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  • J&J reports 40% Q2 sales jump for Spravato as psychedelic rivals loom
    Johnson & Johnson said its depression nasal spray Spravato generated $584 million in worldwide revenue in the second quarter, a 40% increase from a year earlier. The company highlighted the drug as…
    BioSpace · 1mo agoEarningsNeutral↗ 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 · 1mo agoRegulatoryNeutral↗ source
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  • 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 · 1mo agoRegulatoryNeutral↗ source
  • Cue Biopharma appoints Dominic Borie as chief medical officer and head of R&D
    Cue Biopharma announced the hiring of Dr. Dominic Borie, MD, PhD, as its new chief medical officer and head of research and development. Borie joins from Kyverna Therapeutics, where he served as a…
    Fierce Biotech · 1mo agoPositive↗ 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 · 1mo agoRegulatoryNeutral↗ source
  • ‘Substantially better than before’: Why India has golden opportunity to build on innovative R&D wins
    A string of recent wins on the frontiers of novel drug development could mean that a homegrown innovation industry is within reach.
    Fierce Biotech · 1mo agoNeutral↗ source
  • Merck-Kelun ADC sac-TMT shows progression-free survival benefit with Keytruda in late-stage NSCLC trial
    Kelun-Biotech announced that its antibody‑drug conjugate sac‑TMT, developed with Merck, achieved positive Phase 3 results when paired with Keytruda in a non‑small cell lung cancer trial. The data…
    BioSpace · 1mo agoPositive readoutPositive↗ 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 · 1mo 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 · 1mo agoPositive readoutPositive↗ source
  • J&J restructures pharma supply chain, offloading sites as part of $55 B U.S. manufacturing push
    Johnson & Johnson announced it is restructuring its pharmaceutical supply chain, offloading certain sites to streamline operations as part of its $55 billion U.S. manufacturing initiative. The cha…
    BioSpace · 1mo agoPositive↗ source
  • Nobel laureate Jennifer Doudna unveils AI-driven platform to design novel gene‑editing enzymes
    Jennifer Doudna, the Nobel laureate who co‑invented CRISPR, announced a new AI‑powered platform for creating gene‑editing proteins in a paper published today in Science. The system uses computation…
    Fierce Biotech · 1mo agoPositive↗ source
  • Lonza urges biotech firms to prioritize early de-risking to streamline IND path
    In a recent interview, Jaime Okray of Lonza highlighted that emerging biotech companies are shifting focus from pure speed to early identification of development risks as they aim for an IND filing…
    Fierce Biotech · 1mo agoPositive↗ source
  • Agentic AI poised to reshape clinical development by moving beyond tools to autonomous decision-making
    Earlier this year, a colleague argued that clinical leaders should stop asking whether they have an 'AI strategy', because the question often leads to the wrong conversation. Instead, leaders are…
    Fierce Biotech · 1mo agoPositive↗ 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 · 1mo 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 · 1mo 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 · 1mo agoDealPositive↗ source
  • Axiom's stem cell therapy shows zero mortality in phase-1 trial for newborn brain injuries
    Axiom Biosciences reported that its mesenchymal stem cell (MSC) therapy achieved a 0% mortality rate over two years in a phase‑1 study of newborns with severe brain injuries. The nine‑patient trial…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ 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 · 1mo agoRegulatoryNeutral↗ source
  • Avere Therapeutics to go public via reverse merger, secures $320M to advance long-acting psoriasis pill
    Avere Therapeutics, a privately held immunology drug developer, announced a plan to become a public company through a reverse merger with NextCure. The transaction includes $320 million in new cap…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Biogen's tau-targeting Alzheimer's drug shows cognitive slowing in mid-stage trial
    Biogen reported results from its mid-stage "Celia" trial testing the experimental tau-targeting antibody BIIB080 in patients with early Alzheimer's disease. The study compared three dose levels of…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Draig Therapeutics secures $65M Series B to advance brain-drug trials
    Draig Therapeutics announced a $65 million Series B financing led by Deep Track Capital, with participation from Janus Henderson Investors, Marshall Wace and other investors. The capital will fund…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Experts say MDUFA VI draft letter improves program while addressing FDA resource limits
    Industry experts note that the draft commitment letter for the upcoming Medical Device User Fee Amendments (MDUFA VI) offers enhancements over the current framework and takes into account the FDA’s…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Cayman court orders Apple Tree Partners’ general partner to give up control of venture fund
    A Cayman Islands court ruled that Seth Harrison, the general partner of biotech venture firm Apple Tree Partners, must relinquish oversight of the fund. The order could shift management to two cour…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ source
  • BIO 2026 in San Diego features executive interviews on biotech trends and opportunities
    The BIO International Convention gathered more than 20,000 life‑science leaders in San Diego, serving as a major forum for biotech discussion. During the event, Fierce conducted a series of video…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Agenus redirects late-stage colorectal trial to pre-surgery setting, shares double; Oxford Ebola vaccine enters Phase 1
    Agenus announced it will stop financially supporting its late-stage trial of the BOT+BAL immunotherapy combination in late-line colorectal cancer. The company will instead use recent $340 million…
    BioPharma Dive · 1mo agoNeutral↗ source