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  • Live discussion to assess how US midterm elections could reshape biopharma policy
    Drew Armstrong, executive editor of PharmaFDA+, announced a live webcast at 1:30 pm ET on November 3, 2026 to discuss the impact of the US midterm elections on biotech and pharma. The program will…
    Endpoints · 5d agoNeutral↗ source
  • Merck KGaA sells its CDMO business and US sites to Lonza
    Merck KGaA announced it will divest its contract development and manufacturing organization (CDMO) operations, transferring ownership of five U.S. manufacturing facilities to Lonza. The transactio…
    Endpoints · 6d agoDealNeutral↗ source
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  • Legal experts advise European healthcare manufacturers on navigating complex environmental regulations
    At the RAPS Regulatory Intelligence Conference Europe in Barcelona, two legal specialists highlighted the difficulty of Europe’s environmental and sustainability rules for companies that make healt…
    raps · 6d agoRegulatoryNeutral↗ source
  • FDA reports rise in unannounced drug inspections in China and India for FY 2026
    A senior FDA enforcement official said the agency carried out more surprise drug facility inspections in India and China during fiscal year 2026 than it did in the prior year. The unannounced visi…
    raps · 6d agoRegulatoryNeutral↗ source
  • Stakeholders submit over 500 comments urging FDA to shape regulation of generative AI medical devices
    Over 500 comments have been filed in response to the FDA's discussion paper on generative AI-enabled medical devices. The feedback reflects a wide range of viewpoints. Some participants recommend…
    raps · 6d agoRegulatoryNeutral↗ source
  • Bayer CEO says company is negotiating a most-favored-nation trade pact with US administration
    Bayer chief executive Bill Anderson announced the drugmaker is actively pursuing a most-favored-nation (MFN) agreement with the United States. The comment signals that Bayer is in talks with the T…
    Endpoints · 6d agoRegulatoryNeutral↗ source
  • Pfizer CEO says Democratic gains unlikely to alter Trump-era MFN pricing agreements
    Pfizer chief Albert Bourla told reporters that he does not anticipate any changes to the most‑favored‑nation pricing arrangements that were put in place under the Trump administration, even if the…
    Endpoints · 5d agoRegulatoryNeutral↗ source
  • Novartis ends discovery-stage collaboration with BioArctic amid broader biotech updates
    Novartis announced it is terminating its discovery-stage partnership with Swedish biotech BioArctic. The decision ends joint work that was focused on early‑stage research. BioArctic is best known…
    Endpoints · 6d agoNeutral↗ source
  • Endpoints Announces Second Annual Health Tech Day with Virtual Sessions
    On Thursday, Endpoints will hold its second Health Tech Day, an event that brings together leaders in digital health. Lydia Ramsey Pflanzer, the deputy editor, says she looks forward to traveling…
    Endpoints · 6d agoNeutral↗ source
  • Recon: Merck KGaA to exit CDMO business; Karyopharm to sell itself in bankruptcy
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 6d ago↗ source
  • WuXi Biologics and Fresenius strike major deal for up to 37 biosimilars over the next decade
    WuXi Biologics and German drugmaker Fresenius have agreed to collaborate on the development and manufacturing of up to 37 biosimilar medicines over the next ten years. The agreement is described a…
    Endpoints · 6d agoDealPositive↗ source
  • FDA issues final guidance on potency assurance for cell and gene therapy manufacturers
    The FDA released final guidance today outlining a science- and risk-based Potency Assurance Strategy for cellular and gene therapy (CGT) products. The guidance replaces the agency’s 2011 potency t…
    fda press · 7d agoRegulatoryNeutral↗ source
  • FDA issues final guidance on potency standards for cell and gene therapy developers
    The U.S. Food and Drug Administration released a final guidance on Monday that sets out the expectations for sponsors of cell and gene therapies to demonstrate product potency. The document requir…
