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  • Estuary Biotherapeutics raises $93 million Series A to develop gene therapies for ADPKD
    Estuary Biotherapeutics, a California gene‑therapy startup backed by Biogen, announced a $93 million Series A financing led by RA Capital. The capital will support development of two genetic medic…
    BioPharma Dive · 29d agoDealPositive↗ source
  • FDA issues warning letters to drug makers and a lab over CGMP and GLP violations
    FDA sent warning letters to several drug manufacturers for not meeting current good manufacturing practice (CGMP) requirements. The letters point to issues such as ensuring final product sterility…
    raps · 1mo agoRegulatoryNegative↗ source
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  • City Therapeutics raises $200M in IPO to fund thromboembolic disease pipeline
    City Therapeutics, an RNA interference biotech focused on thromboembolic diseases, completed an initial public offering that raised $200 million. The company sold about 11 million shares at $18 ea…
    BioSpace · 29d agoDealPositive↗ source
  • Estuary sails into kidney disease space with $103M for gene therapies
    Estuary Biotherapeutics is seeking to address the root cause of autosomal dominant polycystic kidney disease with two gene therapy programs based on science from Yale.
    BioSpace · 29d ago↗ source
  • OrbiMed raises two new life sciences funds worth $3B with one aiming for Asia
    The sixth cycle of OrbiMed’s Asia Partners fund included one with more than $1 billion earmarked for life science companies based on the Eastern continent.
    BioSpace · 29d ago↗ source
  • AstraZeneca teams with insitro in up to $1.5 billion AI partnership to target MASH and cardiomyopathies
    AstraZeneca announced a partnership with AI-driven biotech insitro, committing up to $1.5 billion to discover new drug targets for metabolic dysfunction-associated steatohepatitis (MASH) and cardio…
    BioSpace · 1mo agoDealPositive↗ source
  • FDA launches Rare Disease Framework Initiative to overhaul review process
    The FDA announced a new Rare Disease Framework Initiative aimed at redesigning how therapies for rare conditions are regulated. The initiative will move away from a one-size-fits-all model, instea…
    BioPharma Dive · 1mo agoRegulatoryPositive↗ source
  • Paul Stoffels launches Armed Cell Therapeutics, acquires Galapagos CAR-T assets for ~ $240 million
    Paul Stoffels, former J&J executive and ex‑CEO of Galapagos, has co‑founded a new Belgian biotech called Armed Cell Therapeutics. The company announced a licensing deal to acquire the CAR‑T cell t…
    BioSpace · 1mo agoDealNeutral↗ source
  • Arrowhead’s siRNA shows strong tau reduction in early human study, outpacing other BBB platforms
    Arrowhead Pharmaceuticals reported that its investigational siRNA candidate ARO-MAPT produced notable reductions in cerebrospinal fluid tau in a Phase 1/2a trial of healthy volunteers. Doses of 2.…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • Iambic Therapeutics raises $150 million in IPO, begins Nasdaq trading under ticker IAM
    Iambic Therapeutics, an AI-driven drug discovery startup, completed an initial public offering that raised $150 million. The company sold about 9.4 million shares at $16 each and will start tradin…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Experts call for dedicated regulatory framework for clinical AI models, UK MHRA unveils AI-focused strategy
    Former FDA commissioner Scott Gottlieb, now at the American Enterprise Institute, wrote an opinion piece urging Congress to create a specific regulatory framework for artificial intelligence models…
    raps · 1mo agoRegulatoryPositive↗ source
  • EMA to cement ACT EU pilot; MHRA unveils AI-era regulatory strategy
    The European Medicines Agency announced that in January 2027 it will make permanent a pilot project that assists sponsors in preparing clinical trial applications, turning a temporary scheme into a…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Belgian startup Armed Cell Therapeutics acquires Galapagos-derived CAR-T assets for €8 million upfront
    Armed Cell Therapeutics, a new Belgian biotech chaired by former Galapagos CEO Paul Stoffels, has taken ownership of several cell therapy programs previously held by Lakefront Biotherapeutics. The…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • FDA unveils new rare disease framework to streamline evidence standards and speed therapies
    The FDA announced a new Rare Disease Framework Initiative aimed at standardizing how scientific evidence is evaluated for rare disease therapies. The framework seeks to apply consistent clinical t…
    BioSpace · 1mo agoRegulatoryPositive↗ source
  • Vanda halts Novartis-originated social anxiety drug after Phase 3 miss
    Vanda Pharmaceuticals announced it is suspending development of VQW-765, a social anxiety disorder candidate licensed from Novartis, after the drug failed to demonstrate a statistically significant…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • FDA issues warning letters to manufacturers over CGMP and GLP violations
    The U.S. Food and Drug Administration has sent warning letters to multiple drug manufacturers for failing to meet current good manufacturing practice requirements. The agency highlighted problems e…
    raps · 1mo agoRegulatoryNegative↗ source
  • Experts call for Congress to create a dedicated regulatory framework for AI models used in academic medical centers
    On Oct. 15, 2026, several health policy experts voiced support for a new regulatory approach specifically aimed at clinical artificial‑intelligence models that are developed and deployed in academi…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Webinar Explores How US Biotechs Can Compete and Collaborate with China’s Growing Industry
    BioSpace is hosting a webinar titled "The China question: Can US biotechs lead as investment heads east?" on October 15, 2026. The event will feature a panel of experts who will discuss how China i…
    BioSpace · 1mo agoNeutral↗ source
  • Cytiva podcast highlights decision confidence as key bottleneck in biopharma development
    In a recent episode of the Denatured podcast, hosted by BioSpace Insights director Jennifer Smith-Parker, the conversation focused on the challenges facing biopharma companies. The guest, Nicolas P…
    BioSpace · 1mo agoNeutral↗ source
  • FDA launches rare disease framework initiative
    A new initiative from the US Food and Drug Administration (FDA) aims to develop “an optimized, fit-for-purpose” framework to facilitate the development and marketing of treatments for rare diseases…
    raps · 1mo ago↗ source
  • CVS agrees to $315 million settlement over alleged improper opioid prescriptions
    CVS Pharmacy has agreed to pay $315 million to settle federal allegations that it dispensed unnecessary opioid prescriptions. The Justice Department claims the company filled prescriptions that we…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ source
  • Arrowhead’s experimental RNAi drug ARO-MAPT cuts tau protein by 73% in early human trial
    Arrowhead Pharmaceuticals said its experimental RNA interference therapy, ARO-MAPT, lowered the Alzheimer’s‑linked tau protein in a first‑in‑human study of healthy volunteers. The early‑stage tria…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Gilead invests up to $1.87 B in Vir Biotechnology for three T-cell engagers
    Gilead Sciences announced a licensing agreement with Vir Biotechnology that includes an equity investment and potential milestone payments totalling up to $1.87 billion. The upfront component is $…
    BioSpace · 1mo agoDealPositive↗ source
  • Verastem reports robust response in pancreatic cancer subgroup where Revolution's drug lagged
    Verastem Oncology announced that its KRAS G12D‑targeting inhibitor VS‑7375 showed strong activity in a Phase 1/2 trial that includes patients with advanced solid tumors. In the pancreatic cancer co…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • Johnson & Johnson shares drop 6% after earnings meet forecasts but show weak medical device outlook
    Johnson & Johnson reported third‑quarter results that met Wall Street expectations and raised its 2026 financial guidance, yet the stock fell about 6% on the day. Analysts highlighted an underwhel…
    BioPharma Dive · 1mo agoEarningsNegative↗ source