Europe – EMA recommends Valneva’s COVID-19 vaccine for authorisation in the EU
EMA has recommended granting a marketing authorisation for COVID-19 Vaccine (inactivated, adjuvanted) Valneva for use in the primary vaccination of people from 18 to 50 years...
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...
USA – Euro Roundup: EFPIA ‘deeply disappointed’ by COVID vaccine TRIPS waiver
The World Trade Organization’s (WTO) agreement to a partial patent waiver for COVID-19 vaccines “sends a dangerous signal” to the pharmaceutical industry and all...
Europe – Global regulators work towards strengthening collaboration on observational research beyond COVID-19 pandemic
Lessons learned from international collaboration on observational research during the pandemic were highlighted during the latest global regulatory workshop on COVID-19 observational studies and...
Europe – EMA Management Board: highlights of June 2022 meeting
At its 16 June 2022 meeting in Amsterdam, the European Medicines Agency's (EMA) Management Board elected Christelle Ratignier-Carbonneil as vice-Chair of the Board for a three-year...
Europe – Start of rolling review for adapted Spikevax COVID-19 vaccine
EMA has started a rolling review for a version of Spikevax adapted to provide better protection against specific variants of SARS-CoV-2, the virus that...
UK – NICE recommends Eli Lilly’s breast cancer therapy
Eli Lilly has announced that Verzenios – also known as abemaciclib – in combination with endocrine therapy, has been recommended by the National Institute...
UK – Genedrive genetic variant test for infants evaluated by NICE
Genedrive – the near patient molecular diagnostics company – has revealed that the National Institute for Health and Care Excellence (NICE) has started an...
UK – MHRA joins international partnerships to set global standards for medicines and medical...
The UK is set to play a greater international role in making sure medicines and medical devices are regulated safely and efficiently worldwide, the...
Europe – Start of rolling review for adapted Comirnaty COVID-19 vaccine
EMA has started a rolling review for a version of Comirnaty adapted to provide better protection against a specific variant or variants of SARS-CoV-2,...
