EU Medicines Agency @EMA_News@respublicae.eu

EMA routinely publishes #ClinicalData supporting the marketing authorisations and #safety monitoring of #COVID19medicines.

We are the 1⃣st regulatory authorities in the world with @GovCanHealth 🇨🇦 to provide such broad online access to clinical data.

#Transparency

🐦🔗: https://n.respublicae.eu/EMA_News/status/1605588193243439105

Our Executive Director, Emer Cooke, looks back at 2022 and gives insights into the year ahead.
Read her statement here:
👉https://www.ema.europa.eu/en/news/end-year-message-emas-executive-director-0

🐦🔗: https://n.respublicae.eu/EMA_News/status/1605562897517531136

Our Executive Director, Emer Cooke, looks back at 2022 and gives insights into the year ahead.
Read her statement here 👇

🐦🔗: https://n.respublicae.eu/EMA_News/status/1605522173296271360

RT @EU_Health: The seasonal influenza season is in full swing in Europe. With co-circulation of flu, COVID-19 & other respiratory viruses, it's a particularly challenging time or our health.

Get vaccinated: make vaccines work & help everyone stay protected this winter.

#UnitedInProtection

🐦🔗: https://n.respublicae.eu/EMA_News/status/1605512760325943296

RT @EU_HaDEA: Save the date📌

Are you thinking of applying for #HorizonEU funding under Cluster 1 '#Health' ⚕ ?

Do not miss the Info Day introducing the topics of the 2023-2024 work programme!

🗓️19 January 2023 | 9 AM

https://hadea.ec.europa.eu/events/horizon-europe-info-day-cluster-1-health-2023-01-19_en

🐦🔗: https://n.respublicae.eu/EMA_News/status/1605153725806518273

📢With @EU_Commission & the Heads of Medicines Agencies, we published recommendations to facilitate the conduct of decentralised EU #clinicaltrials. They reduce the need to travel to central trial sites, to make it easier for #patients to get enrolled.
👉https://www.ema.europa.eu/en/news/facilitating-decentralised-clinical-trials-eu

🐦🔗: https://n.respublicae.eu/EMA_News/status/1604856744106156033

RT @EU_ENV: Today we proposed a revised classification, labelling and packaging of 🧪 (CLP) to better protect our health & nature from ⚠️ chemicals

A key step towards reaching our #ZeroPollution targets ahead of the revision of the #EU_REACH Regulation in 2023

https://ec.europa.eu/commission/presscorner/detail/en/ip_22_7775

🐦🔗: https://n.respublicae.eu/EMA_News/status/1604820534247788544

At its December meeting, the Management Board heard updates on the implementation of the Clinical Trials Regulation, the Veterinary Medicinal Products Regulation and EMA’s budget.
👉https://www.ema.europa.eu/en/news/ema-management-board-highlights-december-2022-meeting

🐦🔗: https://n.respublicae.eu/EMA_News/status/1603757572313456642

The #CHMP also recommended to extend the use of #COVID19 vaccine #Spikevax 💉as a booster in children aged 6 to 11 years. ⬇️

#VaccinesWork

https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-12-15-december-2022

🐦🔗: https://n.respublicae.eu/EMA_News/status/1603711320376983556

The #CHMP recommended for authorisation the 1⃣st gene therapy to treat #haemophilia B in adults ⬇️

https://www.ema.europa.eu/en/news/first-gene-therapy-treat-haemophilia-b

🐦🔗: https://n.respublicae.eu/EMA_News/status/1603711318233649152

📢EMA's human medicines committee, the #CHMP, recommended 5⃣ new medicines for approval in the 🇪🇺:
☑️ two medicines for #cancer
☑️ a treatment for #multiplesclerosis
☑️ a medicine for a rare disease #Pompe

#PublicHealth

👉https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-12-15-december-2022

🐦🔗: https://n.respublicae.eu/EMA_News/status/1603711315444375552

❗️It is extremely important that elderly people, pregnant persons and immunocompromised patients get re-vaccinated against #influenza and #COVID19.

Vaccines that combine #flu and COVID are under development. They could simplify vaccination campaigns in the future. #EMAPresser

🐦🔗: https://n.respublicae.eu/EMA_News/status/1603694437619695621

This autumn, EMA became the 1st regulator in the 🌍 to approve #Beyfortus, a monoclonal antibody to prevent serious lower respiratory tract disease caused by #RSV in newborns & children. #EMAPresser

🐦🔗: https://n.respublicae.eu/EMA_News/status/1603694029446725635

#Influenza season epidemic kicks off early in Europe as concerns over #RSV rise and #COVID19 remains a threat.

‼️ There is a high risk that the co-circulation of these diseases will place pressure on healthcare systems in the coming weeks. #EMAPresser

🐦🔗: https://n.respublicae.eu/EMA_News/status/1603693860542205952

📢 Yesterday, EMA met with @US_FDA to define development pathways that could allow timely approval of the next generation of monoclonal antibodies. #EMAPresser
?s=20&t=I6LVdO32Vg-kMlOAiyk6Pg
RT @EMA_News: 📢Our Emergency Task Force warns that monoclonal antibodies may not be effective against emerging strains of SARS-CoV-2. Read the full statement 👇
https://www.ema.europa.eu/en/news/etf-warns-monoclonal-antibodies-may-not-be-effective-against-emerging-strains-sars-cov-2
#COVID19 #PublicHealth

🐦🔗: https://n.respublicae.eu/EMA_News/status/1603693624721637376

🔍The data show that the #safety profile of the adapted vaccines, when used as #boosters, is comparable to that of the original mRNA vaccines, for which the safety profile is well established.

#EMAPresser

🐦🔗: https://n.respublicae.eu/EMA_News/status/1603693131391795200

The data suggest that primary vaccination with #AdaptedVaccines should give rise to a broad immune response in people who have not yet been exposed to, or vaccinated against, #COVID19.

#EMAPresser ⬇️
?s=20&t=KqADz96VvID1BBfuQsfSMw
RT @EMA_News: EMA concludes that adapted mRNA #COVID19vaccines targeting the original strain and Omicron BA.4-5 subvariants of the SARS-CoV-2 virus may be used for initial vaccination.

These #AdaptedVaccines are currently only authoris…

🐦🔗: https://n.respublicae.eu/EMA_News/status/1603692963514777601

The virus is here to stay 🦠. We will have to prudently move towards a new normal, making the best use of the tools that can protect us, starting from vaccines 💉. #EMAPresser #VaccineWork

🐦🔗: https://n.respublicae.eu/EMA_News/status/1603692342283845633