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The rolling review will assess CVnCoV’s efficacy and immunogenicity data as it becomes available, speeding the decision process for an eventual marketing authorisation application.
The European medical cannabis market lacks a common regulatory framework; Peter Kohut charts a route through the complexity and highlights opportunities for the taking.
![Jazz Pharmaceuticals Sign with Logo [Credit: Michael Vi / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Jazz-pharmaceuticals-300x278.jpg)
![Jazz Pharmaceuticals Sign with Logo [Credit: Michael Vi / Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/Jazz-pharmaceuticals-e1612534960797.jpg)
According to Jazz Pharmaceuticals, the combined company will be a leader in neuroscience, well positioned to maximise the value of its diversified portfolio.
J&J have submitted Phase III trial data in their application to the FDA for emergency authorisation of their COVID-19 vaccine candidate.
The review will evaluate data from preclinical and clinical studies of NVX-CoV2373 to expedite the vaccine’s marketing authorisation approval later.
The EMA's CHMP has begun a rolling review of REGN-COV2, Regeneron's COVID-19 antibody candidate, after successful pre-clinical trials.
The committee for human medicinal products recommended AstraZeneca’s COVID-19 vaccine be granted conditional marketing authorisation alongside 12 other approvals.
In a Phase II trial, sotorasib was shown to be effective against pre-treated non-small cell lung cancer (NSCLC).
The EMA has accepted Global Blood Therapeutics' marketing authorisation application for Oxbryta (voxelotor) to treat haemolytic anaemia in sickle cell disease.
Sarah Ellson from Fieldfisher spoke with European Pharmaceutical Review to discuss the position of medicinal cannabis in the UK and the impacts of Brexit.
The EMA has received a conditional marketing authorisation application for the Oxford-AstraZeneca COVID-19 vaccine.
Moderna's COVID-19 vaccine has been approved in the EU with a conditional marketing authorisation by the European Commission.
Gabriela Marton sets out some of the EU-associated regulatory challenges life sciences companies will need to navigate if they want to take advantage of the rise of biosimilars.
After the US, Europe is considered the second most attractive market for serving patient needs while realising commercial value from innovative drugs. However, the 27 EU member states each have their own approaches to pricing and market access – and need tailored commercialisation and go-to-market strategies. Simon-Kucher & Partners analysed…
Europe will receive an extra 80 million doses of Moderna's mRNA-1273, a COVID-19 vaccine candidate, following the EC's decision.
