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1,674 stories matching this filter · ← front page

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  • Setara Biosciences raises $90 million Series A to advance Jazz-spun rare disease programs
    Setara Biosciences has been created to focus on a set of rare-disease assets that Jazz Pharmaceuticals retained after acquiring Actio Biosciences. The new company secured $90 million in Series A f…
    BioSpace · 11d agoDealPositive↗ source
  • Bracco to invest $230M in new US contrast media plant, creating 200 jobs
    Bracco Diagnostics announced a $230 million investment to build its first U.S. manufacturing facility for injectable contrast media in Sanford, North Carolina. The plant is slated to create about…
    Fierce Biotech · 11d agoDealPositive↗ source
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  • Molecular Partners to cut up to 44% of staff as it shifts focus to radiotherapy pipeline
    Molecular Partners announced it will lay off up to 44% of its workforce, affecting as many as 55 positions, as the Swiss biotech redirects its limited cash toward a radiotherapeutic program. The c…
    Fierce Biotech · 11d agoLayoffsNegative↗ source
  • FDA rolls out new inspection coordination plan, lifts estradiol patch warning and HHS permits compounding of six peptides
    FDA's drug center and inspections office have agreed on a new concept of operations (ConOps) to better coordinate inspections and compliance activities. A U.S. senator introduced draft legislation…
    raps · 11d agoRegulatoryNeutral↗ source
  • AstraZeneca drops two early-phase prostate cancer programs
    AstraZeneca announced it is terminating development of two early-phase prostate cancer candidates, AZD9750 and AZD8359, as part of a quarterly pipeline review. AZD9750, an oral androgen-receptor d…
    Fierce Biotech · 11d agoNegative↗ source
  • Bambusa Therapeutics exceeds IPO target raising $169 million, while Aspen Neuroscience falls short with $141 million
    Bambusa Therapeutics announced that its initial public offering was upsized, selling more shares at the midpoint of its $15‑$17 range and raising about $168.9 million, exceeding the $150.4 million…
    Fierce Biotech · 11d agoDealNeutral↗ source
  • Acumen scraps sole asset after Alzheimer’s fail, plunging stock 80%
    Acumen will implement cash-saving strategies and assess its options after sabirnetug failed to beat placebo, leaving the biotech without a clinical program.
    BioSpace · 11d agoRegulatoryNeutral↗ source
  • 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
  • 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
  • Merck projects continued investment and growth as Keytruda patent expires
    Merck reported third‑quarter results on an investor call, saying sales expectations were above forecasts thanks to strong performance of subcutaneous Keytruda and the pulmonary arterial hypertensio…
    BioSpace · 11d agoEarningsPositive↗ source
  • 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
  • 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
  • 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
  • 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
  • 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 · 11d agoRegulatoryNegative↗ 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 · 12d 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 · 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
  • 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 · 12d 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 · 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