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  • GSK to launch large trial testing shingles vaccine’s potential to reduce Alzheimer’s risk
    GSK announced it will conduct a large-scale clinical study to evaluate whether the shingles vaccine can lower the risk of developing Alzheimer’s disease. The move follows observations from analyses…
    Endpoints · 3mo agoNeutral↗ source
  • Arbutus and Sanofi launch new patent lawsuits against Pfizer, BioNTech and Moderna over mRNA lipid nanoparticle technology
    Arbutus BioPharma filed three new lawsuits against Pfizer and BioNTech, accusing them of infringing patents covering the lipid nanoparticle (LNP) technology used to deliver mRNA vaccines. The filin…
    BioPharma Dive · 3mo agoRegulatoryNegative↗ source
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  • AI-discovered drugs show early promise but face mixed results in clinical trials
    AI is being promoted as a way to cut the cost and time of drug research and development, which can exceed $2.6 billion and take up to 15 years. Only a handful of AI‑identified compounds have enter…
    BioPharma Dive · 3mo agoNeutral↗ source
  • GSK halts Phase 3 chronic cough drug camlipixant, jeopardizing $2 billion Bellus Health acquisition
    GSK announced it is ending development of camlipixant, a drug aimed at treating refractory chronic cough, after completing Phase 3 trials. The move comes as the company proceeds with its planned $…
    Endpoints · 3mo agoNegative↗ source
  • FDA proposal to drop adequate provision could effectively ban prescription drug ads
    FDA staff are proposing to eliminate the adequate provision requirement in direct-to-consumer prescription-drug advertisements. The adequate provision currently obliges advertisers to present a bal…
    raps · 3mo agoRegulatoryNegative↗ source
  • Pharma industry backs FDA NGS guidance but seeks clarification on off-target data and manufacturing changes
    The pharmaceutical sector has broadly endorsed the FDA's recent guidance on using next‑generation sequencing to evaluate the safety of human gene‑therapy products. Despite this support, companies…
    raps · 3mo agoRegulatoryNeutral↗ source
  • FDA staff flag peptide conflict concerns and warn drug ad rule could curb advertising
    FDA staff have raised internal concerns about potential conflicts of interest among experts who will sit on an upcoming advisory panel reviewing peptide therapies. The staff memo warns that undiscl…
    raps · 3mo agoRegulatoryNegative↗ source
  • Dimerix acquires Mission’s acute kidney injury candidate for $5 million upfront
    Dimerix announced it has signed a deal to acquire a kidney injury drug candidate from Mission Therapeutics. The asset is ready to enter Phase 2 trials for the treatment of acute kidney injury. Und…
    Endpoints · 3mo agoDealPositive↗ source
  • Zealand Pharma appoints former Lilly executive as US marketing head
    Silvia Luque announced on LinkedIn that she will lead US marketing for Zealand Pharma. The appointment follows a 13-year tenure at Eli Lilly, where she held several roles in the company's obesity f…
    Endpoints · 3mo agoNeutral↗ source
  • Eli Lilly to buy psychedelics biotech AtaiBeckley for $2.8 billion, adding late-stage depression drug
    Eli Lilly announced it will acquire New York‑based biotech AtaiBeckley in a transaction valued at about $2.8 billion. The agreement sets the purchase price at $6.75 per share, a 26 % premium to At…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • Merck's Lipfendra pill receives FDA approval as first oral PCSK9 cholesterol treatment
    The U.S. Food and Drug Administration approved Lipfendra, an oral medication from Merck that lowers low density lipoprotein cholesterol. The drug blocks the PCSK9 protein, making it the first pill…
    BioPharma Dive · 3mo agoApprovalPositive↗ source
  • Merck secures US approval for the first oral PCSK9 cholesterol-lowering pill, edging out AstraZeneca
    Merck has received the United States regulatory clearance for an oral PCSK9 inhibitor, marking the first time a pill of this class has been approved for cholesterol management. The approval comes…
    Endpoints · 3mo agoApprovalPositive↗ source
  • CDER plans new guidance on AI, electronic safety report submissions, and more
