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3,762 stories matching this filter · ← front page

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  • BMS consolidates R&D under chief medical officer Cristian Massacesi as chief research officer Robert Plenge exits
    Bristol Myers Squibb announced that starting Jan. 1, its chief medical officer and head of development, Cristian Massacesi, will lead a newly combined research and development unit, merging previou…
    Fierce Biotech · 1d agoNeutral↗ source
  • Biopharma layoffs rise YoY in October but overall trend points down for 2026
    October marked the first time this year that both the number of biotech and pharma firms announcing workforce cuts and the total employees affected rose compared with 2025. Three additional employ…
    BioSpace · 1d agoLayoffsNegative↗ source
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  • Neurosterix secures $105M Series B to launch phase 2 schizophrenia trial
    Addex Therapeutics' spinout Neurosterix announced a $105 million Series B financing to fund its upcoming phase 2 trial of NTX-253 for schizophrenia. The round was led by a syndicate of leading lif…
    Fierce Biotech · 1d agoDealPositive↗ source
  • FDA pauses voucher program as Eli Lilly's GLP-1 weight-loss drug cleared in China; experts see AI aid for device regulation
    The U.S. Food and Drug Administration announced it is shelving the commissioner's voucher program, effectively pausing the incentive that speeds up review of certain products. Eli Lilly secured ap…
    raps · 1d agoRegulatoryNeutral↗ source
  • EMA seeks industry input on draft guideline for biomarker-guided therapy approvals
    The European Medicines Agency has published a draft guideline that details the information required for approving medicines that use biomarkers to select patients. The agency is opening a public c…
    raps · 1d agoRegulatoryNeutral↗ source
  • FDA asks industry for feedback on improving patient-level real-world data submissions
    The FDA announced a request for comments on ways to address challenges associated with submitting patient-level real-world data and evidence in drug and biologic applications. The agency is seekin…
    raps · 1d agoRegulatoryNeutral↗ source
  • FDA shelves Commissioner’s National Priority Voucher program ahead of Heidi Overton confirmation vote
    The Food and Drug Administration has halted the Commissioner’s National Priority Voucher (CNPV) program as the Senate prepares to vote on Heidi Overton’s nomination as the agency’s next commissione…
    BioSpace · 22h agoRegulatoryNeutral↗ source
  • Biogen prepares to unveil results of litifilimab Phase 3 TOPAZ-1 and TOPAZ-2 lupus trials in December
    Biogen is set to release the readout from two pivotal Phase 3 studies, TOPAZ-1 and TOPAZ-2, evaluating its lupus drug litifilimab. The data are expected in the first half of December and will be th…
    STAT · 1d agoPositive readoutNeutral↗ source
  • FDA suspends National Priority Voucher pilot and pauses release of complete response letters
    The Food and Drug Administration has quietly ended the National Priority Voucher pilot, a program that was designed to speed the review of certain drug candidates. In addition, the agency appears…
    Fierce Biotech · 1d agoRegulatoryNeutral↗ source
  • Vor Bio pays RemeGen $10 million for rights to long-acting autoimmune drug candidate RC298
    Vor Bio announced a licensing agreement with RemeGen, paying $10 million upfront in cash and issuing warrants valued at about $46 million for rights to RC298 outside Greater China. RC298 is a long…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Biopharma job postings rise 31% YoY in Q3 while layoffs plunge 90%
    The third‑quarter 2026 job market report shows a strong rebound in biopharma hiring. Live job listings on BioSpace were up 31% compared with the same period last year, marking the biggest year‑over…
    BioSpace · 1d agoLayoffsPositive↗ source
  • STAT+: Blackstone backs Pfizer’s bet on monthly obesity treatment
    Pfizer spent up to $10 billion to buy Metsera last year. Now, it’s bringing in private equity behemoth Blackstone to help pay for the deal.
    STAT · 22h agoRegulatoryNeutral↗ source
  • Newly elected doctors and scientists aim to rebuild public trust in science after midterm wins
    Last week doctors and scientists across the United States were elected to office, with the help of the group 314 Action. The organization, which supports Democratic candidates with scientific backg…
    STAT · 1d agoNeutral↗ source
  • Kyverna pauses development of next-gen autoimmune CAR-T KYV-102 to focus on neurologic miv-cel program
    Kyverna Therapeutics announced it is halting work on its next-generation CD19 CAR-T candidate KYV-102, which had been positioned as a follow-up to its lead autoimmune CAR-T miv-cel. KYV-102 was de…
    Fierce Biotech · 1d agoNegative↗ source
  • Webinar Highlights Benefits of Cryopreserved Cells for Faster, Consistent CAR-T Manufacturing
    The webinar, scheduled for November 12, 2026, discusses how the timing of immune-cell isolation and the use of cryopreserved starting materials affect cell-therapy manufacturing. It focuses on both…
    BioSpace · 16h agoNeutral↗ source
  • Biopharma hiring surge in New Jersey as BioSpace lists ~300 open positions across 10 companies
    BioSpace job postings in New Jersey increased year over year in October 2026, with around 300 positions now listed. While postings fell 25% from September to October, overall year-over-year number…
    BioSpace · 1d agoNeutral↗ source
  • Specialized AI tools could streamline medical device regulatory work, experts say, but need expert oversight
    At a recent RAPS AI in Regulatory conference in Barcelona, a panel of experts discussed the role of specialized artificial intelligence in meeting regulatory requirements for medical devices. They…
    raps · 1d agoRegulatoryNeutral↗ source
  • ARPA-H bets $4.9 million on ibogaine for PTSD treatment in veterans
    The U.S. department of health and human services announced a $4.9 million bet to advance the development of ibogaine for post-traumatic stress disorder (PTSD).
    Fierce Biotech · 1d agoNeutral↗ source
  • Study finds Black Americans share many concerns with MAHA despite low overall support
    Jerel Ezell, an epidemiologist at the University of Chicago Medical Center, writes an opinion piece examining the complex relationship between the MAHA movement and Black Americans. A 2025 poll by…
    STAT · 1d agoNeutral↗ source
  • Pfizer taps Blackstone for up to $1.5B to pave path to GLP-1's obesity launch
    Pfizer has secured up to $1.5 billion from Blackstone Life Sciences to fund development of its monthly GLP-1 receptor agonist.
    Fierce Biotech · 1d agoNeutral↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 23h agoLayoffsNegative↗ source
  • Experts update prostate cancer screening guidelines for men
    Are you an American man between 50 and 69? You might want to get checked for prostate cancer, ACS says in reversal of previous guidelines.
    STAT · 1d ago↗ source
  • Novartis' Zolgensma linked to tumors as FDA probes gene therapy and orders GLP-1 eye risk warnings
    Novartis confirmed that nine patients who received its Zolgensma gene therapy for spinal muscular atrophy have developed tumors, prompting the FDA to open an investigation into the approved treatme…
    BioSpace · 2d agoRegulatoryNegative↗ source
  • China’s five-year plan positions it to become a global leader in innovative biopharma by 2030
    China’s latest five‑year plan sets an ambitious target to turn the country into a major source of innovative medicines for the world market. Experts cited by BioSpace say the goal is within reach,…
    BioSpace · 2d agoRegulatoryPositive↗ source
  • Abbott nabs FDA approval, CE Mark for implantable cardioverter-defibrillator lead
    Abbott has received both FDA and CE Mark approval for its UltiSynq defibrillation lead tech, which is designed to deliver both conduction system pacing and defibrillation therapy.
    Fierce Biotech · 2d agoApprovalPositive↗ source