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  • 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 · 13d agoNegative readoutNegative↗ source
  • Genetic Testing Helps Refine Kidney Disease Trial Design, Says Natera Expert
    In a sponsored episode of The Top Line, Dr. Ronen Schneider, Natera's medical director of renal genetics, explains how genotype‑defined kidney disease data can improve clinical trial design. He not…
    Fierce Biotech · 14d agoPositive↗ source
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  • Eli Lilly halts phase 2 Alzheimer's trial of mevidalen after missing internal targets
    Eli Lilly announced it is removing mevidalen from its pipeline, ending a phase 2 trial in symptomatic Alzheimer's disease. The decision was disclosed during the company's third-quarter earnings up…
    Fierce Biotech · 14d agoNegative readoutNegative↗ source
  • Setara Biosciences raises $90M Series A to advance neuroscience pipeline after Jazz's $820M Actio acquisition
    Jazz Pharmaceuticals completed an $820 million purchase of Actio Biosciences in September, creating a new spinout called Setara Biosciences to house the remaining drug programs. Setara has secured…
    Fierce Biotech · 14d agoDealPositive↗ source
  • Delays in reaching clinical proof-of-concept can dramatically increase biotech cash burn
    The article explains how the timing of achieving clinical proof‑of‑concept (POC) directly affects a biotech company's cash consumption. While a study’s cost is important, the ongoing expenses of st…
    Fierce Biotech · 14d agoNegative↗ source
  • Merck says 2027 will focus on pipeline and new product launches despite recent trial wins
    Merck's chief financial officer said the company views 2027 as another year of investment, emphasizing its expanding pipeline and upcoming product launches rather than short‑term margin growth. Th…
    Fierce Biotech · 14d agoEarningsNeutral↗ 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 · 14d agoPositive↗ source
  • BMS drops $80 million neurodegeneration program after phase-1 results
    BMS announced it will not move forward with a neurodegeneration drug it licensed from Prothena, ending a program it invested $80 million in. The drug, known as BMS-986495 (formerly PRX019), comple…
    Fierce Biotech · 14d agoNegative↗ source
  • Ascletis oral GLP-1 candidate ASC30 meets primary and secondary goals in phase 2 diabetes study
    Ascletis reported that its oral GLP-1 small‑molecule candidate ASC30 achieved both its primary and secondary endpoints in a phase 2 trial involving 100 patients with type 2 diabetes. The study sho…
    Fierce Biotech · 14d agoPositive readoutPositive↗ 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 · 14d 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 · 14d 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 · 13d agoNeutral↗ 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 · 14d 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 · 14d agoRegulatoryNeutral↗ source
  • Eli Lilly consolidates US and international sales under new global markets unit as veteran exec retires
    Eli Lilly announced that long‑time executive Patrik Jonsson will retire after 36 years with the company. Jonsson has been serving as executive vice president and president of Lilly International, o…
    Fierce Biotech · 13d 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 · 14d 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 · 13d 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 · 14d agoRegulatoryNeutral↗ 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 · 14d agoPositive readoutPositive↗ source
  • Genmab's bispecific combo with Keytruda halves death risk in phase 3 head‑neck cancer trial
    Genmab announced interim results from its phase 3 LiGeR-HN1 study, showing that adding the bispecific antibody petosemtamab to Merck's Keytruda significantly improved outcomes for patients with PD-…
    Fierce Biotech · 15d agoPositive readoutPositive↗ source
  • Lilly's retatrutide outperforms Ozempic in phase 3 trial, cutting blood sugar and weight more
    Eli Lilly tested its triple-G candidate retatrutide against Novo Nordisk's Ozempic (semaglutide) in an open-label phase 3 study involving about 1,300 adults with type 2 diabetes whose glucose was n…
    Fierce Biotech · 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 · 15d 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 · 14d 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 · 14d agoDealPositive↗ source
  • Astellas commits up to $285M upfront for Audax's preclinical IL-12 program, with potential $1.05B milestones
    Astellas Pharma has entered a licensing agreement with Audax Biosciences to gain rights to the latter’s IL-12 immuno‑oncology candidate DAX‑044. Under the deal, Astellas will pay up to $285 millio…
    Fierce Biotech · 15d agoDealPositive↗ source