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  • Spruce Biosciences spins out preclinical endocrinology program into new unit Adrenyx, backed by up to $50 million
    Spruce Biosciences announced it is creating a separate subsidiary to house its preclinical endocrinology research. The new company, named Adrenyx Biosciences, will focus on advancing the early-sta…
    Fierce Biotech · 21h agoDealNeutral↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 16h agoLayoffsNegative↗ source
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  • Update: FDA investigates Novartis' Zolgensma following 9 cases of tumors in treated patients
    After Novartis confirmed the reports of tumors in patients who have been treated with the spinal muscular atrophy gene therapy, the FDA will determine if any regulatory action is needed for Zolgens…
    BioSpace · 16h ago↗ source
  • Recon: FDA orders new eye risk warnings for Ozempic, Zepbound; FDA launches investigation of Novartis’ Zolgensma after cancer ca...
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 1d ago↗ source
  • Merck and Moderna report 99% manufacturing success and 42% lower recurrence risk for personalized melanoma vaccine in Phase 3 trial
    Merck and Moderna announced that their personalized mRNA cancer vaccine, combined with Keytruda, was successfully manufactured for 99% of patients enrolled in a large Phase 3 study. The trial, call…
    BioSpace · 3d agoPositive readoutPositive↗ source
  • Moderna reports 29% revenue rise as COVID vaccine sales stay steady amid global uptake
    Moderna said its quarterly revenue jumped 29% to $1.3 billion, driven by continued demand for its COVID-19 shots. The company has generated $1.8 billion in revenue so far this year, according to CF…
    BioSpace · 3d agoEarningsPositive↗ source
  • Marea Therapeutics reports promising Phase 2b results for MAR001 in hypertriglyceridemia
    Marea Therapeutics, which recently merged with oncology firm Lisata Therapeutics, disclosed data from the first part of its phase 2b trial of the drug candidate MAR001. The study enrolled patients…
    Fierce Biotech · 3d agoPositive readoutPositive↗ source
  • Boehringer targets 2027 submission of obesity drug survodutide after positive cardiovascular trial
    Boehringer Ingelheim announced that its experimental obesity therapy survodutide is moving toward regulatory filing. The move follows the drug's successful phase 3 cardiovascular outcomes study, w…
    Fierce Biotech · 3d agoPositive readoutPositive↗ source
  • Forge Biologics VP sees AI and Ohio talent driving next wave of gene therapy manufacturing
    Samantha Piteri-Molina, vice president of business and strategy at Forge Biologics, said her focus is on getting gene therapies into patients' hands. She helped steer Forge through a $620 million…
    BioSpace · 3d agoPositive↗ source
  • Agios cuts over 35% of R&D staff as FDA decision on sickle cell drug is delayed
    Agios announced it will eliminate more than 100 R&D positions, representing over a third of its research staff, after the FDA postponed a decision on its sickle cell disease candidate. The company…
    BioSpace · 3d agoLayoffsNegative↗ source
  • Sarepta CEO Sees Path to Stronger DMD Trials Amid 2025 Elevidys Setbacks
    Sarepta Therapeutics’ newly appointed chief executive Michael Severino, after a 90‑day assessment period, outlined a plan to restore the company’s leadership in the Duchenne muscular dystrophy mark…
    BioSpace · 3d agoEarningsNeutral↗ source
  • Moderna pauses norovirus vaccine trial after missing interim analysis
    Moderna announced it will not enroll a new cohort in the phase 3 trial of its mRNA-1403 norovirus vaccine. The decision follows a July interim analysis that showed the vaccine missed its predefine…
    Fierce Biotech · 3d agoNegative readoutNegative↗ source
  • Faeth Therapeutics reports 33% response rate in phase 2 endometrial cancer combo trial
    Faeth Therapeutics presented topline results from its phase 2 study of an oral combination targeting the PI3K/AKT/mTOR pathway in patients with advanced or recurrent endometrial cancer. The regimen…
