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68 stories matching this filter · ← front page

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  • MDCG: Only manufacturers should assign UDI-DIs
    <p>The European Commission's Medical Device Coordination Group (MDCG) says unique device identifiers and device identifiers (UDI-DI) codes used between manufacturers and distributors need to be bet…
    raps · 2d ago↗ source
  • FDA issues untitled letters to Sanofi and Viatris for false advertising
    <p>The FDA’s Office of Prescription Drug Promotion recently reprimanded Sanofi and Viatris for making misleading claims about their products in emails and a television advertisement.</p>
    raps · 2d ago↗ source
  • Samsung Biologics targets $1.8B PolyPeptide buyout to expand in obesity
    With PolyPeptide manufacturing peptides such as GLP-1 medicines, Samsung Biologics has identified the deal as a way to tap into fast-growing demand for obesity drug production services.
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Pulmonology5
Infectious Disease4
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BioSpace · 2d ago
↗ source
  • Agios axes next-gen sickle cell candidate after it fails to best Novo’s asset
    Agios Pharmaceuticals’ sickle cell disease candidate didn’t prove any better than Novo Nordisk’s investigational PK activator or the biopharma’s own asset that is currently under FDA review for the…
    BioSpace · 2d ago↗ source
  • Novartis stays 'geography-agnostic' in dealmaking amid flurry of China deals
    Novartis will continue to be on the lookout for bolt-on deals below $2 billion, CEO Vas Narasimhan said Tuesday on the pharma's second quarter earnings call—though major pickups aren’t completely o…
    BioSpace · 2d ago↗ source
  • The FDA’s 505(b)(2) pathway is an underestimated engine of value creation
    The biopharma industry would do well to re-embrace the 505(b)(2) path, which allows sponsors to draw on previous findings around an existing drug even as they propose modifications to it.
    BioSpace · 2d ago↗ source
  • Dyne gets early 2027 decision date for Duchenne therapy, analysts expect ‘smooth’ review
    If approved, Dyne Therapeutics’ zeleciment rostudirsen could “capture the majority” of the exon-51 Duchenne muscular dystrophy market, given its better efficacy and dosing profile versus Sarepta Th…
    BioSpace · 3d ago↗ source
  • Axiom plans Hong Kong IPO, hoping to carve new path for US biotechs
    Axiom Biosciences is thinking outside of the box, betting on a public debut in Hong Kong to raise capital and grow into a global company.
    BioSpace · 3d ago↗ source
  • Recon: Novo sues Lilly over weight-loss drug ads; Gilead, Merck say HIV pill keeps HIV suppressed in two Phase 3 trials
    <p>Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.</p>
    raps · 3d ago↗ source
  • FDA cites companies for CGMP violations, informed consent failure
    <p>The US Food and Drug Administration has issued warning letters to several drug makers for failing to meet its current good manufacturing practices (CGMP) requirements and a company for failing t…
    raps · 3d ago↗ source
  • European Commission publishes guideline on transparency obligations under AI Act
    <p>The European Commission on Monday published new guidelines to assist providers and deployers of artificial intelligence (AI) systems in fulfilling transparency obligations under the EU’s AI Act,…
    raps · 3d ago↗ source
  • Lilly’s AtaiBeckley buy validates space as Big Pharma takes note of psychedelics
    Eli Lilly’s proposed acquisition of AtaiBeckley is “the clearest strategic validation to date” of psychedelics as an emerging pharmaceutical category, according to H.C. Wainwright. The analyst caut…
    BioSpace · 3d ago↗ source
  • FDA’s radical transparency policy for rejections runs into legal uncertainty
    Having started to publish CRLs without consulting the public, the FDA is under pressure to change course amid concerns it failed to openly and fully evaluate a complex issue.
    BioSpace · 3d ago↗ source
  • 2026 IPO class blooms again as BlossomHill, Latigo set sights on Nasdaq
    Eighteen companies have gone public this year so far, putting 2026 on pace to record the highest number of IPOs since the pandemic-driven high of 2021.
    BioSpace · 3d ago↗ source
  • Vertex’s IgA nephropathy drug derisked after Novartis, Vera approvals
    The FDA is currently reviewing Vertex Pharmaceuticals’ povetacicept, with a target action date of Nov. 30. If approved, the drug could benefit from campaigns from Novartis and Vera Therapeutics for…
    BioSpace · 4d ago↗ source
  • Type 1 diabetes pipeline making ‘remarkable progress’ toward insulin independence
    After the trailblazing approval of Sanofi’s Tzield for stage 3 type 1 diabetes, several companies, including SAB Biotherapeutics and Eledon Pharmaceuticals, are vying for a spot in the landscape wi…
    BioSpace · 4d ago↗ source
  • How Kyverna rode CAR T’s autoimmune wave to the FDA’s door
    Poised to become the first company to achieve a regulatory filing for a cell therapy in autoimmune disease, Kyverna Therapeutics is building a pipeline-in-a-product to change the treatment paradigm.
    BioSpace · 4d ago↗ source
  • Recon: BMS to construct AI supercomputer with Nividia; Tempus to acquire cancer diagnostic maker Personalis for $1.5B
    <p>Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.</p>
    raps · 4d ago↗ source
  • Asia-Pacific Roundup: TGA seeks feedback on Australian regulations for digital mental health tools
    <p>Australia’s Therapeutic Goods Administration (TGA) is holding a consultation to inform changes to the regulatory framework for digital mental health tools (DMHTs).</p>
    raps · 4d ago↗ source
  • Study: China outpaces the US in cancer approvals, lags behind on first approvals
    <p>While China's National Medical Products Administration (NMPA) approved more oncology drugs compared to the US Food and Drug Administration (FDA) from 2020 to 2025, the US regulator approved more…
    raps · 4d ago↗ source
  • MHRA touts uptick in approvals in 2025-2026 annual report
    <p>The UK's Medicines and Healthcare products Regulatory Agency (MHRA) touted its achievements over the last year its 2025-2026 annual report to Parliament, which includes approving more new drugs…
    raps · 4d ago↗ source
  • India’s life sciences sector at turning point for innovation: Report
    Structural gaps in areas including clinical execution and funding limit India’s ability to scale up innovation, according to a report from Boston Consulting Group and HealthKois.
    BioSpace · 6d ago↗ source
  • GSK culls cough program for drug at the heart of $2B Bellus bet after Phase 3 fail
    Camlipixant, which GSK picked up in its $2 billion buyout of Bellus Health in April 2023, “is unlikely to transform patient care,” the pharma said.
    BioSpace · 6d ago↗ source
  • Insmed moves closer to $6B opportunity as PAH drug shows long-term durability
    Insmed’s inhalable candidate showed “impressive” long-term efficacy in pulmonary arterial hypertension, according to analysts at Guggenheim Partners, with functional and biomarker improvements thro…
    BioSpace · 7d ago↗ source
  • FDA disavows Makary, Prasad’s papers as lawmaker blasts ‘shoot-from-the-hip’ policymaking
    Journal publications that suggested changes in FDA guidelines do not “communicate FDA policy or interpretation of a regulatory issue,” acting director Kyle Diamantas wrote in a letter to House Ener…
    BioSpace · 7d ago↗ source