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  • 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 · 1mo 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 · 1mo agoRegulatoryNeutral↗ source
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  • GSK to cut 650 jobs as it shuts German vaccine plant and consolidates production in Canada
    GSK announced it will close its vaccine manufacturing facility in Dresden, Germany, resulting in about 650 layoffs. The decision follows a review and aligns with a $2.5 billion cost‑saving program…
    BioSpace · 1mo agoLayoffsNegative↗ 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 · 1mo 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 · 1mo 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 · 1mo agoRegulatoryNegative↗ source
  • Rare disease reform, CMC risk, reshoring US trials top of mind ahead of PDUFA VIII meeting
    The FDA gathers Wednesday to hear what industry stakeholders and the public want included in the latest iteration of the Prescription Drug User Fee Act that sets the agency’s priorities for fiscal…
    BioSpace · 1mo agoRegulatoryNeutral↗ 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 · 1mo 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 · 1mo agoRegulatoryNeutral↗ source
  • AstraZeneca’s Etcamah fails Phase 3 trial, dashing hopes for $2.9 billion breast cancer market
    AstraZeneca’s oral selective estrogen receptor degrader Etcamah was evaluated in the Phase 3 SERENA-4 trial as a first-line option for patients with ER-positive, HER2-negative advanced breast cance…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • FDA approves Moderna’s mRNA flu vaccine as company reports positive Phase 3 cancer vaccine results
    The FDA has granted approval to Moderna’s mRNA‑based flu vaccine, marking a notable rebound for the technology after the Trump administration cut $500 million in funding for mRNA programs a year ea…
    BioSpace · 1mo agoApprovalPositive↗ source
  • AAM warns that price pressures threaten sustainability of US generics and biosimilars market
    The Association for Accessible Medicines (AAM) issued its annual report warning that the economics of off‑patent drugs have deteriorated, putting the sustainability of the generic and biosimilar ma…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • Scholar Rock receives FDA approval for Isembyld, first muscle-targeted SMA therapy
    Scholar Rock announced that its monoclonal antibody apitegromab, branded Isembyld, has been cleared by the FDA for treatment of spinal muscular atrophy (SMA). The approval follows a previous rejec…
    BioSpace · 1mo agoApprovalPositive↗ source
  • FDA holds hearing on access and safety as psychedelic drug approval looms
    The Food and Drug Administration convened a public hearing to collect input on how emerging psychedelic medicines should be used, monitored, and continuously studied as a potential first approval a…
    Fierce Biotech · 1mo agoRegulatoryNeutral↗ source
  • BioNTech's anti-CTLA-4 drug shows survival advantage in advanced squamous lung cancer at WCLC
    BioNTech, together with partner OncoC4, presented new overall survival data at the World Conference on Lung Cancer in South Korea, joining other companies such as Summit Therapeutics, GSK and Roche…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • Corbus reports phase 1b obesity data showing lower neuropsychiatric side effects for CB1 antagonist
    Corbus Pharmaceuticals released results from a phase 1b trial of its CB1 inverse agonist aimed at treating obesity. The study indicated the drug lowered rates of depression, anxiety, irritability a…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Cellectis drops its allogeneic CAR-T candidates lasme-cel and eti-cel amid rising competition from in-vivo therapies
    Cellectis announced it is terminating development of its two allogeneic CAR-T programs, lasme-cel for B-cell acute lymphoblastic leukemia and eti-cel for non-Hodgkin lymphoma. The move reflects a…
    Fierce Biotech · 1mo agoNegative↗ source
  • Definium's LSD candidate DT120 shows positive Phase 3 results, moving toward FDA submission
    Definium Therapeutics reported positive topline data from its Phase 3 Panorama trial of DT120, an oral LSD formulation for generalized anxiety disorder (GAD). The trial met its primary endpoint, s…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • Novo drops Nordisk from name, rebrands as Novo with new bull logo
    Novo Nordisk announced it will drop the "Nordisk" part of its name, rebranding simply as Novo and rotating the iconic Apis bull in its logo to signal a new direction. CEO Mike Maziar Doustdar said…
    BioSpace · 1mo agoNeutral↗ source
  • Eli Lilly halts early-stage obesity drug LY4064912 after failing to meet development criteria
    Eli Lilly announced it is ending development of its early-stage obesity candidate, LY4064912, after the phase 1 study did not achieve the company’s expectations. The first‑in‑human trial enrolled…
    Fierce Biotech · 1mo agoNegative↗ source
  • Electra Therapeutics targets up to $342M IPO to fund phase 2/3 study of ipsoprubart for rare inflammatory syndrome
    Electra Therapeutics, based in South San Francisco, filed with the SEC indicating plans to sell 21.7 million shares at $14‑$16 each. The company expects net proceeds of about $296.6 million, poten…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • Roche-MediLink’s B7-H3 ADC meets primary endpoint in phase 3 SCLC trial, median survival 13.3 months
    Roche and its partner MediLink reported phase 3 results for the B7-H3-directed antibody-drug conjugate (ADC) in small-cell lung cancer. The trial met its primary endpoint, with a median overall sur…
    Fierce Biotech · 1mo agoPositive readoutNeutral↗ source
  • Public backing fuels FDA hearing on psychedelic therapies and potential COMP360 approval
    The FDA is holding a hearing on Monday to discuss the future of psychedelic drug development, after a wave of public comments expressed strong support for further research. Analysts say the suppor…
    BioSpace · 1mo agoRegulatoryPositive↗ source
  • Merck and Moderna’s melanoma vaccine success spurs five rivals to chase personalized cancer vaccine breakthrough
    Merck and Moderna announced that their mRNA‑based cancer vaccine, given together with Merck’s Keytruda, extended progression‑free survival in patients with cutaneous melanoma in a late‑stage trial.…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • FDA appoints new oncology chief, pledges ongoing innovation; approves treatments for two rare genetic disorders
    The Food and Drug Administration has announced a new leader for its Oncology Center of Excellence. The appointee emphasized a continued focus on innovative cancer therapies and collaborative resear…
    raps · 1mo agoRegulatoryPositive↗ source