Argenx’s stock rises on Phase III autoimmune myositis victory
Argenx’s stock opened 8.9% up after a Phase III trial of Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in adults with …
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Sustaining long-term follow-up in cell and gene therapies
Diego Correa, VP and global head, CAGT Center of Excellence, IQVIA, and Jip Klerks, product strategy lead, real-world solutions at …
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AstraZeneca axes NSCLC trial after bispecific deemed unlikely to best Keytruda
AstraZeneca has ended a Phase III trial of its bispecific volrustomig pitted against MSD’s blockbuster Keytruda (pembrolizumab) in non-small cell …
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Fate Therapeutics begins Phase II trial of FT819 for lupus nephritis
Fate Therapeutics has initiated and treated the first patient in RECLAIM-LN, a Phase II clinical trial evaluating FT819 in patients …
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FDA approves ArkBio’s ziresovir for Phase II trial in severe RSV
Shanghai Ark Biopharmaceutical (ArkBio) has received approval from the US Food and Drug Administration (FDA) to begin a Phase II …
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FDA approves ArkBio’s ziresovir for Phase II trial in severe RSV
Shanghai Ark Biopharmaceutical (ArkBio) has received approval from the US Food and Drug Administration (FDA) to begin a Phase II …
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ICH GCP Annex 2 will strengthen sponsor confidence in the use of DCTs and RWD
In July 2026, the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) quietly …
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Barriers stopping US biotechs from running FIH trials on home soil
A survey indicates that US biotechs would prefer to conduct first-in-human (FIH) trials in the US, but obstacles are pushing …
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FDA grants clearance for PhenoNet Phase III trial in early Alzheimer’s
PhenoNet has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase III clinical trial …
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SCRI and MSD to broaden US oncology trial access
Sarah Cannon Research Institute (SCRI) and Merck & Co (MSD) have entered a collaboration aimed at increasing patient access to …
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AI can deliver gains of $21m per drug development programme, study finds
Artificial intelligence (AI)-based clinical monitoring agents can deliver gains of up to $21m per drug development programme, as well as …
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UK study finds sharp increase in type 2 diabetes incidence
Type 2 diabetes (T2D) has posed a formidable challenge to public health throughout high-income nations due to the high prevalence …
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Taiho Oncology reports positive results in REZILIENT3 trial
Taiho Oncology, Taiho Pharmaceutical and Cullinan Therapeutics have reported that the global Phase III REZILIENT3trial assessing zipalertinib combined with platinum-based …
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Podcast: Bringing diversity to Alzheimer’s trials
In recent years, the Alzheimer’s disease market has seen several developments, including the debut of the first disease-modifying therapies (DMTs), …
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Sumitomo treats first patient in Phase I/IIa trial of DSP-3077
Sumitomo Pharma America has treated the first patient in its Phase I/IIa clinical trial of DSP-3077 for adults with non-syndromic …
