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  • Reverse mergers surge as biotech firms seek public listings via shell companies
    Reverse mergers, once dismissed, are now a common route for biotech startups to gain a public listing by merging with shell companies. Data from JB Strategy Partners shows roughly two dozen such d…
    BioPharma Dive · 1d agoDealNegative↗ source
  • Roivant's mosliciguat shows strong efficacy in Phase 2 PH-ILD trial
    Roivant's experimental drug mosliciguat achieved strong efficacy signals in a Phase 2 study of pulmonary hypertension associated with interstitial lung disease (PH-ILD). The mid-stage trial met its…
    STAT · 1d agoPositive readoutPositive↗ source
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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 · 1d 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 · 1d agoPositive↗ source
  • 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 · 1d agoNeutral↗ 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 · 1d 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 · 22h 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 · 1d agoNegative↗ source
  • Takeda R&D chief Andy Plump to retire in June 2027, will stay on board through 2027
    Takeda announced that Andy Plump, who has led the company's research and development since 2015, will retire in June 2027. Plump will remain president of R&D until a successor is appointed and wil…
    BioPharma Dive · 1d agoNeutral↗ 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 · 1d 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 · 1d 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 · 22h agoNegative↗ 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 · 1d 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 · 1d 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 · 1d 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 · 1d agoNeutral↗ 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 · 1d agoNeutral↗ 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 · 1d 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 · 2d 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 · 2d 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 · 2d 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 · 2d agoPositive readoutPositive↗ source
  • Solstice Oncology secures $225M Series A to advance CTLA-4 antibody porustobart in colon cancer
    Solstice Oncology, a biotech startup focused on immunotherapy, announced it has raised $225 million in a Series A financing round. The funding will support development of its lead candidate, a CTL…
    BioPharma Dive · 2d agoDealPositive↗ source
  • Luma Group closes $410 million, 15-year life-science venture fund
    Luma Group announced that its first life‑science venture capital fund has reached final close, raising $410 million for a 15‑year investment period. The New York‑based firm said the capital will be…
    Fierce Biotech · 2d agoDealPositive↗ source
  • Encoded Therapeutics secures $275M Series F to push Dravet gene therapy and expand manufacturing
    Encoded Therapeutics, a biotech focused on neuro‑genetic disorders, announced a $275 million Series F financing round. The capital was co‑led by Google Ventures and an undisclosed healthcare fund,…
    Fierce Biotech · 2d agoDealPositive↗ source