FDA approves Lynparza (olaparib) for HRR mutated prostate cancer
Lynparza’s approval was based on results from a Phase III clinical trial in which it improved overall survival and progression-free survival in patients with certain prostate cancers.
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The COVID-19 pandemic and clinical trial disruptions
Research suggests almost 70 percent of global clinical trials have been disrupted by enrolment suspensions caused by the COVID-19 pandemic.
Report reveals CMOs in Italy concentrated in worst-hit COVID-19 regions
According to findings, the majority of CMOs in Italy are found in the locations hit worst by COVID-19, meaning the pharma supply chain has been greatly impacted.
FDA grants priority review to Biologics License Application for sutimlimab
The FDA has granted priority review of the Biologics License Application for sutimlimab to treat haemolysis in patients with cold agglutinin disease (CAD).
IFN-α2b therapy shows promise in patients as potential COVID-19 treatment
A group of researchers has found that IFN-α2b therapy reduced blood levels of IL-6 and C-reactive protein, two inflammatory proteins found in COVID-19 patients.
Stem cells used to replace neurons in patient with Parkinson’s disease
A team has revealed that a patient who received induced pluripotent stem cells to replace lost dopaminergic neurons has reduced symptoms of Parkinson's disease.
Four UK CROs announce collaboration to work on potential COVID-19 therapeutics
A group of four CROs at BioCity Nottingham have joined forces to collectively work on the research of COVID-19 therapies.
Most UK adults believe COVID-19 vaccines and treatments should be distributed globally
A survey has revealed that the majority of adults in the UK believe governments need to work together to develop COVID-19 vaccines and treatments, which if effective, should be used worldwide.
EMA recommends updating safety information for HRT and leuprorelin
The EMA has suggested that the safety information be updated for HRT, to reflect a higher risk of breast cancer and recommends new measures for the handling of leuprorelin depot medicines.
Phase IIb trial to study hydroxychloroquine and azithromycin as COVID-19 treatment launched
A double-blind clinical trial has begun in the US to study hydroxychloroquine and azithromycin treatment in patients with COVID-19.
Spartan’s COVID-19 test recall exposes issues of rapid medical device approval, says report
Following the recall of Spartan Bioscience's COVID-19 test by Health Canada, a report suggests this demonstrates the challenges associated with rapid approval.
App to help enrol COVID-19 patients into clinical trials developed
A new software has been developed, made to help find and enrol COVID-19 positive patients to accelerate clinical trials for new drugs and vaccines.
FDA grants Fast Track Designation to Moderna’s COVID-19 vaccine
The US FDA has given Fast Track Designation to Moderna's mRNA vaccine candidate, mRNA-1273, designed to protect against COVID-19.
Doubt cast over Avigan (favipiravir) and DAS181 potential to fight COVID-19
A new report has highlighted that the early successes of Avigan (favipiravir) and DAS181 do not guarantee their efficacy against COVID-19.
Mylan partners with Gilead to manufacture remdesivir, potential COVID-19 treatment
According to a new agreement between Mylan and Gilead, the former has the rights to manufacture and distribute remdesivir in 127 countries, a drug being tested to combat COVID-19.
