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1,206 stories matching this filter · ← front page

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  • Pfizer targets Europe first for upcoming Lyme disease vaccine amid rising US cases
    Pfizer is planning to launch its Lyme disease vaccine in Europe first, leveraging its existing tick-borne encephalitis franchise in the region. The vaccine, developed with French partner Valneva,…
    BioSpace · 5d agoRegulatoryPositive↗ source
  • China targets five $1 billion blockbuster drugs by 2030, two already achieved
    China's latest five-year plan aims to develop five domestically created drugs that each generate over $1 billion in global sales by 2030. According to industry analysts, two drugs have already sur…
    BioSpace · 6d agoPositive↗ source
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  • Boehringer bets big on China, offering $7B biobucks for Sino cancer programs
    Boehringer Ingelheim is building up its China strategy, inking a deal to develop new cancer treatments with Sino Biopharmaceutical just weeks after opening an R&D facility in Shanghai.
    BioSpace · 5d agoDealNeutral↗ source
  • Amgen launches autoinjector study for GLP-1 candidate MariTide as Phase 3 readouts loom
    Amgen has begun a study of an autoinjector formulation of its GLP-1 drug candidate MariTide, as the company prepares for pivotal Phase 3 data expected next year. The candidate is marketed as havin…
    BioSpace · 5d agoNeutral↗ source
  • Novo and Pfizer say MFN pricing agreements remain unchanged despite Democratic gains in Congress
    On their third‑quarter earnings calls, the CEOs of Novo Nordisk and Pfizer said the Most Favored Nation drug‑pricing contracts they signed under the previous administration are still in effect and…
    BioSpace · 5d agoRegulatoryNeutral↗ source
  • Sanofi drops Nurix STAT6 degrader program amid molecule-specific concerns
    Sanofi has halted development of an early‑stage STAT6 degrader program that it licensed from Nurix Therapeutics. The decision was announced after the asset entered Phase 1 trials for type 2 inflamm…
    BioSpace · 5d agoNeutral↗ source
  • BioSpace launches dashboard to track performance of U.S. biotech IPOs in 2026
    BioSpace introduced a new IPO dashboard that monitors U.S. biotech companies that went public in 2026. The tool will be refreshed weekly with the latest closing prices and will add any newly liste…
    BioSpace · 5d agoNeutral↗ source
  • Flagship partner Louisa Helms credits high-school librarian for sparking biotech career
    Louisa Helms, a BioSpace 40 Under 40 honoree and partner at Flagship Pioneering, reflects on a unique path into biotech. In high school she was mentored by librarian Tammy Carabello, who turned th…
    BioSpace · 5d agoPositive↗ source
  • AbbVie bets up to $1.47B for Nxera’s discarded IBD program
    AbbVie’s $100 million upfront cash payment will purchase global rights to Nxera’s deprioritized oral small molecule, which has already completed Phase 1 testing.
    BioSpace · 5d ago↗ source
  • Neurocrine launches new safety study after another death linked to Prader-Willi drug Vykat
    Neurocrine Biosciences announced it will start a new study to evaluate dosing and safety of its rare disease drug Vykat in patients with Prader-Willi syndrome who have complex health issues. The m…
    BioSpace · 6d agoRegulatoryNegative↗ source
  • Medicare Part D premiums expected to rise 50% on average in 2027, KFF warns seniors to compare plans
    KFF analysis shows average monthly premiums for Medicare Part D standalone plans will jump from $34 to $51 in 2027, a 50% increase if seniors stay in their current plans. Premiums vary widely acro…
    BioPharma Dive · 6d agoRegulatoryNegative↗ source
  • Pfizer partners with Sciwind to launch GLP-1 obesity drug Ecnoglutide in China
    Pfizer is entering China's obesity market with a new GLP-1 drug, Ecnoglutide, in partnership with Sciwind Biosciences. The New York-based company secured mainland China licensing rights to the inj…
    BioSpace · 6d agoDealPositive↗ 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
  • 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
  • UniQure slated for FDA decision by May 1 as analysts see potential for first Huntington’s disease therapy
    UniQure said the Food and Drug Administration has set a decision date for its Huntington's disease gene therapy and is likely to hold an advisory committee meeting. The agency indicated a faster‑th…
    BioPharma Dive · 6d agoRegulatoryNeutral↗ source
  • Vertex, ahead of FDA decision, calms fears surrounding kidney drug
    On a conference call, executives expressed conviction in the coming launch of an IgA nephropathy medicine viewed by Wall Street investors as important to Vertex’s future.
    BioPharma Dive · 6d agoEarningsNeutral↗ 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
  • 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
  • Karyopharm files for Chapter 11 and plans auction with Gamida Cell parent Ayrmid as lead bidder
    Karyopharm Therapeutics, a cash-strapped cancer drugmaker, announced a Chapter 11 filing on Monday and will conduct a court-supervised auction of the company. Ayrmid, the parent of cell-therapy co…
    BioPharma Dive · 7d agoDealNegative↗ source
  • AstraZeneca outlines restructuring as earnings show cost cuts, while Alnylam slides and Regeneron posts record quarter
    AstraZeneca said it will redeploy resources through a new restructuring program aimed at cutting costs while staying on track to hit its long‑term revenue goal of $80 billion by 2030. The company h…
    BioPharma Dive · 7d agoEarningsNeutral↗ source
  • FDA issues draft guidance to streamline approval of personalized gene therapies
    The FDA released a draft guidance that outlines an "adapted pathway" for regulating gene‑edited medicines. The new framework is intended to speed the development and approval of personalized gene t…
    BioSpace · 7d agoRegulatoryPositive↗ source
  • Karyopharm files for Chapter 11 bankruptcy as it pursues merger with Ayrmid
    Karyopharm Therapeutics has filed for Chapter 11 bankruptcy while seeking a merger with U.K. biotech Ayrmid. The court‑supervised process is intended to provide a financial lifeline for the company…
    BioSpace · 7d agoNegative↗ source
  • Sun Pharma halts eye-care drug production in India after regulator cited quality failures
    Sun Pharma has stopped manufacturing eye-care medicines at its Assam facility after Indian regulators identified failures in the company's quality management system. The company previously recalle…
    BioSpace · 7d agoRegulatoryNegative↗ source