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1,104 stories matching this filter · ← front page

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  • Roche launches VENTANA BAP1 test to improve mesothelioma diagnosis
    Roche announced the global launch of its VENTANA BAP1 (SP527) test, an automated ready‑to‑use immunohistochemistry assay designed for differential diagnosis of mesothelioma. The assay targets the…
    Fierce Biotech · 11d agoPositive↗ source
  • Vitality Works recalls 365 Whole Foods Ashwagandha capsules over possible Salmonella contamination
    Vitality Works Inc., based in Albuquerque, NM, announced a recall of one lot of its 365 Whole Foods Market Standardized + Full Spectrum Blend Ashwagandha capsules, 120-count, due to potential Salmo…
    fda recalls · 11d agoRegulatoryNegative↗ source
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Nephrology759
  • Third Rock partner’s brain cancer diagnosis highlights personal impact of biotech drug development
    Jigar Raythatha, a partner at Third Rock Ventures, was diagnosed with a rare form of brain cancer in 2023 after a routine MRI. On the same day his diagnosis was confirmed, Servier announced posit…
    Fierce Biotech · 11d agoPositive↗ source
  • Once Upon a Farm recalls all Tractor Wheels toddler bars over choking risk
    Once Upon a Farm announced a recall of every lot and variety of its Tractor Wheels Organic Toddler Soft-Baked bars. The company said the snack can quickly turn into a dense, dry and sticky mass whe…
    fda recalls · 10d agoCRLNegative↗ source
  • BioMarin signs up to $475 million licensing deal for new Fabry disease enzyme therapy
    BioMarin announced a licensing agreement to acquire rights to a long‑acting enzyme replacement therapy candidate for Fabry disease, paying $70 million upfront and up to $405 million in development…
    Fierce Biotech · 12d agoDealPositive↗ source
  • Gilead places partial clinical hold on two KITE-753 CAR-T trials in diffuse large B-cell lymphoma
    Gilead announced on its third-quarter earnings call that it has placed a partial clinical hold on two CAR-T trials for KITE-753 targeting diffuse large B-cell lymphoma (DLBCL). The hold affects th…
    Fierce Biotech · 12d agoRegulatoryNegative↗ 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 · 12d agoPositive↗ source
  • 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 · 12d 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 · 12d 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 · 12d 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 · 12d agoEarningsNeutral↗ 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 · 12d 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 · 12d 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 · 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
  • 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
  • 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 · 12d agoNeutral↗ 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 · 12d agoRegulatoryNegative↗ 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 · 13d 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 · 13d agoPositive readoutPositive↗ 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 · 13d agoDealPositive↗ source
  • Geron halts phase 3 Rytelo trial after data monitoring panel deems unlikely to improve survival in JAK-inhibitor-pretreated myelofibrosis
    Geron announced the discontinuation of its phase 3 IMpactMF trial of Rytelo (imetelstat) in patients with myelofibrosis who had previously failed JAK inhibitor therapy. The decision followed an in…
    Fierce Biotech · 13d agoNegative readoutNegative↗ source
  • Oura and UC San Diego Health launch trial linking smart ring data to obesity treatment outcomes
    Oura and UC San Diego Health have partnered on a multi-year clinical trial called SMART-BMI to explore how continuous data from the Oura Ring may reflect patient response to obesity therapies. The…
    Fierce Biotech · 13d agoPositive↗ source
  • FDA proposes new rare disease framework to accelerate therapy development
    During a public hearing, FDA officials outlined a newly proposed rare disease framework aimed at creating a lasting regulatory scheme. The initiative seeks to speed the development of safe and eff…
    Fierce Biotech · 13d agoRegulatoryPositive↗ source