoints · 4d agoRegulatoryPositive↗ source
  • UK issues AI-in-medicine regulatory recommendations; FDA pauses new enrollment in Biohaven epilepsy trials
    The United Kingdom has released a set of recommendations aimed at governing the use of artificial intelligence in medical applications. The guidance outlines how AI tools should be evaluated and mo…
    raps · 4d agoRegulatoryNeutral↗ source
  • Trump administration to mail $500 checks to about 1 million non‑subsidized ACA enrollees before midterms
    The White House announced a program to send $500 refund checks to roughly one million people who have Affordable Care Act health plans but do not receive federal subsidies. The payments are schedul…
    STAT · 3d agoNegative↗ source
  • Study finds doctors still accept pharma gifts and speaking fees despite ongoing debate
    A new analysis surveyed 283 physicians who had previously responded as part of a 2011 study of more than 1,300 medical students and residents. The researchers compared the recent responses with the…
    STAT · 3d agoNegative↗ source
  • Lonza announces new spray-drying plant in Bend, Oregon as Samsung Bio secures $262 million contract
    Lonza announced plans to construct a new commercial spray-drying facility in Bend, Oregon, expanding its manufacturing footprint in the United States. The plant will increase Lonza’s capacity to p…
    Endpoints · 3d agoPositive↗ source
  • UniQure to release four-year Huntington’s gene therapy results by September
    UniQure, a biotech firm, will report four-year data from its Huntington’s disease gene therapy trial before the end of September. The therapy, AMT-130, has already been submitted to regulators in…
    STAT · 3d agoPositive readoutNeutral↗ source
  • FDA signals openness to innovative approaches for psychedelic drug development
    FDA officials said the agency is open to novel, innovative approaches to the clinical development of psychedelic drugs, citing the worsening mental health crisis in the United States. The agency’s…
    raps · 4d agoRegulatoryNeutral↗ source
  • Scientists boycott American Diabetes Association after conference expulsions
    Following the removal of five scientists from its annual conference in June, members of the American Diabetes Association (ADA) have initiated a boycott of the organization. The protest stems from…
    Fierce Biotech · 3d agoNegative↗ source
  • Biotech industry rebounds as Endpoints 11 awards return in Boston
    The article notes that the Endpoints 11 awards will be unveiled in Boston on the night of September 24, marking the event’s return after a period of industry slowdown. It reflects on how the biote…
    Endpoints · 3d agoNeutral↗ source
  • EMA revises GVP inspection guideline to incorporate new subcontractor rules
    The European Medicines Agency has issued an update to its guideline on good pharmacovigilance practice inspections. The revision aligns the guidance with recent changes to the rules governing subco…
    raps · 4d agoRegulatoryNeutral↗ source
  • Trump officials turn to AI to address rural health care challenges as nominees await Senate confirmation
    The article notes that nominees for top federal health positions will soon be questioned by Congress, highlighting upcoming scrutiny of health leadership. It also reports that officials in the Tru…
    STAT · 3d agoNeutral↗ source
  • Takeda R&D chief Andy Plump to leave after 12 years
    Takeda announced that its President of Research and Development, Andy Plump, M.D., Ph.D., will depart the company in June after serving in the role for twelve years. He will remain in charge of R&D…
    Fierce Biotech · 3d agoNeutral↗ source
  • CMS chief Mehmet Oz touts AI avatars for rural health, but some hospital leaders remain skeptical
    Centers for Medicare and Medicaid Services (CMS) head Mehmet Oz announced that artificial-intelligence based avatars could help deliver medical care to patients in rural communities. The proposal…
    STAT · 3d agoNeutral↗ source
  • Evergreen Fresh Sprouts recalls 215 cases of broccoli sprouts over possible Salmonella contamination
    Evergreen Fresh Sprouts LLC of Moyie Springs, Idaho announced a recall of 215 cases of its broccoli sprouts due to potential Salmonella contamination. The product, packaged in 4‑oz zip‑lock bags,…
    fda recalls · 3d agoRegulatoryNegative↗ source
  • Oura files S-1, outlining its plans to expand into healthcare as it prepares for IPO
    Oura, known for its sleep-tracking ring, has submitted a registration statement on Form S-1 as it moves toward an initial public offering. In the filing, the company describes a broader healthcare…
    Endpoints · 3d agoRegulatoryNeutral↗ source
  • Trump administration touts AI as solution for rural health care, experts remain skeptical
    Rural health care providers are confronting nearly $1 trillion in Medicaid cuts projected over the next decade, prompting the Trump administration to promote artificial intelligence tools as a resc…
    STAT · 4d agoNeutral↗ source
  • Medical Action Industries issues correction for epidural kits containing recalled Huons Co. lidocaine ampules
    Medical Action Industries has released a correction notice for several of its epidural kit products after discovering that they contain lidocaine ampules from Huons Co. that were previously recalle…
    fda medwatch · 4d agoCRLNeutral↗ source
  • Senator John Fetterman's post-stroke conduct sparks debate on brain health and politics
    Neurologists Michael P.H. Stanley and Isaiah Kletenik wrote an opinion piece highlighting how Senator John Fetterman's behavior after his 2022 stroke has become a focal point for discussions about…
    STAT · 4d agoNegative↗ source
  • Evommune gives up hope for MRGPRX2 antagonist to treat itch after latest phase 2 fail
    Evommune’s MRGPRX2 antagonist has flunked another phase 2 trial, wiping out the biotech’s last hopes of developing the therapy for any itch-related conditions.
    Fierce Biotech · 5d agoNegative readoutNegative↗ source
  • ARPA-H commits $62.7 million to develop FDA-authorized AI for heart-failure treatment
    ARPA-H announced a $62.7 million investment to create artificial-intelligence systems that can assist in treating heart failure. The program, called ADVOCATE, seeks to develop partially autonomous…
    STAT · 4d agoDealPositive↗ source
  • Scientists who discovered orexin receive Lasker Award as FDA appoints permanent heads of key drug and biologics centers
    The team that identified the orexin system has been honored with a Lasker Award, one of the nation’s most prestigious biomedical recognitions. The award highlights the impact of their work on under…
    STAT · 4d agoPositive↗ source
  • AstraZeneca's COPD drug cuts flare-ups in late-stage trials, offering new option for patients
    In two late-stage studies, an AstraZeneca therapy showed a statistically significant reduction in acute exacerbations that worsen chronic obstructive pulmonary disease. The data, released on Tuesda…
    STAT · 4d agoPositive readoutPositive↗ source