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regulatory decisions

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AbbVie submits migraine prevention drug to EMA for marketing authorisation

If approved, atogepant would be the first daily oral CGRP receptor antagonist migraine treatment for adults in Europe

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EMA grants Bavarian Nordic access to PRIME scheme for RSV vaccine candidate

It is estimated that infections caused by this respiratory virus lead to over 175,000 hospitalisations and 14,0000 deaths in older people in the US each year

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AstraZeneca’s COVID-19 vaccine receives EMA approval for use as third-dose booster

Vaxzevria is a ‘viral vector’ vaccine, a technology that is also used to create vaccines for other infectious diseases like flu, HIV and Ebola

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Positive CHMP opinion issued for PTC Therapeutics’ Upstaza

The treatment for AADC will be the first marketed gene therapy to be administered directly into the brain

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EMA accepts Valneva’s marketing authorisation application for COVID-19 vaccine

The vaccine is currently the only inactivated, whole virus adjuvanted candidate in clinical trials in Europe

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Biogen retracts EMA application for Alzheimer’s drug Aduhelm

The application was pulled after the CHMP said the data provided was not enough to support a marketing authorisation

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EMA and ECDC publish advice on fourth doses of mRNA COVID-19 vaccines

The regulators have concluded that there is not enough supporting evidence for an immediate fourth dose

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EMA establishes DARWIN EU Coordination Centre

The new centre will give the EMA and other EU member states access to reliable, real-world evidence for EU medicine assessments

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Pfizer’s Paxlovid receives positive opinion from CHMP

If authorised, the drug would be the first COVID-19 oral treatment recommended in the EU

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EMA proposes EU clinical trial reforms

The ACT EU paper provides a list of regulatory network objectives, priorities and governance strategies for 2022-2023

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Gilead’s Trodelvy approved for triple-negative breast cancer in Europe

European patients with metastatic triple-negative breast cancer can now receive the antibody-drug conjugate as second-line monotherapy

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Gilead’s Trodelvy set for EU approval in breast cancer

The positive opinion from EMA’s CHMP means Trodelvy could be available as second-line treatment for unresectable or metastatic breast cancer before the end of the year

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