    Fierce Biotech · 4d agoPositive readoutPositive↗ source
  • Merck ends Sutro partnership on IL-2 agonist MK-1484 amid routine pipeline prioritization
    Merck announced it is discontinuing development of MK-1484, an interleukin-2 agonist created in partnership with Sutro Biopharma. The drug entered clinical testing in 2022 as a monotherapy and in…
    Fierce Biotech · 4d agoNegative↗ source
  • Siemens Healthineers to spin off in‑vitro diagnostics unit as Olyrian Diagnostics, rebranding to Healthineers
    Siemens Healthineers announced it will separate its in‑vitro diagnostics division into a new standalone company called Olyrian Diagnostics. The carve‑out will run in parallel with a corporate name…
    Fierce Biotech · 4d agoDealNeutral↗ source
  • Regulators urge risk-based lifecycle approach for AI tools amid election-linked FDA uncertainty
    A panel of regulatory experts at the RAPS AI in Regulatory Conference in Barcelona urged professionals using AI tools to adopt a risk-based, life-cycle perspective rather than focusing solely on va…
    raps · 4d agoRegulatoryNeutral↗ source
  • Onchilles reports that direct tumor injection of N17350 clears distant lesions in solid tumor models
    Onchilles, a San Diego biotech, presented data on its therapeutic elastase N17350, a vaccine‑like agent injected directly into solid tumors. In preclinical studies the intratumoral injection not o…
    Fierce Biotech · 3d agoPositive readoutPositive↗ source
  • China offers pharma firms large patient pools and early efficacy signals for global drug development
    The podcast examines how China can be woven into global clinical development strategies. It highlights that China provides access to large patient populations, early efficacy signals and a potenti…
    Fierce Biotech · 3d agoPositive↗ source
  • Verdicts for Summit/Akeso, Capricor, Vertex mark FDA’s stacked November
    Also lined up are target action dates for Sanofi’s Gaucher disease therapy, GSK’s lung cancer medicine and BridgeBio’s muscular dystrophy drug.
    BioSpace · 3d agoRegulatoryNeutral↗ source
  • Axiom Biosciences pursues Hong Kong IPO and novel stem cell platform amid funding challenges
    Axiom Biosciences is charting an unconventional financing path by targeting a public listing in Hong Kong, with a long‑term goal of listing on the Nasdaq. The company is developing multiple drug d…
    Fierce Biotech · 3d agoPositive↗ source
  • Regulatory experts urge risk-based, lifecycle validation for AI tools in FDA work
    At the RAPS AI in Regulatory Conference in Barcelona, a panel of experts discussed the growing use of AI tools by regulatory professionals. They recommended a risk-based, lifecycle approach to val…
    raps · 4d agoRegulatoryNeutral↗ source
  • FDA grants accelerated approval for Rybrevant Faspro in recurrent/metastatic head and neck cancer
    The U.S. Food and Drug Administration granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carci…
    fda press · 4d agoApprovalPositive↗ source
  • RevMed's pancreatic cancer drug Rasonque generates $198M in Q3, far exceeding forecasts
    RevMed reported $198 million in revenue from its newly launched pancreatic cancer therapy Rasonque during the third quarter, roughly ten times the $19 million estimate from Truist Securities. The…
    BioSpace · 4d agoPositive readoutPositive↗ source
  • AstraZeneca reportedly bids $10 billion for metabolic biotech Rhythm Pharmaceuticals
    AstraZeneca is said to have made a $10 billion offer to acquire Rhythm Pharmaceuticals, a biotech that develops treatments for rare neuroendocrine disorders. The proposal values Rhythm at $124 per…
    BioSpace · 4d agoDealPositive↗ source
  • Novartis reports nine tumor cases in patients treated with Zolgensma gene therapy
    Novartis has confirmed that nine cases of tumors have been reported in patients who received its spinal muscular atrophy gene therapy, Zolgensma. The company says two cases are confirmed and seven…
    BioSpace · 4d agoNegative↗ source