After having received more data from the company, EMA is expecting Astra Zeneca to submit a conditional marketing application for its #COVID19vaccine next week. Possible conclusion - end of Jan, depending on data and evaluation progress. #EMAPublicMeeting2

The vaccine from Janssen-Cilag International N.V. is currently under rolling review. A date for submission of a marketing authorisation application has not been confirmed. As we have done for all #COVID19vaccines, we will communicate once such application is received.

EMA: COVID-19 Vaccine AstraZeneca: benefits still outweigh the risks despite possible link to rare blood clots with low blood platelets | European Medicines Agency europa.eu/!fK84jk via EU Medicines Agency

EMA’s safety committee (#PRAC) is continuing its evaluation of very rare cases of unusual blood clots in people vaccinated with the AstraZeneca#COVID19 vaccine 👉 bit.ly/2PHuJFM #COVID19Vaccines #medicine

EMA has started a rolling review of data on sotrovimab (also known as VIR-7831 and GSK4182136) a monoclonal antibody developed by GlaxoSmithKline and Vir Biotechnology, for the treatment of #COVID19. Follow the announcement here:bit.ly/3tyujzO

EMA is monitoring very closely the data on the Indian variant. We are seeing promising evidence that mRNA vaccines would be able to neutralise this variant. #EMAPresser

EMA’s human medicines committee (#CHMP) recommends 8 #medicines for approval at its May 2021 meeting:bit.ly/3yvJMUI

It seems that the 4 vaccines authorised in the EU 🇪🇺 protect against all strains, including the delta variant. First real-world data suggest that: ➡️2 doses of vaccines protect against the delta variant ➡️antibodies from the approved vaccines neutralise this variant. #EMAPresser

EMA has published the clinical data supporting the conditional marketing authorisation of Vaxzevria, previously #COVID19Vaccine AstraZeneca. ema.europa.eu/en/human-regul… #ClinicalData Visit clinicaldata.ema.europa.eu/web/cdp/home

EMA recommends granting a marketing authorisation in the 🇪🇺 for Trodelvy, a first-in-class #medicine to treat an aggressive form of #breastcancer: ema.europa.eu/en/news/first-…

EMA recommends authorising the oral antiviral #Paxlovid for treating #COVID19 in adults who do not require supplemental oxygen and who are at increased risk of severe disease. 👉ema.europa.eu/en/news/covid-…

If taken in the first days of COVID symptoms appearing, the new antiviral drug could reduce hospitalisations and death in at-risk people by 90 per cent, according to its maker. Better still, it's taken orally with water. 🚰 Read more 👇 euronews.com/next/2022/01/2…

EMA started the evaluation of applications for adapted versions of Comirnaty and Spikevax. #COVID19vaccines

On the World Duchenne awareness day #WDAD2022 let's remember that only by working together we can hope to find a brighter future. Share the word. Raise awareness.

What are the challenges and opportunities that #psychedelics present as potential treatments in #mentalhealth disorders: see the position of KOLs in #regulatory #neuroscience in this collaborative work thelancet.com/journals/lance…

Our Guideline on Clinical investigation of medicinal products in the treatment of depression just published here: europa.eu/!yW6dYK via EU Medicines Agency

EMA will host a Multi-stakeholder workshop on the guideline on clinical investigation of medicinal products in the treatment of epileptic disorders | European Medicines Agency europa.eu/!tTgDFr via EU Medicines Agency Date:29/01/2024 Location:Online

To address the topic of effective and safe use of #psychedelics we are holding a multi-stakeholder workshop – "Towards an EU regulatory framework for psychedelics". Check out the agenda and the topics here: europa.eu/!xMpqMf

To gather input for our revised guideline for treatment of epileptic disorders, we will organize a one-day workshop -29 Jan 2024. More info here: europa.eu/!qHYNBc

📢The CHMP recommends authorising a new treatment for early #AlzheimersDisease in the EU. Leqembi is intended for treatment of mild dementia and cognitive impairment in a restricted patient population with a specific genetic make-up. 👉 ema.europa.eu/en/news/leqemb…