CHMP recommends five medicines for approval in latest meeting
The European Medicines Agency committee reports its November findings, including five drugs recommended for marketing authorisation.
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The European Medicines Agency committee reports its November findings, including five drugs recommended for marketing authorisation.
The analysis reveals that mRNA-1273 was generally well tolerated and prevented COVID-19 with an efficacy of 94.5 percent in a Phase III study.
This article explores how COVID-19 has impacted clinical investigation sites and what companies could do to mitigate the effect on trials moving forwards.
Russia’s Sputnik V, a potential COVID-19 vaccine, was 92 percent effective at protecting people from the coronavirus, interim results have shown.
AstraZenaca reveals Calquence (acalabrutinib) did not increase the proportion of hospitalised COVID-19 patients who remained alive and free of respiratory failure.
The trial’s independent Data Safety Monitoring Board (DSMB) recommended that the Phase III study evaluating remestemcel-L continue based on the second interim analysis.
Subject to regulatory approval, EU member states will be supplied with the potentially highly effective BNT162b2 COVID-19 vaccine candidate.
The neutralising antibody therapy bamlanivimab (LY-CoV555) is authorised for emergency use in recently diagnosed patients who are at risk of developing severe COVID-19.
The trial was stopped because the data suggested that injections of the long-acting antiretroviral drug cabotegravir (CAB LA) are highly effective for HIV pre-exposure prophylaxis (PrEP) in women.
The COVID-19 vaccine candidate BNT162b2, made by Pfizer and BioNTech, has demonstrated over 90 percent efficacy in its first interim analysis during its Phase III trial.
The interim Phase I data suggests CVnCoV can safely induce a neutralising antibody response similar to that of convalescent COVID-19 patients with two 12μg vaccine doses.
Developers suggest that the potency, stability and manufacturability of the nanoparticle vaccine candidate could enable vaccination against COVID-19 on a global scale.
EPR’s Hannah Balfour explores pharma’s reputation prior to the pandemic and the impact of COVID-19, highlighting areas which pharma could focus on to improve consumer relations and drive public engagement and trust.
Takeda will import and distribute 50 million doses of the mRNA-1273 vaccine candidate under an agreement with Moderna and Government of Japan.
As the race to develop a COVID-19 vaccine intensifies, nations are already ramping up production capacity on a scale never seen before – but what does this mean for manufacturers? Here, Rod Schregardus makes the case for advanced planning and scheduling techniques in new and existing facilities.