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 …
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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 …
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Belenos’ Keymed licensing deal delivers on Phase II win in rhinosinusitis
Belenos Biosciences’ bet worth up to $185m on Keymed Biosciences’ subcutaneous chronic rhinosinusitis with nasal polyps (CRSwNP) therapy is showing …
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Why your manufacturing floor is your greatest compliance risk – and opportunity
Ask any life sciences quality leader where their biggest compliance headaches originate, and you might expect them to point to …
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Investigational CRISPR therapy succeeds in patient with drug-resistant E. Coli
A patient who developed multidrug-resistant E. coli following a transplant has recovered following treatment with an investigational clustered regularly interspaced …
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Arch Biopartners plans US expansion of LSALT peptide trial
Arch Biopartners is set to expand its Phase II clinical trial of the LSALT peptide, a drug candidate targeting cardiac …
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First patient in Skylark Bio’s Phase I/II trial receives SKY-GJB2 gene therapy
Skylark Bio has dosed the first patient in its SONIX Phase I/II clinical trial assessing SKY-GJB2 as a potential gene …
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MoonLake’s nanobody boosts PsA indication hopes after Phase III success
MoonLake Immunotherapeutics’ sonelokimab has shown benefit in patients with psoriatic arthritis (PsA), with a Phase III trial meeting its primary …
