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  • Pentagon removes WuXi AppTec from Chinese military companies list, but risk of redesignation remains
    The U.S. Department of Defense announced that WuXi AppTec, a Shanghai-based contract research and manufacturing firm, has been taken off the Pentagon’s list of Chinese entities tied to the People’s…
    Endpoints · 10h agoRegulatoryNeutral↗ source
  • Cardinal Health updates use instructions for Presource kits with BD Alaris infusion sets
    Cardinal Health has sent a letter to customers updating the use instructions for its Presource convenience kits that contain BD Alaris pump infusion sets. The update does not call for removal of t…
    fda medwatch · 1d agoCRLNeutral↗ source
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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 · 20h agoDealNeutral↗ 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
  • Vir Biotechnology reports positive results for hepatitis D combo in first pivotal trial
    Vir Biotechnology announced that its chronic hepatitis D treatment met its primary goal in the first of three late‑stage studies. The trial evaluated a once‑monthly combination therapy that include…
    Endpoints · 1d agoPositive readoutPositive↗ source
  • FDA opens investigation into Novartis' Zolgensma after cancer cases reported
    The U.S. Food and Drug Administration announced on Friday that it is opening a formal investigation into the gene-therapy product Zolgensma, marketed by Novartis for spinal muscular atrophy. The a…
    Endpoints · 2d agoRegulatoryNegative↗ source
  • Novo and Novartis see heart drug setbacks as trials show minimal efficacy
    Novo's cardiovascular candidate failed to demonstrate meaningful benefit in its pivotal study, causing the company's shares to fall about 9% in July. The trial data showed the drug had little effe…
    Endpoints · 2d agoNegative readoutNegative↗ source
  • Democrats Take House, Raising Questions for Biopharma Policy
    Democrats secured control of Congress in a wave election held on Tuesday, shifting the political balance in Washington. The change is expected to influence the regulatory landscape for the biophar…
    Endpoints · 2d agoRegulatoryNeutral↗ source
  • Harvard scientist George Church quits AI startup Radical, alleging partner stole his credit
    George Church, a prominent Harvard researcher known for advising biotech and synthetic biology ventures, has stepped down from his role at the artificial‑intelligence startup Radical. In a public…
    Endpoints · 3d agoNegative↗ source
  • FDA probes cancer risk from Zolgensma gene therapy after post-marketing tumor reports
    The FDA has issued a safety communication indicating it is investigating reports of malignancies in patients treated with Zolgensma, the adeno‑associated virus gene therapy for spinal muscular atro…
    fda medwatch · 4d agoRegulatoryNegative↗ source
  • FDA grants accelerated approval to J&J's Rybrevant for recurrent head and neck cancer
    The U.S. Food and Drug Administration has issued an accelerated approval for Johnson & Johnson's antibody-drug conjugate Rybrevant targeting head and neck cancers that have returned after prior che…
    Endpoints · 3d agoApprovalPositive↗ source
  • Amgen's Repatha shows reduced heart attack risk while Satellos alters Duchenne trial endpoint
    Satellos Bioscience announced a change to the primary endpoint of its ongoing Duchenne muscular dystrophy trial of the investigational small‑molecule forazapadin, shifting focus to a measure of mus…
    Endpoints · 3d agoPositive readoutPositive↗ 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
  • Immunocore reports early data showing 70% two-year survival with brenetafusp/Kimmtrak combo in uveal melanoma
    Immunocore presented early clinical data on its bispecific T-cell engager combination brenetafusp and Kimmtrak in patients with uveal melanoma. The analysis, based on a subset of patients, indicat…
    Endpoints · 3d agoPositive readoutPositive↗ source
  • Moderna posts first profit in two years, driven by Covid-19 vaccine sales, as it refocuses on cancer vaccines
    Moderna reported a modest profit for the quarter, marking its first earnings surplus in two years. The turnaround was driven primarily by continued sales of its international Covid-19 vaccine portf…
    Endpoints · 3d agoEarningsPositive↗ 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 · 3d 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
  • Sarepta halts enrollment in confirmatory Phase 3 trial of Elevidys gene therapy for Duchenne muscular dystrophy
    Sarepta Therapeutics announced it will no longer enroll additional patients in the Phase 3 confirmatory study of its gene therapy Elevidys for Duchenne muscular dystrophy. The trial was intended t…
    Endpoints · 3d agoCRLNegative↗ 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
  • Novo and Pfizer appoint new CFOs while Alnylam sees departure of its chief commercial officer
    Novo announced the appointment of a new chief financial officer as part of its effort to improve financial leadership. The hire follows earlier reports that the company is seeking to turn a corner…
    Endpoints · 3d agoNeutral↗ source