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  • Anthropic outlines biopharma strategy ahead of potential record-size IPO
    Anthropic, the AI startup that recently filed paperwork for what could become the largest initial public offering in business history, used its AI Day event to detail its biopharma ambitions. The…
    Endpoints · 15d agoNeutral↗ source
  • Flagship Pioneering merges three portfolio companies to boost AI drug discovery
    Flagship Pioneering, a biotech incubator based in Cambridge, Massachusetts, announced it is merging three of its portfolio companies into a single organization. The consolidation includes a compan…
    Endpoints · 15d agoDealPositive↗ source
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  • Australia emerges as a hub for early-stage clinical trials thanks to speed, clear regulations and tax incentives
    A recent episode of BioSpace’s Denatured podcast featured Jerome Barley of Avion Medical and Ryan Klein of Resolian discussing Australia’s growing appeal for early-stage clinical development. The…
    BioSpace · 15d agoPositive↗ source
  • Eli Lilly leans on cash-pay model to grow obesity drug sales in US and overseas
    Eli Lilly has observed that patients in the United States are prepared to pay several hundred dollars each month for treatments targeting obesity. The company has focused on a cash-pay approach, s…
    Endpoints · 14d agoNeutral↗ source
  • BMS shelves Prothena-partnered neuro drug after Phase 1 review, but raises full-year revenue outlook on 7% Q3 sales growth
    Bristol Myers Squibb announced it will not move forward with the neurodegeneration candidate BMS-986495 (PRX019), a monoclonal antibody licensed from Prothena. The decision follows a review of Phas…
    BioSpace · 14d agoNeutral↗ source
  • Dren Bio secures $350 million to advance blood-cancer therapy toward 2027 launch
    Dren Bio, a California biotech firm, announced it has closed a financing round that raised $350 million. The funding will be directed toward developing its lead blood‑cancer drug, with the company…
    Endpoints · 15d agoDealPositive↗ source
  • Medline orders removal of all brand beds and accessories over fire and asphyxiation hazards
    Medline has issued an urgent field safety notice indicating that all of its branded hospital beds and related components must be removed or corrected because of identified safety risks. The FDA’s…
    fda medwatch · 15d agoRegulatoryNegative↗ source
  • Biopharma job postings in New York surge 109% year over year, eight firms hiring
    BioSpace data shows that biopharma job postings in New York have surged, rising 109% from Oct 1 2025 to Oct 26 2026, with month‑over‑month gains of 32% in August‑September and 19% in September‑Octo…
    BioSpace · 15d agoPositive↗ source
  • Lilly can’t stop, won’t stop as revenue climbs 39% thanks to GLP-1 bestsellers
    Eli Lilly’s shares rose 4% in early morning trading after reporting revenue of $24.4 billion, well past consensus estimates.
    BioSpace · 15d agoEarningsNeutral↗ source
  • HHS adopts enforcement discretion allowing compounding pharmacies to produce six unapproved peptides
    HHS announced an "enforcement discretion" policy that permits compounding pharmacies to make six peptide products that have not received FDA approval. The list includes BPC-157 and TB-500, which a…
    BioSpace · 15d agoRegulatoryNeutral↗ source
  • SLR Food Distribution recalls Wise Wife ground cinnamon over possible lead contamination
    SLR Food Distribution Inc., based in Hicksville, New York, announced a voluntary recall of its Wise Wife brand ground cinnamon. The recall was issued because the product may be contaminated with e…
    fda recalls · 14d agoRegulatoryNegative↗ source
  • Genmab’s bispecific antibody petosemtamab plus Keytruda cuts death risk by half in Phase 3 head‑and‑neck cancer trial
    Genmab announced that its bispecific antibody petosemtamab, combined with Merck’s Keytruda, met both co‑primary endpoints in a Phase 3 trial for head‑and‑neck squamous cell carcinoma. The LiGeR‑HN…
    BioSpace · 15d agoPositive readoutPositive↗ source
  • Big pharma holds $188 bn for M&A, J&J seen as most likely buyer, analysis shows