    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has updated its list of new and revised guidance documents it plans to issue this year to include four new…
    raps · 3mo agoApprovalPositive↗ source
  • US drug shortages climb for third consecutive quarter, many rely on single suppliers
    The latest data show that the count of medicines in shortage across the United States increased again in the most recent quarter, marking the third straight period of growth. Analysts note that ne…
    Endpoints · 3mo agoNegative↗ source
  • Mirador Therapeutics announces partnership to acquire Kira drug, positioning it against Tavneos
    Mirador Therapeutics, a San Diego‑based biotech focused on immune diseases and backed by more than $650 million in venture capital, has disclosed a new element of its development pipeline. The com…
    Endpoints · 3mo agoDealPositive↗ source
  • Veradermics' experimental hair loss pill shows promising results in women
    Veradermics reported positive Phase 2 data for its oral minoxidil formulation VDPHL01 in women with mild-to-moderate pattern hair loss. The study enrolled 28 participants who took the drug once or…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • Alzheimer researcher Betty Tijms urges broader view beyond amyloid and tau
    Betty Tijms, head of science at the Alzheimer Center Amsterdam, says it is time to stop treating Alzheimer’s as a single disease. For more than a century, research has focused on two proteins, amy…
    Endpoints · 3mo agoNeutral↗ source
  • Sanofi sues Pfizer and Moderna over alleged infringement of mRNA delivery patents
    Sanofi has filed a lawsuit against Pfizer and Moderna, accusing the two companies of violating its patents covering lipid nanoparticle technology used to deliver mRNA in vaccines. The French drugm…
    Endpoints · 3mo agoRegulatoryNegative↗ source
  • Eli Lilly to acquire AtaiBeckley for $2.8 billion, signaling deeper bet on psychedelics
    Eli Lilly announced on Thursday that it will acquire psychedelic drug developer AtaiBeckley. The purchase price is set at $2.8 billion paid upfront. The sizable upfront payment highlights Lilly's…
    Endpoints · 3mo agoDealPositive↗ source
  • Stakeholders urge FDA to create drug-repurposing framework that avoids disincentives and stays within authority
    Stakeholders, including patients and healthcare industry groups, told the FDA that repurposing existing drugs offers significant opportunities for new treatments. They warned that any new repurpos…
    raps · 3mo agoRegulatoryNeutral↗ source
  • EMA issues guidance to curb microbial contamination in non-sterile medicines; MHRA reports record drug approvals
    The European Medicines Agency has issued new guidance that outlines technical and organisational measures to reduce the risk of microbial contamination in non-sterile pharmaceutical products. The…
    raps · 3mo agoRegulatoryNeutral↗ source
  • UK regulator reports rise in drug approvals and steps toward AI oversight in healthcare
    The UK Medicines and Healthcare products Regulatory Agency (MHRA) released its 2025-2026 annual report to Parliament. The agency highlighted that it approved more new medicines this year than in t…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Kelun-Biotech reports first-line success of Merck-partnered ADC sacituzumab tirumotecan in China
    Kelun-Biotech announced that its antibody‑drug conjugate sacituzumab tirumotecan, developed in partnership with Merck, achieved its primary efficacy endpoints when used as a first‑line therapy in a…
    Endpoints · 3mo agoPositive readoutNeutral↗ source
  • Reporter attends AHA Leadership Summit in Denver to gauge hospital executives' priorities
    The author attended the American Hospital Association’s Leadership Summit in downtown Denver earlier this week. While there, the author handed out ice cream recommendations to attendees. The prim…
    Endpoints · 3mo agoNeutral↗ source
  • Celcuity receives FDA approval for Revtorpyk, a breast cancer therapy, but shares drop nearly 20% amid launch delay concerns
    Celcuity announced that the U.S. Food and Drug Administration cleared its breast cancer drug Revtorpyk for use in combination with hormone therapy and Pfizer's Ibrance in patients with ER-positive,…
    BioPharma Dive · 3mo agoApprovalNegative↗ source