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  • 'Still a bull': Novo's CEO on honoring heritage and planning for the future amid corporate rebrand
    Novo CEO Mike Doustdar—tapped to breathe new life into the Danish drugmaker last year after losing GLP-1 marketing ground to chief rival Eli Lilly—isn’t one to make changes for the sake of change.
    Fierce Biotech · 1mo agoRegulatoryNeutral↗ source
  • Experts assess EU medical device and diagnostic regulations at RAPS Convergence 2026
    A panel of experts representing the European Commission, industry groups and notified bodies gathered in Charlotte, North Carolina during RAPS Convergence 2026. The group reviewed the current stat…
    raps · 1mo agoRegulatoryNeutral↗ source
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  • Novartis to pay $125M for blood-brain barrier crossing platform
    Proceeds from the deal, which hands Novartis global rights to a technology developed by Sironax, will help advance three candidates that the startup says have “best-in-class” potential.
    BioPharma Dive · 1mo ago↗ source
  • Sling banks $123M for an experimental thyroid eye disease pill
    A confirmatory late-stage study is now also underway for what the startup is positioning as, potentially, the first oral alternative to approved injectables like Amgen's Tepezza and Viridian's Lumvoa.
    BioPharma Dive · 1mo ago↗ source
  • FDA approves first generic radioligand therapy for neuroendocrine tumors as Sionna announces major layoffs
    The U.S. Food and Drug Administration has cleared Bexlutry, the first generic version of Novartis’ Lutathera, marking the debut of a radioligand therapy that can be used for SSTR‑positive neuroendo…
    BioPharma Dive · 2mo agoApprovalNeutral↗ source
  • GSK licenses Chimagen trispecific T-cell engager for up to $750 million, targeting phase-1 multiple myeloma study
    GSK has entered a licensing agreement with China’s Chimagen Biosciences that could be worth as much as $750 million. The deal will allow GSK to begin phase‑1 testing of a trispecific T‑cell engager…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • New antibody-drug conjugates show promise as potential standard for extensive-stage small cell lung cancer at WCLC 2026
    The World Conference on Lung Cancer showcased several late‑stage trial updates, with a focus on new therapies for small cell lung cancer, the more aggressive form of the disease. Antibody‑drug con…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • FDA approves Telix's Pixclara, first FET-PET imaging drug for glioma in the U.S.
    The U.S. Food and Drug Administration has granted approval to Telix Pharmaceuticals' Pixclara, a fluorine‑18 labeled amino acid PET tracer designed for imaging gliomas. This marks the first FDA‑cle…
    Fierce Biotech · 2mo agoRegulatoryPositive↗ source
  • Johnson & Johnson’s depression drug JNJ-5120 fails primary endpoint in phase 2 trial
    A phase 2 study of JNJ-5120, an M1 receptor antagonist developed by Johnson & Johnson with Contineum Therapeutics, did not meet its primary efficacy endpoint in patients with major depressive disor…
    Fierce Biotech · 2mo agoNegative readoutNegative↗ source
  • Sling Therapeutics raises $123M Series C to advance oral thyroid eye disease drug into Phase 3
    Sling Therapeutics announced a $123 million Series C financing round aimed at moving its oral therapy for thyroid eye disease into a late‑stage trial and eventual market launch. The company has be…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • FDA launches pilot to accelerate early-stage drug trials in the United States
    The FDA announced a new pilot program called the Expedited Investigational New Drug Pilot as part of Operation Trialblazer. The initiative will pair up to ten qualified research institutions with…
    BioPharma Dive · 2mo agoRegulatoryPositive↗ source
  • FDA opens pilot to accelerate phase 1 trials with fast IND reviews
    The Food and Drug Administration announced a new pilot program aimed at speeding up early-stage clinical trials in the United States. The initiative pairs drug sponsors with qualified research inst…
    Fierce Biotech · 2mo agoRegulatoryPositive↗ source
  • Mayo Clinic and Thermo Fisher launch Precure to build large biomedical data set
