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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
  • Lonza to acquire five Merck KGaA US facilities, more than doubling its US footprint
    Lonza, a Swiss contract development and manufacturing organization, announced it will purchase five U.S. manufacturing sites from Merck KGaA. The transaction is valued in the low‑ to mid‑triple‑di…
    BioSpace · 6d agoDealPositive↗ source
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  • Novartis ends $772M BioArctic brain-delivery partnership
    Novartis has terminated its neurodegeneration alliance with BioArctic, a partnership that was valued at more than $772 million. The collaboration focused on using BioArctic’s BrainTransporter techn…
    BioSpace · 6d agoDealNegative↗ source
  • Pfizer reports flat Q3 revenue as non-COVID sales rise 7% and acquired products grow 32%
    Pfizer posted third‑quarter revenue of $16.6 billion, essentially unchanged from $16.7 billion a year earlier. The flat top line reflects declines in its legacy Prevnar vaccine and COVID‑related pr…
    BioSpace · 6d agoEarningsNeutral↗ 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 · 7d agoDealNeutral↗ source
  • Pfizer drops phase 2 pulmonary arterial hypertension candidate amid pipeline cut
    Pfizer has discontinued its phase 2 pulmonary arterial hypertension (PAH) program, PF-07868489, citing business reasons rather than safety or efficacy concerns. The drug, which targets BMP9 inhibi…
    Fierce Biotech · 7d agoNegative↗ source
  • AbbVie commits £120 million to new Oxford R&D hub, boosting UK life‑science footprint
    AbbVie announced a £120 million ($160 million) investment to expand its research footprint in the United Kingdom. The company will open a new 12,000‑square‑foot R&D facility in Oxford, joining its…
    Fierce Biotech · 7d agoDealPositive↗ source
  • Novartis ends $800M neuroscience partnership with BioArctic after 14 months
    Novartis signed an $800 million neuroscience partnership with BioArctic in August 2025, providing $30 million upfront to merge BioArctic’s BrainTransporter technology with a Novartis antibody targe…
    Fierce Biotech · 7d agoDealNegative↗ source
  • Abbott reports 30‑day success in Tectonic trial of SonicForce coronary IVL system
    Abbott announced that its investigational SonicForce Coronary IVL system achieved positive 30‑day outcomes in the Tectonic trial involving patients with severely calcified coronary artery disease.…
    Fierce Biotech · 7d agoPositive readoutPositive↗ source
  • 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 · 7d 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 · 7d agoRegulatoryNeutral↗ source
  • Advanced analytics enable up to 12% cut in control animal use while keeping study rigor
    The control group is a cornerstone of nonclinical safety studies, providing the baseline needed to separate a drug’s effects from normal biological variation. Researchers are now applying virtual…
    Fierce Biotech · 7d agoPositive↗ source
  • AbbVie halts development of livmoniplimab after deeming benefit limited
    AbbVie announced it is discontinuing the phase 2 development of its monoclonal antibody livmoniplimab (ABBV-151) after concluding the drug is unlikely to outperform existing therapies. The drug wa…
    Fierce Biotech · 7d agoNegative↗ 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 · 7d 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 · 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
  • GE HealthCare launches Allia Celeo ceiling-mounted AI image guidance system at TCT 2026
    GE HealthCare introduced a new imaging product called Allia Celeo. The system is mounted on the ceiling and uses artificial intelligence to guide image acquisition during procedures. The debut…
    Fierce Biotech · 7d agoPositive↗ 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 · 7d ago↗ source
  • FDA places uniQure’s Huntington’s gene therapy in priority review, targeting May 2027 approval
    The U.S. Food and Drug Administration has accepted uniQure’s filing for its Huntington’s disease gene therapy and placed the product under priority review, a step that could accelerate a decision b…
    Fierce Biotech · 7d agoRegulatoryPositive↗ source
  • FDA sets May 1 decision date for uniQure's Huntington's disease gene therapy after year-long regulatory saga
    The U.S. Food and Drug Administration has accepted uniQure's biologics license application for its Huntington's disease gene therapy and placed it on the priority review track, with a May 1 target…
    BioSpace · 7d agoRegulatoryPositive↗ 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
  • Cell and gene therapy funding climbs to $2.2 billion in Q3 despite safety setbacks in CAR-T trials
    Sail Biomedicine’s $925 million agreement with Johnson & Johnson helped lift venture capital money into the cell and gene therapy (CGT) space during the third quarter. CGT attracted $2.2 billion a…
    BioSpace · 7d agoDealNeutral↗ source
  • FDA policy allowing compounding of unapproved peptides raises safety and development concerns
    The Department of Health and Human Services recently approved the compounding of six peptide products that have not received FDA approval. This move expands the list of bulk substances that traditi…
    BioSpace · 7d agoRegulatoryNegative↗ source