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2,201 stories matching this filter · ← front page

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STAT1776Endpoints1386Fierce Biotech704BioSpace695BioPharma Dive524raps234onclive165fda recalls112
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  • Instrumentation Laboratories recalls several lots of HemosIL AcuStar HIT-IgG(PF4-H) assay due to false-negative risk
    Instrumentation Laboratories (Werfen) has issued a recall of specific lots of its HemosIL AcuStar HIT-IgG(PF4-H) radioimmunoassay after the FDA identified a performance issue that could produce fal…
    fda medwatch · 11d agoCRLNegative↗ source
  • Sanofi eyes 'moonshot' drug acquisitions to offset upcoming Dupixent patent loss
    Sanofi's CFO Francois-Xavier Roger told Fierce that the company is looking at 'moonshot' treatments as potential acquisition targets to rebuild its pipeline. The push comes as the U.S. patent on D…
    Fierce Biotech · 11d agoDealNeutral
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fda medwatch111
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fda press59
Psychiatry & CNS1204
Ophthalmology1050
Endocrinology & Metabolism775
Pain775
Nephrology759
↗ source
  • Sanofi plans to pursue higher European drug prices rather than delay product launches under Trump policy
    Sanofi indicated it may seek higher drug prices in Europe as part of a deal related to President Trump's pricing policies. Unlike other major European pharma companies that have warned the policie…
    Endpoints · 11d agoNeutral↗ source
  • Gilead places CAR-T program on partial hold after ICANS cases; Agios delays PDUFA submission
    Gilead announced a partial clinical hold on its CAR-T therapy after several patients experienced immune effector cell-associated neurotoxicity syndrome (ICANS). The hold will pause enrollment and…
    Endpoints · 11d agoRegulatoryNegative↗ source
  • AstraZeneca hints restructuring may trim R&D budget and move trials to emerging markets
    AstraZeneca's chief executive Pascal Soriot told journalists that the company's new restructuring program could lead to cost reductions in research and development and may see some clinical trials…
    Endpoints · 11d agoNegative↗ source
  • Sanofi says no major restructuring despite upcoming Dupixent patent expiration
    Sanofi's new chief executive, Belén Garijo, said after six months in charge that the company will not embark on a major overhaul of its business or research pipeline. The comment was made as the b…
    Endpoints · 11d agoNeutral↗ source
  • AstraZeneca launches $1.5 billion annual cost-saving plan to offset late-stage trial setbacks
    AstraZeneca announced a new cost‑saving initiative targeting $1.5 billion of annual expenses. The move follows a series of late‑stage clinical trial failures that have pressured the company's pipe…
    Endpoints · 11d agoNegative↗ 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
  • Nova Biomedical issues safety instructions for StatStrip Glucose Hospital Meter Gen 2.0
    Nova Biomedical has sent a letter to customers using the StatStrip Glucose Hospital Meter System Gen 2.0, advising updated use instructions while a software fix is prepared. The FDA classified the…
    fda medwatch · 11d agoCRLNegative↗ source
  • 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
  • Setara Biosciences raises $90 million to advance rare-disease pipeline after Actio spin-out
    Actio Biosciences shipped its precision epilepsy drug to Jazz Pharmaceuticals and then separated the rest of its genetics-driven pipeline into a new company called Setara Biosciences. Setara has s…
    Endpoints · 11d agoDealPositive↗ 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
  • 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
  • Anthropic appoints former Genentech scientist Nathan Frey to lead drug discovery after acquiring Coefficient Bio
    Anthropic, the AI company, recently bought biotech startup Coefficient Bio. Following the acquisition, the startup’s founder Nathan Frey, who previously worked at Genentech on machine‑learning proj…
    Endpoints · 11d agoNeutral↗ source
  • Former Be Bio chief Joanne Smith-Farrell appointed CEO of Orbis Medicines as Enanta CEO Jay Luly announces retirement
    Former Be Bio Pharmaceuticals CEO Joanne Smith-Farrell has joined Orbis Medicines as its new chief executive. Orbis, a startup backed by Eli Lilly and Novo Nordisk, focuses on developing oral macr…
    Endpoints · 11d agoNeutral↗ source
  • AI-Driven Biotech Startups May Soon Operate With Zero or One Employee, Says Endpoints News Live Discussion
    Endpoints News hosted an AI-focused event in New York, after which executive editor Drew Armstrong announced a live discussion titled "Is biotech's future full of zero and one employee startups?" s…
    Endpoints · 11d agoNeutral↗ 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
  • Eli Lilly beats Q3 revenue forecasts, lifts full-year outlook
    Eli Lilly reported third-quarter revenue of $24.4 billion, roughly $2 billion above analysts' expectations. The outperformance underscores the company's strong position, driven in part by its GLP-…
    Endpoints · 12d agoEarningsPositive↗ source
  • Bristol Myers Squibb emphasizes pipeline strength and later-stage partnership focus amid patent cliff concerns
    Bristol Myers Squibb used its latest earnings call to outline how it plans to address an upcoming patent cliff that threatens revenue from several key products. Executives said the company is rely…
    Endpoints · 12d agoEarningsPositive↗ 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
  • Merck R&D chief says company has outpaced rivals with its sac-TMT cancer platform
    Dean Li, the head of Merck Research Laboratories, said the company believes its sac-TMT cancer program gives it a competitive edge over other firms developing next-generation oncology therapies. T…
    Endpoints · 12d agoPositive↗ source
  • UK secures £500m biopharma investment as Vertex commits over £300m to new Oxford R&D hub, while Teva plans New Jersey plant closure
    The UK government’s autumn budget has attracted about £500 million in new biopharma commitments, signalling strong support for the sector. Vertex Pharmaceuticals disclosed that it will put more th…
    Endpoints · 12d agoDealNeutral↗ source
  • Ono Pharma’s endocannabinoid drug ONO-1110 fails five Phase 2 trials, prompting broader concerns
    Ono Pharma reported that its experimental endocannabinoid modulator ONO-1110 did not achieve the primary efficacy endpoint in five separate Phase 2 clinical trials. The failures span multiple indi…
    Endpoints · 12d agoNegative readoutNegative↗ source