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1,492 stories matching this filter · ← front page

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  • Disc Medicine reports positive Phase 3 results for bitopertin in erythropoietic porphyria
    Disc Medicine announced that its experimental therapy bitopertin achieved its primary and secondary goals in a Phase 3 trial for erythropoietic porphyria, a rare condition that makes patients extre…
    BioPharma Dive · 26d agoPositive readoutPositive↗ source
  • Merck KGaA to acquire Silence Therapeutics for $1.1 billion, gaining Phase 3 PV siRNA asset
    Merck KGaA announced it will buy Silence Therapeutics for about $1.1 billion, giving the German group a foothold in hematology. Silence, a UK-based RNA specialist, develops short interfering RNA m…
    BioSpace · 26d agoDealPositive↗ source
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  • Disc Medicine reports positive Phase 3 results for bitopertin in erythropoietic protoporphyria, setting stage for FDA resubmission
    Disc Medicine's bitopertin, being developed for erythropoietic protoporphyria (EPP), a rare blood disorder that causes painful light sensitivity, had its accelerated FDA application rejected in Feb…
    BioSpace · 26d agoPositive readoutPositive↗ source
  • Merck acquires Silence Therapeutics for $1.3B; Hansoh Pharma signs $15B deal with Roche
    German Merck announced the acquisition of Silence Therapeutics in a transaction valued at $1.3 billion. In China, Hansoh Pharma disclosed a partnership with Roche that involves a $15 billion drug…
    raps · 27d agoDealNeutral↗ source
  • EyePoint cuts half its staff and ends wet AMD trials after second Phase 3 failure, pivots to diabetic macular edema
    EyePoint said it is launching a strategic review after its investigational drug duravyu failed another Phase 3 study in wet age‑related macular degeneration. The company reported that the top‑line…
    BioSpace · 26d agoLayoffsNegative↗ source
  • Veradermics reports Phase 3 minoxidil pill boosts hair coverage in men
    After a February IPO that raised more than $256 million and a strong share rally, Connecticut‑based Veradermics now has late‑stage data for its oral minoxidil candidate. In the Phase 3 Study 304,…
    BioSpace · 26d agoPositive readoutPositive↗ source
  • Saudi Arabia rolls out biotech partnerships to support its $34.6 billion non‑oil growth plan
    Saudi Arabia’s National Biotechnology Strategy, launched in early 2024, aims to add $34.6 billion to non‑oil GDP by 2040 and create 11,000 jobs by 2030. The plan is now moving beyond policy into co…
    BioPharma Dive · 26d agoPositive↗ source
  • Merck/Moderna vaccine and Summit/Akeso bispecific therapy among key highlights at ESMO 2026
    The European Society of Medical Oncology (ESMO) meeting in Madrid this weekend will showcase several high‑profile oncology programs. Among the most watched are Merck and Moderna’s personalized can…
    BioSpace · 26d agoNeutral↗ source
  • Multispecific drug design faces growing complexity as more binding arms increase molecular options
    The industry is seeing a rapid rise in complex biologic formats such as trispecific antibodies and cell-engaging molecules. As these multispecific constructs multiply, drug developers are turning t…
    BioSpace · 26d agoNeutral↗ source
  • China proposes ban on biotech platform sales but keeps licensing deals open
    Chinese ministries of Commerce and Science and Technology released a draft policy that would prohibit the transfer of ownership for five biotech technologies, including cell and gene therapy, small…
    BioSpace · 26d agoRegulatoryNeutral↗ source
  • Experts tout amylin as promising, potentially gentler obesity target as new combo therapies near FDA review
    While GLP-1 medicines dominate the weight‑loss market, some observers argue that amylin would have been the logical primary target for obesity treatment a decade ago. Novo Nordisk’s amylin/GLP‑1 c…
    BioSpace · 26d agoPositive↗ source
  • Novartis halts Phase 2 lupus nephritis trial of Fabhalta, cites strategic reasons
    Novartis has stopped a Phase 2 study of its complement blocker Fabhalta (iptacopan) in patients with lupus nephritis, a kidney involving form of the disease. The company said the decision was base…
    BioSpace · 26d agoNeutral↗ source
