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Developed by Janssen, the two-dose regimen has already been given to 60,000 patients and now has the positive opinion of the Committee for Medicinal Products for Human Use (CHMP).
Tim Wilsdon and Ryan Lawlor from Charles River Associates explain why price-based procurement strategies can limit the long-term effectiveness and sustainability of vaccine programmes.
Many COVID-19 patients who are admitted to intensive care in the UK, and globally, require mechanical ventilation. However, our healthcare systems are not prepared for the vast numbers of patients requiring this form of treatment. In this article, Adrian Toutoungi expounds how government and industry is working to push production…
The COVID-19 EMA pandemic Task Force (COVID-ETF) will aid in the development, authorisation and safety monitoring of COVID-19 vaccines and therapeutics.
Marie Manley and co-authors from Sidley Austin explain the updates to regulations in the EU and UK in light of the COVID-19 coronavirus pandemic.
The European Commission has granted Esperion approval for Nilemdo, the company has sold commercialisation rights to Daiichi Sankyo.
In the face of the coronavirus pandemic, restrictions and extreme situations may require changes to ongoing or upcoming clinical trials. These are the key recommendations from the EC, MHRA and FDA.
Maurits Lugard, Josefine Sommer and Antoine Robin from Sidley Austin dissect the recently released EU guidance to accompany the MDR, on what a significant change is and how to collect clinical evidence for medical device software.
European Pharmaceutical Review brings you the latest updates from regulatory bodies across the globe in response to the COVID-19 coronavirus.
The European Commision (EC) has announced €80 million of support to aid in the R&D and production of a COVID-19 coronavirus vaccine.
FLT190 gene therapy has been granted Orphan Drug Designation based on preliminary trial data and the positive opinion of an EMA committee.
The developers of givosiran announced the European Commission (EC) has granted the drug marketing authorisation based on results of the Phase III ENVISION trial.
Drug shortages can greatly impact patients and the pharmaceutical industry. Adrian van den Hoven, Director General of Medicines for Europe, explains how to prevent and reduce the effects of medicinal scarcities in the EU.
The EMA has released a statement on its efforts to support the development of a treatment for the novel coronavirus (2019-nCoV).
The EU Medical Devices Regulation will apply in May 2020. Maurits Lugard and Josefine Sommer of Sidley Austin LLP examine what the changes mean for the medtech industry.
