Europe – First gene therapy to treat severe haemophilia A

EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Roctavian (valoctocogene roxaparvovec) for the treatment of severe haemophilia A in adults who...

Europe – EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17

EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Nuvaxovid to include use in adolescents aged 12 to 17...

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...
NICE rejects Novartis’ CAR-T Kymriah for adult lymphoma

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...

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