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  • Swiss biotech Windward Bio raises $175 million in IPO to fund lung-drug development and test Tezspire competitor
    Windward Bio, a Swiss immune‑drug developer, completed a $175 million initial public offering, selling about 10.3 million shares at $17 each. The company began trading on the exchange under the tic…
    BioPharma Dive · 13h agoDealPositive↗ source
  • ObesityWeek 2026 to showcase amylin pathway and emerging weight-loss mechanisms
    ObesityWeek 2026 starts Saturday in Washington, DC, gathering weight-loss experts and biopharma companies with metabolic assets. The meeting will highlight the amylin pathway and other emerging me…
    BioSpace · 2h agoNeutral↗ source
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  • This week in charts: Brain drugs are back on venture capitalists’ minds
    Five neurology-focused startups have together raised around $450 million in the last few weeks. Elsewhere, investors had a muted response to the latest cell therapy research.
    BioPharma Dive · 1h ago↗ source
  • Regeneron’s POTS antibody curbs heart rate spikes, teeing up Phase 3 trial
    Regeneron’s mid-stage success in postural orthostatic tachycardia syndrome has the company gearing up to launch a Phase 3 study in the first half of 2027.
    BioSpace · 1h ago↗ source
  • Eli Lilly’s Mounjaro and Merck’s oral PCSK9 inhibitor win FDA nod amid string of cardiovascular trial setbacks
    The cardiovascular drug development landscape entered the American Heart Association’s Scientific Sessions with a mix of optimism and disappointment. Recent months have seen several late‑stage tria…
    BioSpace · 20h agoRegulatoryNeutral↗ source
  • 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 · 23h agoDealPositive↗ source
  • 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 · 1d 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 · 1d agoDealPositive↗ 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 · 1d 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 · 1d 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 · 1d agoLayoffsNegative↗ 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
  • 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 · 23h 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 · 23h agoRegulatoryNeutral↗ 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
  • 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 · 17h 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
  • 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
  • Blackstone bets $1.5B on Pfizer’s obesity drug
    The deal will support a sprawling Phase 3 program for a monthly GLP-1 shot Pfizer acquired by winning a bidding war for the drug’s previous owner, Metsera.
    BioPharma Dive · 22h 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
  • Capricor boosts manufacturing capacity as FDA decision on DMD cell therapy looms
    Capricor Therapeutics, a biotech developing a cell therapy for Duchenne muscular dystrophy, is preparing for an FDA decision expected by late November. The company’s third-quarter operating expens…
    BioSpace · 2d agoRegulatoryNeutral↗ source