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  • 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
  • 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 · 3d agoRegulatoryNeutral↗ source
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  • RevMed stock rises on early Rasonque sales as whistleblower sues Madrigal over MASH safety
    RevMed announced its first sales figures for Rasonque, a therapy targeting pancreatic cancer, and the news sent the company's shares higher. The company said the early sales data reflect market up…
    Endpoints · 4d agoNeutral↗ source
  • Caldera and Evommune secure China licensing agreements for autoimmune drug assets
    Caldera and Evommune announced they have entered licensing agreements with Chinese partners to bring their autoimmune drug programs to the Chinese market. The deals come as the biopharma sector is…
    Endpoints · 4d agoDealPositive↗ source
  • Merck reports positive mid-stage results for Hanmi-licensed MASH drug
    Merck announced Thursday that its dual GLP-1/glucagon agonist, which it licensed from South Korea’s Hanmi Pharmaceutical in 2020, has met its primary endpoints in a mid-stage trial for metabolic dy…
    Endpoints · 4d agoPositive readoutPositive↗ source
  • Alethio Therapeutics raises $90 million Series A to develop antibody for essential thrombocythemia
    Alethio Therapeutics, a spinout from the University of Oxford, announced a $90 million Series A financing round. The capital will fund the company’s lead program, an antibody designed to treat ess…
    Endpoints · 4d agoDealPositive↗ source
  • T-Therapeutics raises $133 million from Sanofi, J&J, Merck KGaA and Eli Lilly for TCR cancer and autoimmune programs
    T-Therapeutics, a UK biotech focused on T-cell receptor therapies for cancer and autoimmune diseases, announced it has raised $133 million in financing. The round is led by Sanofi with participati…
    Endpoints · 4d agoDealPositive↗ source
  • MDCG issues guidance on clinical evidence for orphan in-vitro diagnostics
    The Medical Device Coordination Group (MDCG) has published new guidance that explains how clinical evidence requirements apply to orphan in-vitro diagnostics (IVDs). The document is intended to he…
    raps · 4d agoRegulatoryNeutral↗ source
  • New treatments for preeclampsia move closer to patients
    Emily Chaddock’s experience highlights the danger of severe preeclampsia, a pregnancy complication that can threaten both mother and baby. At 27 weeks she developed the condition, leading to a rapi…
    Endpoints · 4d agoPositive↗ source
  • Experts urge streamlined EU AI framework and higher regulatory literacy for healthcare products
    Experts speaking at the RAPS AI in Regulatory Conference in Barcelona called for a more streamlined artificial intelligence framework for healthcare products across Europe. They said the current r…
    raps · 4d agoRegulatoryNeutral↗ source
  • FDA official says midterm elections unlikely to delay user fee reauthorization for FY 2028-2032
    A senior FDA official indicated that the recent midterm election results are not expected to interfere with the upcoming renewal of the agency’s user fee contracts covering fiscal years 2028 throug…
    raps · 4d agoRegulatoryNeutral↗ source
  • AAFP chief urges Congress to add oversight to CDC vaccine advisory panel
    Shawn Martin, CEO of the American Academy of Family Physicians, said the CDC’s Advisory Committee on Immunization Practices (ACIP) has faced more than a year of turmoil. He is urging Congress to e…
    Endpoints · 4d agoRegulatoryNeutral↗ source
  • Ellipsis Health acquires Kouper Health to expand AI voice call capabilities
    Ellipsis Health, a startup that builds voice-based artificial intelligence tools for healthcare, announced it has purchased Kouper Health. The deal reflects growing interest in AI systems that can…
    Endpoints · 4d agoDealNeutral↗ source
  • Seven new tumor cases reported among patients on Novartis' Zolgensma gene therapy
    Nine patients who have received Novartis' spinal muscular atrophy gene therapy Zolgensma have developed tumors following their treatment, the company confirmed Thursday. Seven of those cases were d…
    Endpoints · 4d ago↗ source
  • Recon: Sino, Boehringer ink cancer drug deal worth $7B; CVS to split pharmacy business from insurance
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 4d ago↗ source
  • Boehringer Ingelheim partners with Sino Biopharma on $7 billion cancer drug deal
    Boehringer Ingelheim announced a partnership with China's Sino Biopharmaceutical to co-develop cancer therapies. The agreement targets antibody-drug conjugates and T-cell engager platforms, with a…
    Endpoints · 5d agoDealPositive↗ source
  • CVS Health to split into two publicly traded companies, separating pharmacy and insurance units
    CVS Health announced a plan to divide the company into two separate publicly listed entities. One entity will keep the CVS Health name and encompass the pharmacy retail and pharmacy benefit manage…
    Endpoints · 5d agoDealNeutral↗ source
  • Novo falls behind Eli Lilly in market race as investors react to Q3 results
    A year ago the competition between Eli Lilly and Novo was described as the fiercest in the industry. Recent commentary suggests the rivalry has become increasingly one‑sided, with Novo struggling t…
    Endpoints · 5d agoNegative↗ source
  • China rises on biotech risk list as US draft rules threaten Chinese biopharma investments
    A recent Signal Survey shows China moving up the biotech industry’s concern list even before the Treasury Department issued draft rules that could curb U.S. investment in Chinese biopharma. The pr…
    Endpoints · 5d agoRegulatoryNegative↗ source
  • First wave of ASH 2026 abstracts released, featuring data from J&J, Servier and AstraZeneca
    The American Society of Hematology’s annual meeting is set for New Orleans, Louisiana, a little over a month away. The first batch of abstracts for the conference has been posted, showcasing early…
    Endpoints · 5d agoNeutral↗ source
  • AbbVie licenses Nxera's EP4 gut-targeting IBD program for up to $1.47 billion
    AbbVie announced a licensing agreement with Nxera Pharma to acquire rights to its EP4 receptor agonist program aimed at inflammatory bowel disease. The deal includes an upfront payment of $100 mil…
    Endpoints · 5d agoDealPositive↗ source
  • Novo projects flat 2026 sales as CFO exits, marking an upgrade from prior expectations
    Novo announced that its 2026 sales outlook will be flat, a shift from earlier growth expectations. The drugmaker also disclosed that its chief financial officer will be leaving the company, and a…
    Endpoints · 5d agoNeutral↗ source
  • Minghui Pharma sells Japanese rights to its Phase 3 thyroid eye disease drug for $110 million upfront
    Minghui Pharmaceutical, a Shanghai‑based biotech, has agreed to transfer the Japanese commercial rights for its late‑stage thyroid eye disease candidate to a specialty pharmaceutical company. The…
    Endpoints · 5d agoDealPositive↗ source
  • FDA urges biosimilar sponsors to use alternative efficacy studies while AI reshapes regulatory work
    AI is becoming common in regulatory work. Experts say it will not replace regulatory professionals but will help them work more efficiently and free up time for human interaction. They stress that…
    raps · 5d agoRegulatoryNeutral↗ source
  • Spyre Therapeutics reports SPY072 fails psoriatic arthritis trial as Ideaya halts eye cancer study
    Spyre Therapeutics announced that its long‑acting anti‑TL1A candidate, SPY072, did not meet the primary endpoints in a psoriatic arthritis trial. The result adds to recent setbacks for Spyre in ot…
    Endpoints · 5d agoNegative readoutNegative↗ source