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  • Setara Biosciences launches with $90 million to pursue Charcot-Marie-Tooth and other rare-disease therapies
    Setara Biosciences announced its formation on Friday, backed by $90 million of financing to advance a pipeline of experimental medicines. The company’s first candidate targets the genetic disorder…
    BioPharma Dive · 13d agoDealPositive↗ source
  • Aspen Neuroscience and Bambusa raise $310M combined in IPOs
    Aspen Neuroscience, a biotech focused on cell therapy for Parkinson's disease, announced it will raise about $141 million through its initial public offering scheduled for Friday. Bambusa, a start…
    Endpoints · 13d agoDealPositive↗ source
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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 · 13d 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 · 13d agoDealNeutral↗ source
  • Aspen Neuroscience raises $140M IPO to advance Parkinson’s cell therapy
    Aspen Neuroscience, a San Diego biotechnology company, completed an initial public offering, selling roughly 9.4 million shares at $15 each and raising about $140.6 million. The capital will be di…
    BioPharma Dive · 13d agoDealPositive↗ 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 · 13d 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 · 13d 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 · 13d agoNegative↗ source
  • Podcast examines Merck and Moderna’s mRNA cancer vaccine data presented at ESMO
    The latest episode of STAT’s biotech podcast "The Readout LOUD" focused on the mRNA cancer vaccine being co‑developed by Merck and Moderna, using data shown at the European Society for Medical Onco…
    STAT · 13d agoNeutral↗ 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 · 13d 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 · 13d agoNegative↗ source
  • Congress must restore independence of scientific advisory panels after controversial firings
    The authors note the recent dismissal of two vice chairs of the U.S. Preventive Services Task Force by HHS Secretary Robert F. Kennedy Jr., stressing the panel’s role in reviewing evidence to guide…
    STAT · 13d agoRegulatoryNegative↗ source
  • STAT reporters outline how upcoming midterms could reshape US vaccine, drug policy and the MAHA movement
    STAT's weekly video series STATus Report aired from Boston, the historic heart of American democracy, as the nation heads toward the midterm elections. The episode features reporters from the D.C.…
    STAT · 13d agoNeutral↗ source
  • FDA and CMS work to prevent regulatory clash as states move to test clinical AI
    Officials at the FDA and CMS are working behind the scenes to avoid a regulatory clash as more states plan to test artificial intelligence tools that perform clinical tasks. The tension arises fro…
    STAT · 13d agoRegulatoryNeutral↗ 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 · 13d 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 · 13d 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 · 13d 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 · 13d 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 · 13d 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 · 13d agoDealNeutral↗ source
  • STAT+: Pharmalittle: We’re reading about AstraZeneca cost-cutting, Sun Pharma facility problems, and more
    AstraZeneca has launched a three-year cost-cutting program that aims to slice off $1.5 billion a year, with the savings reinvested in R&D.
    STAT · 13d agoRegulatoryNeutral↗ source
  • Patient billed $1,756 after routine urgent-care visit for UTI at Texas clinic
    A woman in Allen, Texas thought she was getting a standard urgent‑care treatment for a urinary tract infection. She provided a urine sample, received a diagnosis and a prescription, and paid a mode…
    STAT · 13d agoNegative↗ 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 · 13d agoPositive↗ source
  • Election stress linked to higher risk of arrhythmias and heart attacks, study finds
    Elections can create heightened stress that may affect cardiovascular health, according to recent research. The study highlights a link between the emotional strain of voting periods and increased…
    STAT · 13d agoNegative↗ source
  • Lancet series highlights men’s health paradox and rising urgent-care costs
    The Lancet has launched a new series examining why men consistently experience poorer health outcomes than women despite advantages in certain areas. The series points to gaps in research, screeni…
    STAT · 13d agoNegative↗ source