    Mayo Clinic has partnered with Thermo Fisher Scientific to form Precure LLC, a new group focused on creating one of the largest biomedical data sets using human multi‑omics data. Precure will inte…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Eli Lilly partners with QurCan Therapeutics, pledging up to $237 M per CNS genetic-medicine program
    Eli Lilly announced a collaboration with Canadian biotech QurCan Therapeutics to advance genetic medicines aimed at the central nervous system. Under the deal, Lilly will provide up to $237 millio…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Sionna Therapeutics cuts 46% of staff after cystic fibrosis trial miss
    Sionna Therapeutics announced it will lay off roughly half of its employees as it reassesses its strategy following a recent setback in its cystic fibrosis program. The company’s lead candidate, S…
    Fierce Biotech · 2mo agoLayoffsNegative↗ source
  • FDA launches pilot program to speed early-phase drug trials
    The U.S. Food and Drug Administration announced a new pilot program aimed at accelerating the review of Phase 1 clinical trials for investigational new drugs. The initiative introduces a rolling s…
    raps · 2mo agoRegulatoryPositive↗ source
  • Experts urge FDA to establish safety and access guidelines for psychedelic drugs; GSK to close German vaccine plant
    Experts are urging the U.S. Food and Drug Administration to set clear safety and access standards for psychedelic medicines, according to the briefing. The request reflects growing interest in the…
    raps · 2mo agoRegulatoryNeutral↗ source
  • Connect Biopharma's asthma drug rademikibart misses primary endpoint in Phase 2 trial
    Connect Biopharma reported that its IL-4/IL-13 blocker rademikibart failed to meet the primary endpoint in a Phase 2 study in asthma patients with type-2 inflammation. The trial enrolled 160 patie…
    Fierce Biotech · 2mo agoNegative readoutNegative↗ source
  • Novo abandons $285 million partnership with Ascendis for monthly GLP-1 obesity drug
    Novo Nordisk, which recently rebranded, has terminated a licensing agreement with Ascendis Pharma that was originally valued at up to $285 million. The collaboration, signed in November 2024, was…
    Fierce Biotech · 2mo agoDealNegative↗ source
  • FDA issues warning letters to Bausch & Lomb and Indian API maker over GMP lapses
    The U.S. Food and Drug Administration sent warning letters to two companies after finding violations of good manufacturing practice. Bausch & Lomb, which produces ophthalmic products, was cited f…
    raps · 2mo agoRegulatoryNegative↗ source
  • Jaguar LAA acquires Johnson & Johnson's Laminar atrial fibrillation device assets
    Jaguar LAA, a newly formed medtech company, announced it has purchased assets related to Johnson & Johnson's Laminar atrial fibrillation device program. The Laminar technology is a catheter‑based…
    Fierce Biotech · 2mo agoDealNeutral↗ source
  • Experts review five decades of regulatory evolution at RAPS Convergence 2026
    At the opening plenary of RAPS Convergence 2026 in Charlotte, NC, specialists in medical device and pharmaceutical regulatory affairs gathered to discuss the field’s trajectory. They reflected on…
    raps · 2mo agoRegulatoryNeutral↗ source
  • Summit and Akeso report ivonescimab extends lung cancer survival by eight months versus Keytruda in Phase 3 trial
    Summit Therapeutics and its partner Akeso said their experimental dual-target drug ivonescimab added about eight months of overall survival for patients with lung cancer compared with Merck's Keytr…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • AstraZeneca’s newly approved pill fails frontline breast cancer study
    Etcamah is the second oral “SERD” to recently fall short in first-line breast cancer, following a similar setback from Roche earlier this year.
    BioPharma Dive · 2mo agoApprovalPositive↗ source
  • FDA approves Scholar Rock's muscle-targeted SMA therapy Isembyld
    The Food and Drug Administration has approved a new medication for spinal muscular atrophy (SMA). The drug, apitegromab marketed as Isembyld, is the first muscle-targeted therapy for the disease.…
    BioPharma Dive · 2mo agoApprovalPositive↗ source