Switzerland – New COVID-19 vaccine successfully tested

Rocketvax and researchers at the University of Basel have linked up to develop a new approach for a COVID-19 vaccine. Researchers led by Professor Thomas...

UK – NICE recommends Pfizer’s rimegepant for preventing episodic migraine attacks

The National Institute for Care and Excellence (NICE) has announced that it has recommended an oral treatment for the prevention of episodic migraines for...

Europe – Global regulators agree on way forward to adapt COVID-19 vaccines to emerging...

International regulators have published a report today highlighting the outcomes of their discussions on COVID-19 vaccines and the need for and strategy to update their composition...

Europe – EU regulator recommends revoking approval for Novartis’ sickle cell disease drug

The European Medicines Agency’s (EMA) human medicines committee has recommended revoking the conditional marketing authorisation for Novartis’ sickle cell disease (SCD) drug Adakveo (crizanlizumab). The...

Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...

Two new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended two medicines for approval at its May 2023 meeting. The committee recommended granting a marketing...

Europe – EMA recommends revocation of authorisation for sickle cell disease medicine Adakveo

EMA’s human medicines committee (CHMP) has recommended revoking the marketing authorisation for Adakveo (crizanlizumab), a medicine for preventing painful crises (called vaso-occlusive crises) in patients aged...
Advice for Management of Clinical trials in relation to Coronavirus

UK – SKYCovion COVID-19 vaccine authorised by MHRA

SKYCovion, the COVID-19 vaccine developed by SK Chemicals, has today been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA). It becomes the 8th...
Advice for Management of Clinical trials in relation to Coronavirus

UK – MHRA announces new recognition routes to facilitate safe access to new medicines...

New regulatory recognition routes for medicines will be established using approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States,...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – Regulatory approval of Pfizer/BioNTech vaccine for COVID-19

There are four presentations of the original COVID-19 Vaccine Pfizer/BioNTech authorised for use in Great Britain, three of which are currently available and all...

UK – Bayer’s Nubeqa combination recommended by NICE to treat metastatic prostate cance

The final draft guidance from NICE specifically recommends Nubeqa tablets in combination with androgen deprivation therapy (ADT) and docetaxel. The decision follows the Medicines and...

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