News and Press Releases

Exonate announces successful completion of phase 1b/2a trial in diabetic macular oedema

Lead ophthalmology candidate EXN407 has potential to be the first topical treatment for diabetic retinopathy/diabetic macular oedema EXN407 met all endpoints and displayed encouraging biological activity in diabetic patients with...

Category: Clinical Trials
Posted: November 28, 2023

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Janssen Submits Application to the European Medicines Agency forRYBREVANT▼ (amivantamab) in Combination with Chemotherapy for the Treatment of Adult Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer After Failure of Prior Therapy

The submission is supported by data from the Phase 3 MARIPOSA-2 study featured in a Late-Breaking Presidential Symposium session at the 2023 ESMO Congress and simultaneously published in Annals of...

Category: Clinical Trials
Posted: November 23, 2023

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Commercial study set up times reduced by a third, according to new data 

26 October 2023 -- London, England -- New data from the National Institute for Health and Care Research (NIHR) shows that the National Contract Value Review has significantly reduced the...

Category: Clinical Trials
Posted: October 26, 2023

Landmark Phase 3 MARIPOSA Study Shows RYBREVANT▼(amivantamab) Plus Lazertinib Resulted in 30% Reduction in Risk of Disease Progression or Death Compared to Osimertinib in Patients with EGFR-Mutated NSCLC

Early data show an overall survival trend favoring the combination of amivantamab and lazertinib compared to osimertinib; consistent results seen in patients with and without brain metastases Late-breaking results from...

Category: Clinical Trials
Posted: October 24, 2023

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Results from Phase 2 THOR-2 Study Showed Improved Rates of Recurrence-Free Survival in Patients with High-Risk Non-Muscle-Invasive Bladder Cancer with Select Fibroblast Growth Factor Receptor Alterations Treated with Erdafitinib Versus Chemotherapy

Data from Cohort 1 of the phase 2 THOR-2 study showed oral erdafitinib reduced the risk of disease recurrence or death compared with intravesical standard-of-care chemotherapy 21 October 2023 --...

Category: Clinical Trials
Posted: October 23, 2023

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European Commission Approves ADCETRIS (brentuximab vedotin) for the Treatment of Adult Patients with Previously Untreated CD30+ Stage III Hodgkin Lymphoma in Combination with AVD  

· Approval Based on Updated Positive Overall Survival Results from the phase 3 ECHELON-1 Study for Stage III & IV Hodgkin Lymphoma  · First Significant Improvement in Overall Survival in Two Decades...

Category: Pharmaceutical
Posted: October 23, 2023

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AstraZeneca reinforces commitment to protecting the most vulnerable from serious infectious diseases at IDWeek 2023

Real-world data from INFORM study demonstrate increased risk of severe COVID-19 outcomes among all individuals with immunocompromising conditions and highlight need for additional protection FluMist Quadrivalent data support the potential...

Category: Clinical Trials
Posted: October 12, 2023

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MSD’s WELIREG▼(belzutifan) made available for the treatment of eligible adults with von Hippel-Lindau (VHL) disease in Scotland

Scotland is the first European country to accept belzutifan as a treatment for adult patients with von Hippel-Lindau (VHL) disease who require therapy for VHL-associated renal cell carcinoma (RCC), central...

Category: Pharmaceutical
Posted: October 9, 2023

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New Safety Data Suggests SPRAVATO▼ (Esketamine Nasal Spray) is More Tolerable and Effective Compared to Quetiapine Extended-Release (XR) in Adults with Treatment-resistant Major Depressive Disorder

• The new safety data is from the ESCAPE-TRD Phase 3b study• Additional findings from this study showed esketamine NS demonstrated a significant increase in the proportion of patients achieving...

Category: Clinical Trials, Drug Discovery
Posted: October 9, 2023

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Moderna Announces Positive Phase 1/2 Data from mRNA-1083, the Company’s Combination Vaccine Against Influenza and COVID-19

mRNA-1083 showed strong immunogenicity against influenza and COVID-19, with an acceptable reactogenicity and safety profile, compared to licensed standalone vaccines Company to begin phase 3 trial of mRNA-1083 in adults...

Category: Clinical Trials, Drug Discovery
Posted: October 4, 2023

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Signant Health Launches Signant Biotech to Accelerate and Streamline Clinical Development for Emerging Biopharmaceutical Organisations

3 October 2023 -- Philadelphia, US -- Signant Health, the leader in evidence generation for modern clinical trials, announced today the launch of Signant Biotech – an integrated clinical research...

Category: Clinical Trials
Posted: October 4, 2023

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Shionogi Presents New Ensitrelvir Clinical and Real-World Data Reinforcing Potential Across COVID-19 Populations at ESWI 2023

New exploratory analysis of phase 3 SCORPIO-SR study data in Asia suggests that ensitrelvir may reduce the risk of persistent and new late-onset symptoms associated with long COVID-19 over one...

Category: Clinical Trials
Posted: September 20, 2023

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Mural Health Raises $8m Led by Bessemer Venture Partners to Accelerate Growth

Funding enables Mural Health to expand its Mural Link platform to modernise the clinical trial participant experience 19 September 2023 -- Pennsylvania, US -- Mural Health Technologies, a next-generation clinical...

Category: Clinical Trials
Posted: September 20, 2023

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Invitation to learn from the best: Evening of insights and networking will honour a clinical data management stalwart

Prof Deborah Ashby to give the 2023 Sally Hollis Memorial Lecture in Macclesfield 13 September 2023 -- London, UK and North Carolina, US -- A leading global expert on clinical...

Category: Clinical Trials
Posted: September 18, 2023

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Janssen Submits MA Application to the European MedicinesAgency Seeking Approval of Erdafitinib for the Treatment of Patients with LocallyAdvanced or Metastatic Urothelial Cancer with Susceptible FGFR Alterations

Pending approval, erdafitinib, an investigational, once-daily oral pan-fibroblast growth factorreceptor (FGFR) tyrosine kinase inhibitor, will become the first therapy targeting FGFRalterations in patients with metastatic urothelial carcinoma, one of Europe’s...

Category: Clinical Trials, Drug Discovery
Posted: September 8, 2023

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