    The latest Leerink Partners analysis finds that the largest pharmaceutical companies collectively have about $188 billion in cash available for mergers and acquisitions. All but one of the firms su…
    BioSpace · 16d agoDealPositive↗ source
  • FDA issues draft guidance to streamline approval of personalized gene therapies and expands CMS access model
    The Food and Drug Administration released a draft guidance that lets a single biologics license application cover multiple variants of a gene‑therapy product. The guidance introduces an Individuali…
    BioSpace · 16d agoRegulatoryPositive↗ source
  • Astellas signs up to $1.34 billion option deal for Audax's DAX-044 immuno-oncology candidate
    Astellas Pharma announced it will pay up to $1.34 billion for an exclusive option to license Audax Biosciences' investigational antibody-cytokine fusion, DAX-044. The agreement includes an undiscl…
    BioSpace · 16d agoDealPositive↗ source
  • FDA outlines pathway for approval of personalized gene-editing therapies
    The U.S. Food and Drug Administration released a set of recommendations describing how developers can pursue regulatory approval for gene-editing treatments that are customized to a single patient’…
    Endpoints · 15d agoRegulatoryNeutral↗ source
  • AstraZeneca’s heart drug Wainua fails late-stage trial, raising 2027 outlook concerns
    AstraZeneca announced that its experimental heart disease therapy, Wainua, did not meet primary endpoints in a Phase III trial conducted in July. The failure is a setback for the company, whose pi…
    Endpoints · 15d agoNegative readoutNegative↗ source
  • Biogen sees continued revenue growth and pipeline readouts, M&A not essential, CEO says
    Biogen reported third‑quarter earnings, marking a third straight quarter of revenue growth driven by its marketed products. The increase stemmed from higher sales of the Alzheimer’s therapy Leqemb…
    BioSpace · 15d agoEarningsPositive↗ source
  • Pfizer shuts India cancer drug plant for up to two years, worsening drug shortages
    Pfizer has temporarily closed a manufacturing site in India that produces several cancer medicines. The company says the facility will remain idle for as long as two years while it addresses the i…
    Endpoints · 16d agoRegulatoryNegative↗ source
  • Biogen posts third consecutive quarter of revenue growth, driven by Leqembi, Spinraza and Apellis products
    Biogen reported $2.8 billion in revenue for the third quarter, marking its third straight period of top‑line growth. The company credited its growth portfolio, led by the Alzheimer’s therapy Leqem…
    BioSpace · 16d agoEarningsPositive↗ source
  • Five newly approved drugs achieve strong launches by offering superior efficacy, pricing and access
    Over the past year several newly approved therapies have entered the market with sales and uptake that far exceed analyst expectations, driven by strong clinical data, reasonable pricing and easy p…
    BioSpace · 16d agoPositive↗ source
  • Biotech firms must adopt global regulatory strategies to commercialize drugs independently
    Biotech developers are increasingly able to fund the pursuit of regulatory approval and commercial launch on their own, rather than selling their assets early. This new option is driven by a reboun…
    BioSpace · 16d agoRegulatoryPositive↗ source
  • Formation Bio raises $600 million fund to expand AI-driven drug licensing and testing model
    Formation Bio, an AI-focused biotech that builds value by acquiring external drug assets, developing them and then transferring them to partners, announced a new financing round. The company secur…
    Endpoints · 15d agoDealPositive↗ source
  • Analysts Question Biogen's Lupus Drug Litifilimab Ahead of Key Phase 3 Readouts
    Analysts pressed Biogen CEO Chris Viehbacher during a recent call, focusing on the company's late‑stage pipeline. The discussion centered on litifilimab, Biogen’s experimental lupus therapy, with…
    Endpoints · 15d agoNeutral↗ source
  • Chinese biotech BioGeometry secures over $100 million Series A for AI-driven protein design
    BioGeometry, a four-year-old biotech startup based in Beijing, announced it has closed a Series A financing round of more than $100 million. The capital will be used to expand its artificial-intel…
    Endpoints · 16d agoDealPositive↗ source