UK – NICE fails to recommend Boehringer Ingelheim and Lilly Alliance’s empagliflozin
In a blow to patients who currently lack recommended treatment options for chronic heart failure with preserved or mildly reduced ejection fraction, Boehringer Ingelheim...
Europe – Review of transparency rules for the EU Clinical Trials Information System (CTIS)
EMA has opened a public consultation to review the transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS) in the European Union...
Europe – Addendum to the guideline on the evaluation of medicinal products indicated for...
This addendum to the Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev 3) has been developed to...
Europe – Global regulators agree on key principles on adapting vaccines to tackle virus...
On 30 June, regulators from around the world discussed emerging evidence to support adaptation of COVID-19 vaccines as the SARS-COV-2 virus continues to evolve...
Europe – European Pharmacopoeia seeking user feedback on use of recombinant factor C for...
General chapter 2.6.32. Test for bacterial endotoxins using recombinant factor C was published in Supplement 10.3 of the European Pharmacopoeia (Ph. Eur.) and came into force on 1 July 2021....
Europe – Regulatory update – EMA encourages companies to submit type I variations for...
The European Medicines Agency (EMA) is advising marketing authorisation holders to submit type IA and type IAIN variations for 2022 no later than Wednesday, 30 November 2022. This...
Europe – First gene therapy to treat haemophilia B
EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Hemgenix (etranacogene dezaparvovec) for the treatment of severe and moderately severe haemophilia...
Europe – Regulatory, industry panels address EU GMP Annex 1 implementation
Pharmaceutical manufacturers in the EU may have to approach the manufacturing of sterile drugs a little differently under the EU’s Annex 1 covering good...
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,...
UK – NICE recommends Vazkepa for patients at risk of stroke and heart attacks...
Vazkepa is a new active substance, made up of a highly purified omega-3 fatty acid and is the first in this class to be...
