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The EMA and HMA have published their joint strategy for the next five years, detailing how the regulatory network can continue the supply of safe and effective medicines.
The European Medicines Agency's CHMP has started a rolling review of Ad26.COV2.S, Johnson & Johnson's COVID-19 vaccine.
The first patient with bronchiectasis has been dosed in the Phase III ASPEN study of brensocatib, a reversible inhibitor of dipeptidyl peptidase 1.
The company has submitted for Emergency Use Authorization in the US and Conditional Marketing Authorization in Europe for its mRNA-1273 vaccine against COVID-19.
Dr Ash Ramzan, founder and principal consultant at Woodley BioReg, discusses how the COVID-19 pandemic has forced regulatory processes to adapt, focusing on the regulatory flexibilities introduced by the UK’s MHRA.
If the Conditional Marketing Authorization application is approved, the COVID-19 vaccine BNT162b2 could be used in the EU by the end of 2020.
The EMA recommends updating the product information for chloroquine and hydroxychloroquine after confirming a link between these medicines and psychiatric disorders.
The WHO group concluded there is currently no evidence that remdesivir improves survival when reviewing data from 7000 hospitalised COVID-19 patients.
The EMA's safety monitoring plan outlines how new information after authorisation of COVID-19 vaccines will be collected and reviewed.
The rolling review will shorten the approval timeframe by evaluating data on the safety, efficacy and quality of the mRNA-1273 vaccine as it becomes available.
The European Medicines Agency committee reports its November findings, including five drugs recommended for marketing authorisation.
The European Commission has approved Forxiga (dapagliflozin) for use in the EU to treat symptomatic chronic heart failure with reduced ejection fraction.
There are significant interpretational differences between the European Medicines Agency (EMA) and US Food and Drug Administration (FDA)’s guidance on active pharmaceutical ingredient (API) starting materials. In this article, Dave Elder explores the ambiguity in guidance from both agencies and addresses why industry struggles to identify and justify starting materials…
Behind every technological advance there is often a leadership story just as interesting. In this article, Ben Woollard highlights key leadership behaviours that have been fundamental in biological innovation and suggests how businesses can implement these attributes to strive forward in a new era of biologics.
The impact of COVID-19 is wide-reaching with disruptions to supply chains likely to continue over the coming years. In this article, Dave Elder discusses the effect of the pandemic on the supply and demand of critical medicines and what this means for pharma supply chains.
