CDMO delivers 4,000 doses of COVID-19 vaccine candidate for Phase II/III trial
Advent announced it has manufactured and delivered the first 4,000 doses of the AZD1222 vaccine candidate for the University of Oxford clinical trial.
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Experimental stem cell therapy trial for COVID-19 initiated
Researchers announce the first patient has been dosed in a trial testing remestemcel-L, a stem cell therapy, in severe COVID-19 patients on ventilators.
Dose-adjusted chemotherapy regimen effective in Burkitt lymphoma trial
Researchers reveal dose-adjusted (DA) EPOCH-R chemotherapy regimen was effective across all ages of Burkitt lymphoma patients in a Phase II clinical trial.
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.
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.
