UK – COVID-19 vaccines safe for pregnant women

The data revealed evidence of high levels of protection against SARS-CoV-2 infection in pregnant women after COVID-19 vaccination and evidence that vaccination induces higher...

USA – First trial of a vaccine against Alzheimer’s launches

For some time, researchers have looked to the brain's immune system as a key factor in the development of Alzheimer’s disease. Now, after years...
Nitrosamine contamination: new web page on EDQM response

Europe – Évolution des délais de traitement des demandes de CEP par l’EDQM

Depuis le 1er octobre 2021, la Direction européenne de la qualité du médicament & soins de santé (EDQM) utilise un nouvel outil informatique pour gérer les demandes...

Europe – Comirnaty COVID-19 vaccine: EMA recommends approval for children aged 5 to 11

EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use in children aged 5 to 11....

Europe – EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca

EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by AstraZeneca and Oxford University. The assessment of the vaccine, known as...

Europe – EMA receives application for conditional marketing authorisation of COVID-19 Vaccine Janssen

EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by Janssen-Cilag International N.V. EMA’s human medicines committee (CHMP) will assess the...

Europe – EMA starts rolling review of Janssen’s COVID-19 vaccine Ad26.COV2.S

EMA’s human medicines committee (CHMP) has started a rolling review of Ad26.COV2.S, a COVID-19 vaccine from Janssen-Cilag International N.V. The CHMP’s decision to start the rolling review is...

UK – NICE approves hormone drug which could prevent 1,200 miscarriages each year

NICE has issued an update to its guidance on threatened miscarriage which details that certain women can take progesterone to help prevent pregnancy loss....

Europe – A vision for use of real-world evidence in EU medicines regulation

Enabling the use of real-world evidence (RWE) and establishing its value for regulatory decision-making on the development, authorisation and supervision of medicines in Europe...

USA – FDA suggests alternative approaches for nitrosamine risk assessments

The US Food and Drug Administration (FDA) has suggested that manufacturers consider using certain antioxidants or excipients, such as sodium carbonate, to their drug...

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