EMA

Global regulators confirm good safety profile of COVID-19 vaccines

EMA has just endorsed a joint statement on the safety of COVID-19 vaccines issued by the International Coalition of Medicines Regulatory Authorities (ICMRA).

Evidence from more than 13 billion doses of COVID-19 vaccines administered worldwide shows that these vaccines aimed at protecting people from severe outcomes of COVID-19 have a very good safety profile in all age groups, including children and people with underlying medical conditions, immunocompromised patients and pregnant women.

First gene therapy to treat haemophilia B

EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Hemgenix (etranacogene dezaparvovec) for the treatment of severe and moderately severe haemophilia B in adults who do not have factor IX inhibitors (auto-antibodies produced by the immune system which make factor IX medicines less effective).

EMA confirms recommendation to withdraw marketing authorisations for amfepramone medicines

EMA's safety committee (PRAC) has confirmed its recommendation to withdraw the marketing authorisations for amfepramone obesity medicines. This follows a re-examination of its previous recommendation of June 2022, which was requested by the companies that market these medicines.

New vaccine to protect people in the EU and worldwide against dengue

EMA's human medicines committee (CHMP) has adopted a positive opinion for Dengue Tetravalent Vaccine (live, attenuated) Takeda, used to prevent disease caused by dengue virus serotypes 1, 2, 3 and 4 in people from four years of age.

Dengue is a mosquito-borne tropical disease caused by four types of the dengue virus, leading to mild, flu-like symptoms in most people.

Accelerating Clinical Trials in the EU: publication of 2022-2026 workplan

The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published the 2022-2026 workplan of the initiative Accelerating Clinical Trials in the EU (ACT EU).

EMA launches pilot project on analysis of raw data from clinical trials

EMA has launched a pilot project to assess whether the analysis of 'raw data' from clinical trials by regulatory authorities improves the evaluation of marketing authorisation applications (MAAs) for new medicines as well as post-authorisation applications and to explore the practical aspects of the submission and analysis of such data.

Global regulators agree on key principles on adapting vaccines to tackle virus variants

On 30 June, regulators from around the world discussed emerging evidence to support adaptation of COVID-19 vaccines as the SARS-COV-2 virus continues to evolve during a workshop co-chaired by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA).

EMA

More Pharma News ...