EMA commissions research in preparation for monitoring COVID-19 vaccines
The research will identify sources of data to monitor coverage and effectiveness, and support pharmacovigilance of COVID-19 vaccines once they are approved.
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FDA approves Phexxi™ vaginal gel for prevention of pregnancy
The US FDA approved Phexxi™ (lactic acid, citric acid and potassium bitartrate) gel, the first non-hormonal, vaginal pH regulator contraceptive.
‘At home’ COVID-19 antibody tests: expert opinions and manufacturer warnings
Abbott has revealed its SARS-CoV-2 antibody test was not designed for at home use despite companies selling them for this purpose. Also, what do experts think about these tests?
COVID-19 vaccine induces immune response in Phase I trial
The adenovirus type 5 vectored COVID-19 (Ad5-nCoV) vaccine candidate safely induced T cell and antibody responses in 108 adults.
Global COVID-19 hydroxychloroquine trial paused over safety concerns
The WHO has paused the hydroxychloroquine arm of a global trial while it investigates safety concerns highlighted by published studies.
Company develops a COVID-19 test for use on surfaces and wastewater
IberoGEN has developed a test to detect COVID-19 for use on surfaces and wastewater in the hopes of aiding in the return to normalcy.
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.
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.