  • Early CDMO engagement: balancing speed with flexibility in CMC planning
    Bringing a new therapy to the clinic requires clinical, non‑clinical, regulatory and CMC activities to move forward together. In early development, having drug material available is often on the cr…
    BioPharma Dive · 26d agoNeutral↗ source
  • Sino Biological offers validated cytokines to improve organoid culture and research
    Organoids are three-dimensional cell models that mimic key features of real tissues, and they rely on specific signaling molecules to grow and differentiate. Key cytokines such as R-spondin 1, EGF…
    BioSpace · 26d agoNeutral↗ source
  • Japan’s PMDA releases guidance on evaluating generative AI-enabled medical devices
    Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published a set of review points aimed at medical devices that incorporate generative artificial intelligence. The guidance outlines th…
    raps · 27d agoRegulatoryNeutral↗ source
  • MedTech firms grow more comfortable with FDA's Quality Management System Regulation amid inspection concerns
    At The MedTech Conference in Boston, a senior industry executive reported that the medtech sector is gradually accepting the new Quality Management System Regulation (QMSR) despite early worries.…
    raps · 27d agoRegulatoryNeutral↗ source
  • Study shows low extractables in single-use components support ADC manufacturing
    Cytiva conducted extractables testing on disposable chromatography column housings and flow kits used in antibody-drug conjugate production. The tests used dimethylacetamide (DMA) and dimethyl sul…
    BioPharma Dive · 26d agoNeutral↗ source
  • As AbbVie’s Crohn’s combo beats Skyrizi in mid-stage test, analysts laud autoimmune vision
    AbbVie’s next-gen dual-targeting therapy elicited higher rates of remission than its IL-23 inhibitor Skyrizi in a Phase 2a trial of Crohn’s disease, leading analysts to wonder if the blockbuster ca…
    BioSpace · 26d ago↗ source
  • Disc’s rebuffed rare disease drug sets up FDA redo after ‘clean’ Phase 3 sweep
    Disc Medicine’s bitopertin—rejected by the FDA in February—significantly reduced levels of a key disease biomarker and significantly increased the time patients with erythropoietic protoporphyria w…
    BioSpace · 26d ago↗ source
  • Moderna’s stock soars after Phase 3 success of melanoma vaccine with Merck
    BioPharma Dive’s latest data-visualization series charts Moderna’s dramatic stock rebound in 2026 after a period of decline. The company had struggled when demand for its COVID-19 vaccine fell, pr…
    BioPharma Dive · 29d agoPositive readoutPositive↗ source
  • Induced pluripotent stem cells gain momentum as new methods and clinical successes drive drug development
    Induced pluripotent stem cells (iPSCs) are moving from a research curiosity to a practical tool in drug development. After years of steady progress, recent advances are bringing iPSCs into the spot…
    BioSpace · 29d agoPositive↗ source
  • FDA issues warning letters to drug makers over CGMP lapses and highlights patient rep ties to industry-backed groups
    The FDA has issued warning letters to several drug manufacturers for failing to meet current good manufacturing practice requirements, citing problems with ensuring product sterility and meeting sp…
    raps · 1mo agoRegulatoryNegative↗ source
  • Iambic Therapeutics CEO discusses $150 million IPO and AI's evolving role in drug development
    Iambic Therapeutics completed a $150 million initial public offering, raising fresh capital and seeing its share price climb to about $24.50, roughly a 50% increase from earlier in the week. CEO T…
    BioPharma Dive · 29d agoDealPositive↗ source
  • FDA issues warning to Eurofins over selective microbiology data recording at Pennsylvania lab
    FDA sent a warning letter to Eurofins after inspectors found issues at its Horsham, Pennsylvania laboratory. The inspection revealed that analysts had been selectively recording results of pour-pl…
    BioSpace · 29d agoRegulatoryNegative↗ source
  • City Therapeutics raises $200 million in IPO to fund next-gen RNAi programs
    City Therapeutics, a biotech focused on RNA interference, completed a $200 million initial public offering, selling about 11.1 million shares at $18 each. The proceeds will back three drug candida…
    BioPharma Dive · 29d agoDealPositive↗ source