USA – FDA withdraws pre-term birth drug Makena
Two-and-a-half years after it first proposed doing so, the US Food and Drug Administration (FDA) has made a final decision to immediately withdraw Makena...
UK – AbbVie’s Rinvoq recommended by NICE for Crohn’s disease
The authorisation, which makes Rinvoq the first oral Janus Kinase (JAK) inhibitor available for this indication in England and Wales, specifically applies to patients...
Europe – EMA alerts EU patients and healthcare professionals to reports of falsified Ozempic...
The European Medicines Agency has been notified by relevant national competent authorities that pre-filled pens falsely labelled as the diabetes medicine Ozempic (semaglutide, 1 mg, solution...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Nine new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its May 2022 meeting.
A recommendation for marketing authorisation was adopted...
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...
International – WHO launches R&D efforts to identify pathogens that could cause future pandemics
Disease X represents an unknown pathogen that could have the potential to cause the next global pandemic.
Discussions began on Friday 18 November and WHO...
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...
USA – Experts call for federal incentives to promote clinical trial diversity
A combination of federal incentives and regulations, similar to the approach used to increase pediatric drug development, is needed to increase the diversity of...
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 – EMA recommends restricting use of cancer medicine Rubraca
EMA’s human medicines committee, CHMP, has recommended that Rubraca (rucaparib camsylate) should no longer be used as third-line treatment for cancers of the ovary, fallopian...
