Tenvie doses first subject in Phase I TNV108 trial for peripheral neuropathies
Tenvie Therapeutics has dosed the first participant in its Phase I clinical trial of TNV108 to treat peripheral neuropathies. The trial …
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AstraZeneca’s COPD drug gains third Phase III win
AstraZeneca’s tozorakimab has shown benefit in a third Phase III trial in chronic obstructive pulmonary disorder (COPD). In the MIRANDA trial …
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Atsena secures DMC approval for LIGHTHOUSE trial
Atsena Therapeutics is set to proceed with the pivotal Part C cohort of its Phase I/II/III LIGHTHOUSE trial of ATSN-201 …
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AAN 2026: Phase III success for azetukalner in focal epilepsy paves approval path
On 19 April, at the 2026 American Academy of Neurology (AAN) meeting, in the late-breaking science session, Xenon Pharmaceuticals announced …
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Novo Nordisk to seek oral sickle cell therapy approval after Phase III victory
A Phase III trial of Novo Nordisk’s once-daily tablet has met both co-primary endpoints, reducing vaso-occlusive crises (VOC) and increasing …
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AAN 2026: Phase III success for azetukalner in focal epilepsy paves approval path
On 19 April, at the 2026 American Academy of Neurology (AAN) meeting, in the late-breaking science session, Xenon Pharmaceuticals announced …
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Novo Nordisk to seek oral sickle cell therapy approval after Phase III victory
A Phase III trial of Novo Nordisk’s once-daily tablet has met both co-primary endpoints, reducing vaso-occlusive crises (VOC) and increasing …
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Trump backs psychedelics for mental health in new executive order
US President Donald Trump has signed an executive order focused on accelerating the route of psychedelics to the market, adding …
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Akamis Bio reports early data from NG-350A Phase Ib trial
Akamis Bio has announced encouraging initial findings from its ongoing Phase Ib trial of the oncolytic immunotherapy NG-350A in combination …
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The future of quality in CDMOs: The five-stage journey to an advanced Pharmaceutical Quality System (PQS)
In the first part of our Q&A with Grace Breen, SVP, Quality, Sharp, we explored valuable insights derived from her …
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Four ways to build a secure and scalable CGT distribution network
CGTs offer potentially life-changing treatment for a broad spectrum of complex diseases, from genetic conditions to cancers. The pace of …
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Agenus announces Phase II results from gastroesophageal cancer therapy
Agenus has reported results from a Phase II trial, evaluating the combination of botensilimab (BOT), balstilimab (BAL), and agenT-797 alongside …
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Roche to launch global study of Elevidys following EU rejection
Roche will launch a global Phase III trial of its Duchenne muscular dystrophy (DMD) gene therapy Elevidys (delandistrogene moxeparvovec), after …
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Acerand reports first-in-human trial results for ACE-106 therapy
Acerand Therapeutics has reported updated findings from its first-in-human Phase I/II study ACE-106-001 of ACE-106 (ACE-86225106), targeting patients with advanced …
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Biomarker-led trials to guide the future of precision psychiatry
As the neuroscience treatment landscape continuously evolves towards the wider use of precision treatment options, biomarker-led trials are emerging as …
