USA – FDA seeks feedback on artificial intelligence in drug manufacturing
The US Food and Drug Administration (FDA) is soliciting feedback on how to incorporate artificial intelligence (AI) and advanced manufacturing techniques into the current...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Three new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended three medicines for approval at its January 2024 meeting.
The committee recommended granting a marketing...
Europe – EMA grants AZ’s Vaxzevria COVID-19 vaccine full marketing authorisation
Previously, Vaxzevria was given a conditional Marketing Authorisation (cMA) due to the critical nature of the COVID-19 pandemic, and as further significant evidence of...
Europe – PRAC Strategy on Measuring the Impact of Pharmacovigilance Activities (Revision 2)
Pharmacovigilance activities and the regulatory actions taken by competent authorities based on emerging pharmacovigilance data are designed to lead to changes in knowledge and...
International – WHO proposes updated excipient GMPs in wake of contaminated cough syrup
The World Health Organization (WHO) recently proposed updated guidance to assist pharmaceutical manufacturers in assessing the quality of excipients after child deaths were reported...
USA – FDA warns that emerging Omicron subvariant could make Evusheld obsolete
AstraZeneca’s Covid-19 pre-exposure prophylactic Evusheld has managed to remain relevant for immunocompromised and other patients when many of its therapeutic peers haven’t with each...
UK – Nitrosamines impurities in medicines
The Medicines and Healthcare products Regulatory Agency (MHRA) has assessed the risk of nitrosamine formation or presence during the manufacture of human medicines and...
Europe – ECDC-EMA statement on booster vaccination with Omicron adapted bivalent COVID-19 vaccines
The European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) have issued a joint statement providing updated public health considerations on the...
France – Gustave-Roussy choisit Synapse Medicine pour sécuriser ses prescriptions complexes
VILLEJUIF (Val-de-Marne), BORDEAUX (TICsanté) - Le centre de lutte contre le cancer Gustave-Roussy a noué un partenariat avec l'entreprise bordelaise Synapse Medicine, qui développe...
UK – NICE opts to reject Acorda’s MS drug Fampyra
The National Institute for Health and Care Excellence (NICE) has announced its decision to reject Fampyra – also known as fampridine – for use...
