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  • Neurosterix raises $105M Series B to advance oral M4 schizophrenia drug and adds former Karuna leaders
    Neurosterix, a spinout from Addex Therapeutics, announced a $105 million Series B financing. The round was led by RTW Investments with participation from GV, Janus Henderson Investors and others. A…
    BioSpace · 2h agoDealPositive↗ source
  • Scientists release detailed basal ganglia cell map, uncover new neuron linked to schizophrenia
    Scientists from a large international collaboration have created the most detailed map of the basal ganglia, a brain region that coordinates movement and emotion. The effort profiled over 25 millio…
    STAT · 2h agoPositive↗ source
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  • FDA faces over 1,000 vacant positions as staffing shortage strains pharma oversight
    The FDA currently has more than a thousand open jobs, reflecting a deep staffing shortfall that began after a large wave of departures last year. The agency lost 1,343 employees at its CBER and CD…
    BioPharma Dive · 3h agoNegative↗ source
  • Pfizer secures up to $1.5 billion from Blackstone to fund berobenatide obesity drug development
    Pfizer announced a financing arrangement with Blackstone Life Sciences that could provide up to $1.5 billion to support the development of berobenatide, an obesity drug acquired from Metsera. The…
    BioSpace · 4h agoDealPositive↗ source
  • Eros Apothecary recalls Candy Power For Man honey supplement after undisclosed tadalafil found
    Eros Apothecary of Indio, California announced a recall of its Candy Power For Man Organic Honey dietary supplement after FDA testing revealed the presence of undeclared tadalafil. Tadalafil is th…
    fda recalls · 2h agoCRLNegative↗ source
  • EnGene reports improved bladder cancer data after May setback
    EnGene, a biotech developing a bladder cancer therapy, released new data that appear more encouraging than the results disclosed in May. The May data had shown limited durability, causing a sharp…
    Endpoints · 2h agoPositive readoutPositive↗ source
  • BioNTech spends $205 million to buy Scholar Rock’s FDA priority-review voucher as J&J scales back in Norway
    BioNTech announced it has purchased an FDA priority review voucher from Scholar Rock for $205 million. The voucher, which can be used to accelerate the regulatory review of a future drug, was origi…
    Endpoints · 2h agoDealPositive↗ source
  • Senate debate looms over Heidi Overton’s potential FDA nomination
    The article raises the question of whether Heidi Overton will be nominated to head the FDA and how the Senate might respond. It notes that a committee chair typically schedules a confirmation vote…
    STAT · 2h agoRegulatoryNeutral↗ source
  • Merck KGaA records €366 million impairment on Lonza CDMO sale as PharmaLogic acquires Lantheus' manufacturing unit
    Merck KGaA disclosed a €366 million ($405.8 million) impairment loss tied to the sale of its contract development and manufacturing organization (CDMO) business to Lonza, according to its third‑qua…
    Endpoints · 3h agoDealNegative↗ source
  • New documents spark fresh concerns over Medicare's AI prior-authorization pilot
    New documents have been released that raise additional questions about Medicare's experiment using artificial intelligence to handle prior-authorization requests. The pilot, which seeks to automat…
    STAT · 3h agoRegulatoryNegative↗ source
  • FDA shelves fast-track drug review program launched in 2025
    The U.S. Food and Drug Administration announced it is suspending the fast-track drug review initiative that was introduced in June 2025 under former commissioner Marty Makary. The program, called…
    STAT · 4h agoRegulatoryNegative↗ source
  • Parker Institute chief urges renewed focus on cancer immunotherapy after mixed results from Revolution Medicines' drug
    Ira Mellman, who leads research at the Parker Institute for Cancer Immunotherapy, said on Sept. 16, 2026 that he felt disappointment and frustration as the industry celebrated Revolution Medicines'…
    Endpoints · 4h agoNegative↗ source
  • BMS to consolidate R&D under single leader as chief research officer exits
    Bristol Myers Squibb announced a reorganization of its research and development unit, merging early research and discovery with drug development under a single leader. Chief Research Officer Rober…
    BioSpace · 4h agoNeutral↗ source
  • Experts say predictive analytics and distributed manufacturing could curb drug shortages
    BioSpace Insights hosted a podcast episode featuring Christina Smolke, co-founder and CEO of Antheia, and Kyle Pudenz, senior vice president of data and AI product at Cencora. The conversation focu…
    BioSpace · 6h agoPositive↗ source
  • American Cancer Society recommends routine PSA screening for men 50-69, strengthens guidance for high-risk groups
    The American Cancer Society (ACS) has updated its prostate-cancer screening guidelines, now advising men at average risk aged 50 to 69 to have a PSA blood test every two years. This replaces the 20…
    STAT · 6h agoRegulatoryPositive↗ source
  • Alnylam faces slowdown in Amvuttra sales, putting its growth ambitions at risk
    Alnylam’s market narrative has long hinged on the performance of its cardiomyopathy drug Amvuttra. The company once hoped the therapy could lift its valuation toward the $100 billion range. Recent…
    STAT · 7h agoNegative↗ source
  • Blackstone pledges up to $1.5 billion to fund Pfizer's obesity drug berobenatide development
    Blackstone Life Sciences has agreed to provide up to $1.5 billion to support the research and development of Pfizer's obesity candidate, berobenatide, which originated from the former Metsera progr…
    Endpoints · 7h agoDealPositive↗ source
  • New governors should prioritize health hires, vaccination data, and a focused agenda
    Mandy Cohen and Ellen Montz, former state health leaders, write an opinion piece aimed at the 21 governors who will assume office on Jan. 1. They draw on their experience at the CDC, state health d…
    STAT · 9h agoPositive↗ 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 · 12h agoLayoffsNegative↗ source
  • Bristol Myers appoints Cristian Massacesi as head of R&D as Robert Plenge exits
    Bristol Myers Squibb announced a reorganization of its research and development organization, merging the research and development units under a single leader. Cristian Massacesi, currently chief…
    BioPharma Dive · 2h agoNeutral↗ 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 · 2h agoRegulatoryNeutral↗ source
  • Bristol Myers shifts R&D leadership to chief medical officer Cristian Massacesi as research head Robert Plenge departs
    Bristol Myers Squibb announced a reorganization of its research and development structure. The company said chief medical officer and head of development Cristian Massacesi will assume the duties…
    Endpoints · 6h agoNeutral↗ 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 · 7h agoPositive readoutNeutral↗ 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 · 12h 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 · 1h agoRegulatoryNeutral↗ source