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Study shows no benefit of convalescent plasma for COVID-19 patients
An NIH trial found that COVID-19 convalescent plasma did not prevent disease progression in high-risk outpatients with early symptoms.
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Clinical Development
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FDA approves Jardiance® for heart failure with reduced ejection fraction
The FDA have approved Lilly’s Jardiance (empagliflozin) to treat adults living with heart failure with reduced ejection fraction.
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FDA approve GSK’s Jemperli for patients with dMMR solid tumours
GSK receives FDA accelerated approval for Jemperli for adults with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours.
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ICMRA set out recommendations for AI regulation in medicine
The ICRMA has set out recommendations to help regulators tackle the challenges posed by artificial intelligence (AI) in medicine.
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Pfizer and BioNTech submit Phase I data to FDA for COVID-19 booster
Pfizer and BioNTech have announced the submission of initial data to the US FDA to support booster dose of COVID-19 vaccine.
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Moderna announces first patient dosed in mRNA-3705 study
Moderna have announced that the first patient has been dosed in Phase I/II study of mRNA-3705 for methylmalonic acidemia (MMA).
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Lebrikizumab displays 75 percent skin clearance in dermatitis patients
Lebrikizumab achieved at least 75 percent skin clearance in more than half of patients with atopic dermatitis (AD), shows Phase III study.
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Monoclonal antibody prevents malaria in small NIH trial
One dose of a monoclonal antibody developed at the US National Institutes of Health (NIH) prevented malaria for up to nine months.
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Parkinson’s disease market sales to reach $11.5 billion in 2029
The Parkinson’s disease market is set to triple in sales by 2029 driven by novel biologics and delivery systems, reports GlobalData.
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Enhertu improves survival in Phase III breast cancer trial
Enhertu (trastuzumab deruxtecan) significantly improved survival in the DESTINY-Breast03 Phase III head-to-head trial against trastuzumab emtansine.
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Forxiga approved in EU for chronic kidney disease treatment
Forxiga’s approval, based on unprecedented Phase III data, is the most significant advancement in chronic kidney disease (CKD) treatment in over 20 years.
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Libtayo® with chemotherapy trial stopped early due to success
Phase III trial of Libtayo® (cemiplimab) combined with chemotherapy stops early due to significant improvement in overall survival in lung cancer patients.
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Collaboration and integration to progress clinical research
Here, Lucinda Cash-Gibson and Francesco Patalano discuss why the pharmaceutical industry is collaborating to develop protocols for patient-centric integrated platform trials and what the clinical research industry may look like in future.
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Chikungunya vaccine effective in 98.5 percent of participants
Valneva’s single-shot chikungunya vaccine induced neutralising antibody titers in 98.5 percent of participants in a Phase III study.
