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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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 …
-
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 …
-
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 …
-
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 …
-
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 …
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Definium’s psychedelic prospects brighten further on Phase III success
Definium Therapeutics has notched another late-stage win for DT120 in generalised anxiety disorder (GAD) – further bolstering the drug’s market …
