Reaching maturity: A roadmap for Quality Excellence amid regulatory transformation
The regulatory landscape across life sciences has faced unprecedented shifts over the past year. Simultaneous realignments of FDA, EU, and …
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US Executive Order 14420 and potential implications for diphtheria vaccination
On 31 July, the US Centers for Disease Control and Prevention (CDC) published updated surveillance data for diphtheria. Diphtheria is …
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Industry and federally backed cancer trials diverge in goals, analysis finds
New analysis has revealed that there are several distinctions between the goals of federal and industry-supported oncology clinical trials, which …
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Analysts praise intismeran’s landmark Phase III win, look to further data
On 19 August, Moderna and MSD (Merck & Co) made history by netting the first late-stage victory for a cancer …
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Milestone’s etripamil nasal spray enters Phase III trial for atrial fibrillation
Milestone Pharmaceuticals has commenced a pivotal Phase III trial of its etripamil nasal spray aimed at treating atrial fibrillation with …
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Orum to begin Phase I trial of ORM-1153 after FDA clearance
The US Food and Drug Administration (FDA) has approved Orum Therapeutics' investigational new drug (IND) application for ORM-1153, a new …
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Chemo-free regimen touts breast cancer win amid targeted therapy shift
A new study has revealed that an all-targeted treatment regimen could hold potential as an effective frontline therapeutic option for …
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AstraZeneca trips in PD-1 bispecific market after Phase III NSCLC failure
On 17 August, AstraZeneca discontinued the eVOLVE-Lung02 Phase III trial of volrustomig in combination with chemotherapy in first-line metastatic non-small …
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Study finds metabolic biomarker signature to assist with early HNSCC detection
Head and neck squamous cell carcinoma (HNSCC) is a group of cancers that consists of cancers of the mouth; the …
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Enrolment opens for Adaptin Bio’s Phase I trial of glioblastoma therapy
Adaptin Bio has opened enrolment for a Phase I clinical trial to assess its Brain Bispecific T cell Engager (BRiTE) therapy, …
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Polyrizon finalises five site agreements for Nasarix trial
Polyrizon has completed agreements with five sites for its planned clinical trial evaluating Nasarix Allergy Blocker (PL-14) in patients with …
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The changing landscape of childhood infectious disease in the US
For decades, childhood vaccination has transformed the US infectious disease landscape, reducing diseases such as measles, whooping cough, and polio …
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AC Immune’s anti-inflammatory drug posts early-stage win
AC Immune’s anti-inflammatory therapy has netted a Phase I, first-in-human win in healthy volunteers, setting a positive precedent as the …
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Reforms to UK clinical trial sector showing signs of success
Reforms to the UK clinical trial system seem to be working after 82% of studies were found to hit recruitment …
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UK MHRA grants approval for Scancell’s Phase III study of iSCIB1+
Scancell Holdings has received clinical trial authorisation (CTA) from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for a …
