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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 · 6d 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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  • 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 · 6d 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
  • 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 · 7d 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 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 · 7d agoDealNeutral↗ 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
  • 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 · 7d 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 · 10d 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
  • Sanofi plans to pursue higher European drug prices rather than delay product launches under Trump policy
    Sanofi indicated it may seek higher drug prices in Europe as part of a deal related to President Trump's pricing policies. Unlike other major European pharma companies that have warned the policie…
    Endpoints · 10d agoNeutral↗ source
  • Gilead places CAR-T program on partial hold after ICANS cases; Agios delays PDUFA submission
    Gilead announced a partial clinical hold on its CAR-T therapy after several patients experienced immune effector cell-associated neurotoxicity syndrome (ICANS). The hold will pause enrollment and…
    Endpoints · 10d agoRegulatoryNegative↗ source
  • AstraZeneca hints restructuring may trim R&D budget and move trials to emerging markets
    AstraZeneca's chief executive Pascal Soriot told journalists that the company's new restructuring program could lead to cost reductions in research and development and may see some clinical trials…
    Endpoints · 10d agoNegative↗ source
  • Sanofi says no major restructuring despite upcoming Dupixent patent expiration
    Sanofi's new chief executive, Belén Garijo, said after six months in charge that the company will not embark on a major overhaul of its business or research pipeline. The comment was made as the b…
    Endpoints · 10d agoNeutral↗ source
  • AstraZeneca launches $1.5 billion annual cost-saving plan to offset late-stage trial setbacks
    AstraZeneca announced a new cost‑saving initiative targeting $1.5 billion of annual expenses. The move follows a series of late‑stage clinical trial failures that have pressured the company's pipe…
    Endpoints · 10d agoNegative↗ source
  • Setara Biosciences raises $90 million to advance rare-disease pipeline after Actio spin-out
    Actio Biosciences shipped its precision epilepsy drug to Jazz Pharmaceuticals and then separated the rest of its genetics-driven pipeline into a new company called Setara Biosciences. Setara has s…
    Endpoints · 10d agoDealPositive↗ source
  • Anthropic appoints former Genentech scientist Nathan Frey to lead drug discovery after acquiring Coefficient Bio
    Anthropic, the AI company, recently bought biotech startup Coefficient Bio. Following the acquisition, the startup’s founder Nathan Frey, who previously worked at Genentech on machine‑learning proj…
    Endpoints · 10d agoNeutral↗ source
  • Former Be Bio chief Joanne Smith-Farrell appointed CEO of Orbis Medicines as Enanta CEO Jay Luly announces retirement
    Former Be Bio Pharmaceuticals CEO Joanne Smith-Farrell has joined Orbis Medicines as its new chief executive. Orbis, a startup backed by Eli Lilly and Novo Nordisk, focuses on developing oral macr…
    Endpoints · 10d agoNeutral↗ source