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1,481 stories matching this filter · ← front page

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  • 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 · 29d 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 · 28d agoDealPositive↗ source
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  • 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 · 28d 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 · 28d 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 · 29d 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 · 29d 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 · 28d 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 · 28d 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 · 29d 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 · 29d 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 · 29d 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 · 29d 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 · 29d 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 · 29d agoEarningsNegative↗ source
  • Zealand Pharma to invest up to $1.2 billion in Generate’s AI platform for obesity drug development
    Zealand Pharma announced a partnership with Generate:Biomedicines to use the latter's generative‑AI platform for creating new multispecific drug candidates aimed at obesity and metabolic disorders.…
    BioSpace · 29d agoDealPositive↗ source
  • J&J Q3 earnings fall short of expectations as stock slides, BMS reports mixed trial outcomes and RevMed highlights subgroup data
    Johnson & Johnson reported third‑quarter results that met analyst forecasts, driven by its innovative medicines segment, but the company’s stock dropped about 4% as the med‑tech division lagged beh…
    BioSpace · 29d agoEarningsNegative↗ source
  • Verastem’s experimental KRAS drug shows early promise in small study, shares jump 18%
    Verastem Oncology announced early data from a small study of its experimental drug VS-7375, which targets the KRAS G12D mutation. The study enrolled patients with metastatic pancreatic ductal aden…
    BioPharma Dive · 29d agoPositive readoutPositive↗ source
  • GSK to cut over 1,200 jobs at Belgian sites as $2.5 bn restructuring continues
    GSK announced it will eliminate more than 1,200 positions across its Belgian facilities, following an earlier closure of a German vaccine plant that cut about 650 jobs. The reductions are part of…
    BioSpace · 29d agoLayoffsNegative↗ source
  • UK regulator MHRA unveils multi-year plan to speed AI-driven drug oversight
    The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released a multi-year strategy aimed at keeping its regulatory framework patient-focused as artificial intelligence and persona…
    raps · 1mo agoRegulatoryNeutral↗ source
  • European biotech CEOs divided on whether US or China will lead future partnership deals, Europe seen as lagging
    A BIO-Europe survey of 81 leaders from privately‑owned European biotech companies found the group split on which region will dominate future innovation partnerships. Twenty‑nine respondents said th…
    BioSpace · 1mo agoNeutral↗ source
  • Jazz CEO urges industry to boost gender diversity in biopharma leadership
    Renee Gala, the newly appointed chief executive of Jazz, said her own sponsors took chances on her and urged the biopharma sector to do the same to revive momentum for gender equity in leadership.…
    BioSpace · 1mo agoNeutral↗ source
  • FTC seeks contempt ruling against Martin Shkreli for breaching lifetime pharma ban
    The Federal Trade Commission has asked a judge to hold Martin Shkreli in contempt for allegedly breaching the lifetime ban that was imposed after his 2022 release from prison. The agency alleges t…
    BioSpace · 29d agoRegulatoryNegative↗ source
  • Verdiva ends mid-stage study of oral GLP-1 amid ‘market evolution’
    The candidate is an oral version of ecnoglutide, a subcutaneous formulation of which is approved in China for type 2 diabetes and weight management. Pfizer owns commercialization rights for ecnoglu…
    BioSpace · 29d ago↗ source
  • Roche signs $1 billion deal with China’s Rona Therapeutics for RNAi obesity drug
    Roche announced a new agreement with Chinese biotech Rona Therapeutics to acquire an experimental RNA interference therapy targeting the protein ALK7 for obesity. Under the terms, Roche will pay $…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Study urges regulators to adopt cloud platforms to speed drug approvals
    A new study led by Nina Cauchon of Amgen and co-authors, published in the Journal of Pharmaceutical Sciences, calls for broader use of cloud-based platforms by regulatory agencies. The authors arg…
    raps · 1mo agoRegulatoryPositive↗ source