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  • Eli Lilly lifts guidance by $10 billion as GLP‑1 sales outpace expectations
    Eli Lilly said its latest financial guidance is $10 billion higher than previously forecast, driven by strong sales of its GLP‑1 medicines. The company’s commercial performance has repeatedly excee…
    BioSpace · 11d agoEarningsPositive↗ source
  • Voters demand action on soaring health-care costs, boosting support for Medicare for All
    Recent polls show Americans increasingly worried about the rising cost of health care, with many saying it is their top financial concern. Voter anger is directed at politicians, who are seen as f…
    STAT · 11d agoNegative↗ source
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  • Dren Bio raises $350 million to advance rare blood cancer antibody
    Dren Bio, a California biotech, announced a $350 million financing round to fund late‑stage development and commercial preparation of its lead therapy, a CD94‑targeting monoclonal antibody known as…
    BioSpace · 11d agoDealPositive↗ source
  • Biopharma manufacturing cuts slated to affect over 4,000 workers, with BioNTech leading layoffs
    Companies investing billions to reshore drug production are trimming staff at manufacturing sites, with ten biotech and pharma firms planning cuts that could affect more than 4,000 employees. BioN…
    BioSpace · 12d agoLayoffsNegative↗ source
  • Federal rule forces PBMs to disclose fees and rebates to employers
    The Trump administration finalized a regulation that will require pharmacy benefit managers (PBMs) to reveal the various fees and compensation they receive from drugmakers, consultants and other pa…
    STAT · 11d agoRegulatoryPositive↗ source
  • Ono Pharma halts ONO-1110 development for depression and anxiety after five Phase 2 failures, continues pain studies
    Ono Pharma announced that its endocannabinoid modulator ONO-1110 failed to demonstrate efficacy in five Phase 2 trials, prompting the company to stop development for depression and social anxiety.…
    BioSpace · 11d agoNegative readoutNegative↗ source
  • Vertex kidney disease drug faces infection risk scrutiny ahead of FDA decision
    Vertex's kidney disease therapy is expected to receive FDA approval, with the agency's decision scheduled for Nov 30. A previously undisclosed pause rule has drawn attention, raising concerns abou…
    STAT · 11d agoRegulatoryNeutral↗ source
  • New tumor atlas reveals why colorectal cancer is more aggressive in younger patients
    Researchers have created a new atlas that catalogs 189 colorectal tumor samples from patients aged in their 20s to 90s, aiming to clarify why cancers that arise early are harder to treat. The coll…
    STAT · 11d agoPositive↗ source
  • 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 · 11d agoPositive↗ source
  • FDA approves Stada's Lucentis biosimilar; Lilly claims its triple-G candidate outperforms Ozempic in diabetes
    The U.S. Food and Drug Administration has granted approval for Stada's biosimilar version of Lucentis, expanding treatment options for eye diseases. Lilly announced that its experimental "triple‑G…
    raps · 12d agoApprovalPositive↗ source
  • EMA and African regulator issue joint guidance to accelerate Ebola vaccine trials
    The European Medicines Agency and its African counterpart have released a joint position paper aimed at facilitating Ebola vaccine research. The guidance is intended to help launch clinical trials…
    raps · 12d agoRegulatoryPositive↗ 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 · 11d agoNeutral↗ source
  • Treasury's Proposed China Investment Rule Sparks Debate Over Licensing Exemptions
    The U.S. Treasury Department recently proposed a rule that would limit American investment in Chinese biotechnology companies, prompting immediate discussion among industry stakeholders. Commentat…
    STAT · 11d agoRegulatoryNeutral↗ source
  • HHS issues interim policy allowing compounding of six unapproved peptides under set conditions
    HHS announced an interim policy that will not take enforcement action against state-licensed pharmacies, federal facilities, or licensed physicians that compound six unapproved peptide bulk drug su…
    raps · 12d agoRegulatoryNeutral↗ source
  • FDA issues revised draft guidance for drug-device combination product performance
    The U.S. Food and Drug Administration has released a revised draft guidance aimed at helping sponsors of drug-device combination products develop essential drug delivery device performance characte…
    raps · 12d agoRegulatoryNeutral↗ source
  • Michigan Senate candidate El-Sayed rebuts RFK Jr. and highlights FDA's new enforcement discretion on peptide drugs
    Abdul El-Sayed, the Democratic Senate hopeful in Michigan, pushed back against recent statements made by RFK Jr., defending his own health-care positions and emphasizing his background as an immigr…
    STAT · 11d agoRegulatoryNeutral↗ source
  • Rising employer health premiums pressure workers as industry resists change
    Workers are currently choosing health plans for the upcoming year as average family premiums for employer coverage climb to $28,303 in 2026, a 28% increase over the past five years. Employers cont…
    STAT · 11d agoNegative↗ source
  • AI as partner, competitor or crutch? Biologists weigh benefits and risks
    In a recent STAT+ opinion, UC Davis cell biology professor Paul Knoepfler discusses how artificial intelligence is reshaping biomedical research. He acknowledges AI's ability to accelerate experim…
    STAT · 11d agoNeutral↗ 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 · 12d agoPositive↗ source
  • Federal judge blocks narrow Medicaid frailty definition, expanding work-requirement exemptions
    Federal judge Richard D. Stearns in Massachusetts issued a permanent injunction against the new federal definition of “medical frailty” used to limit Medicaid work‑requirement exemptions. The judg…
    STAT · 11d agoRegulatoryNeutral↗ source
  • HHS permits compounding of six experimental peptides despite FDA scientists' safety concerns
    HHS issued a temporary policy that lets licensed pharmacies and physicians compound six experimental peptides without risk of federal enforcement. The list includes the injury-recovery duo BPC-157…
    STAT · 11d agoRegulatoryPositive↗ 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 · 11d agoEarningsNeutral↗ source
  • HHS issues temporary policy permitting compounding pharmacies to produce certain peptide drugs
    The U.S. Department of Health and Human Services announced a new policy that temporarily authorizes compounding pharmacies to manufacture specific peptide products that are not otherwise commercial…
    STAT · 11d agoRegulatoryNeutral↗ 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 · 11d 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 · 11d agoRegulatoryNegative↗ source