Researchers suggest system changes to limit burden of pay-for-delay deals
The changes could prevent anticompetitive practices between branded and generic pharmaceutical manufacturers, lowering drug prices for consumers.
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Two malaria vaccine candidates show signs of efficacy
Clinical trials testing potential malaria vaccines report the vaccines were well tolerated and demonstrated some efficacy, delaying Plasmodium falciparum infection.
Operation Warp Speed: developing, manufacturing and distributing COVID-19 medical countermeasures
Exploring Operation Warp Speed, the Trump Administration’s program to expedite R&D, manufacturing and distribution of medical countermeasures for COVID-19.
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.
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.
