Europe – Clinical investigation of recombinant and human plasma-derived factor IX products – Scientific...
This guideline describes the information to be documented when an application for a marketing authorisation for recombinant or human plasma-derived factor IX products is made for use...
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...
International – ICH adopts Q9 guidelines on quality risk management
The International Council for Harmonisation (ICH) has adopted a revised version of its Q9 guideline that aims to improve current quality risk management (QRM)...
USA – FDA Authorizes First Over-the-Counter At-Home Test to Detect Both Influenza and COVID-19...
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) at-home diagnostic test that can differentiate and detect...
France – La HAS actualise la doctrine vaccinale de lutte contre les orthopoxvirus
Les orthopoxvirus constituent une famille de virus à laquelle appartiennent la variole, mais aussi la vaccine et le mpox (nouveau nom du virus monkeypox). Comme...
USA – Uptake of biosimilars on the rise in the US, but number of...
Fewer biosimilars have been marketed in the United States, compared with Germany and Switzerland, and prices are significantly higher in the US. However, biosimilars...
