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  • Bristol Myers teams with Nvidia to launch large AI data center as Samsung Biologics bids $1.8 bn for Swiss peptide maker
    Bristol Myers Squibb announced expansion of its partnership with Nvidia, deploying two AI systems to create a powerful AI factory for life‑science research, aiming to tackle larger problems without…
    BioPharma Dive · 3mo agoDealNeutral↗ source
  • Australia's TGA opens consultation to revamp rules for digital mental health tools
    The Therapeutic Goods Administration (TGA) has launched a public consultation aimed at updating the regulatory framework that governs digital mental health tools in Australia. The move seeks to cla…
    raps · 3mo agoRegulatoryNeutral↗ source
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  • FDA approves Lipfendra, first oral PCSK9 inhibitor, to lower LDL cholesterol in adults
    The U.S. Food and Drug Administration has approved Lipfendra (enlicitide), the first oral inhibitor of the PCSK9 protein, for use as an adjunct to diet and exercise in adults with high cholesterol,…
    fda press · 3mo agoApprovalPositive↗ source
  • Compounders still supply about 20% of US GLP-1 weight-loss market despite FDA crackdown and shortages
    A recent Gallup survey shows that while the number of Americans taking GLP-1 weight‑loss drugs has nearly quadrupled over the past two years, roughly one in five are using cheaper, non‑FDA‑approved…
    BioPharma Dive · 3mo agoRegulatoryNegative↗ source
  • GSK drops camlipant cough drug after mixed Phase 3 results
    GSK announced it is halting development of camlipant, an experimental chronic cough medicine it acquired in a $2 billion purchase three years ago. The decision follows two Phase 3 trials that show…
    BioPharma Dive · 3mo agoNegative readoutNegative↗ source
  • Jasper Therapeutics secures $132 million and merges with Kira Pharmaceuticals to revive pipeline
    Jasper Therapeutics, a cash‑strapped biotech, announced it completed an all‑stock acquisition of privately held immune‑drug developer Kira Pharmaceuticals. The merger is paired with a private stoc…
    BioPharma Dive · 3mo agoDealPositive↗ 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
  • 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
  • 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
  • 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 · 4mo 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 · 4mo 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 · 4mo agoApprovalPositive↗ 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 · 4mo agoPositive readoutPositive↗ 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 · 4mo 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 · 4mo 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 · 4mo agoRegulatoryNeutral↗ 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 · 4mo agoApprovalNegative↗ source
  • Merck's sac-TMT shows promise in Chinese Phase 3 lung cancer trial, may replace chemo
    Merck and its Chinese partner Kelun-Biotech reported that the antibody-drug conjugate sac-TMT slowed disease progression better than a standard chemotherapy regimen in a Phase 3 trial conducted in…
    BioPharma Dive · 4mo agoPositive readoutPositive↗ source
  • J&J shares fall 3% as oncology sales miss forecasts, while AstraZeneca invests $600M in lung cancer drug
    Johnson & Johnson’s stock slipped about 3% on Wednesday even though the company raised its full‑year sales outlook. In its latest quarterly earnings release the firm said revenue in its innovative…
    BioPharma Dive · 4mo agoEarningsNeutral↗ source
  • FDA acting commissioner says Makary’s journal policies are not official guidance; UK regulator reports rise in drug approvals and AI steps
    The acting commissioner of the U.S. Food and Drug Administration clarified that the policies published in medical journals by former commissioner Marty Makary do not constitute official FDA policy…
    raps · 4mo agoRegulatoryNeutral↗ source
  • Attovia Therapeutics and Braveheart Bio announce plans for biotech IPOs amid market upswing
    Attovia Therapeutics and Braveheart Bio disclosed on Tuesday that they intend to go public, joining a recent wave of large biotech offerings. Attovia, which was spun out of Alamar Biosciences in 2…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • FDA Grants Emergency Use Authorization for Ivermectin Liquid to Prevent New World Screwworm in Horses
    The U.S. Food and Drug Administration has issued an Emergency Use Authorization for an ivermectin oral solution intended for horses, aimed at preventing infestations by New World screwworm. The au…
    fda press · 4mo agoRegulatoryNeutral↗ source
  • CVS Caremark settles FTC antitrust case, agreeing to favor lowest-cost insulin on formularies
    CVS Caremark announced a settlement with the Federal Trade Commission that resolves the agency’s antitrust lawsuit alleging the PBM favored higher-priced insulin versions. Under the agreement, Car…
    BioPharma Dive · 4mo agoRegulatoryNeutral↗ source