    raps · 7d agoRegulatoryNeutral↗ source
  • FDA sets May 1 decision deadline for UniQure’s Huntington’s disease gene therapy after advisory committee meeting
    The U.S. Food and Drug Administration announced that it has set a review date and scheduled an advisory committee meeting for UniQure’s gene therapy aimed at treating Huntington’s disease. The age…
    Endpoints · 7d agoRegulatoryNeutral↗ source
  • FDA places Bright Minds seizure drug BMB-101 on partial hold over mouse toxicity, shares plunge
    The U.S. Food and Drug Administration issued a partial clinical hold on BMB-101, an experimental seizure treatment from Bright Minds Biosciences, after regulators identified toxicity concerns in pr…
    Endpoints · 7d agoRegulatoryNegative↗ source
  • AbbVie signs up to $757M deal with Beijing's Brise Pharma for two preclinical migraine candidates
    AbbVie announced a discovery and commercialization agreement with Brise Pharma, a Beijing-based biotech company. The partnership covers two preclinical migraine programs and is valued at up to $75…
    Endpoints · 6d agoDealNeutral↗ source
  • FDA approves generic lenacapavir for low-income markets; EMA to review Lundbeck's Deanxit over safety concerns
    The U.S. Food and Drug Administration has granted approval for a generic version of lenacapavir, a drug aimed at treating HIV, with the intention of making it available to lower-income countries.…
    raps · 7d agoApprovalNeutral↗ source
  • Karyopharm Therapeutics to merge with Ayrmid as it enters bankruptcy
    Karyopharm Therapeutics, a commercial-stage biotech focused on blood cancers, announced it will pursue a merger with Ayrmid while navigating a bankruptcy process. The move aims to combine the two c…
    Endpoints · 7d agoDealNeutral↗ source
  • CinRx partners with Graviton Bioscience to target ROCK2 in pulmonary arterial hypertension and other cardiovascular diseases
    CinRx announced a collaboration with Graviton Bioscience, led by Sam Waksal, to develop therapies that inhibit the ROCK2 enzyme. The partnership will focus on pulmonary arterial hypertension (PAH)…
    Endpoints · 7d agoDealNeutral↗ source
  • Study finds patient agreement forms match knowledge surveys, urging greater transparency in FDA’s mifepristone REMS
    A randomized controlled trial published in JAMA Internal Medicine examined how well patients understood medication abortion when they signed the FDA’s risk evaluation and mitigation strategy (REMS)…
    raps · 7d agoRegulatoryNeutral↗ source
  • Australian regulator opens consultation on clinical trial data sharing and ICH GCP guidance
    The Therapeutic Goods Administration (TGA) in Australia has launched a public consultation seeking input on how clinical trial information should be shared under existing schemes. The consultation…
    raps · 7d agoRegulatoryNeutral↗ source
  • Brad's Raw Chips recalls kale chips over potential thallium contamination
    Snack Right Super Foods, doing business as Brad's Raw Chips, announced a recall of certain Brad's Plant Based Crunchy Kale (2 oz) and Brad's Veggie Chips Kale (3 oz) products because they may conta…
    fda recalls · 6d agoCRLNegative↗ source
  • Halloween edition of Endpoints Weekly teases Anthropic biotech acquisition and Jake Van Naarden’s deal strategy
    The latest Endpoints Weekly arrives with a Halloween theme, offering a light‑hearted introduction to the issue’s content. Among the topics highlighted is Anthropic’s purchase of a one‑person biote…
    Endpoints · 9d agoNeutral↗ source
  • FDA grants accelerated approval to first plasmid DNA immunotherapy for adult recurrent respiratory papillomatosis
    The U.S. Food and Drug Administration granted accelerated approval for Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) as a treatment for adults with recurrent respiratory pa…
    fda press · 9d agoApprovalPositive↗ source
  • Aspen Neuroscience and Bambusa raise $310M combined in IPOs
    Aspen Neuroscience, a biotech focused on cell therapy for Parkinson's disease, announced it will raise about $141 million through its initial public offering scheduled for Friday. Bambusa, a start…
    Endpoints · 10d agoDealPositive↗ source