Europe – First therapy to treat rare genetic nervous system disorder AADC deficiency
EMA has recommended granting a marketing authorisation in the European Union (EU) for Upstaza (eladocagene exuparvovec), a therapy for the treatment of adult and paediatric patients...
International – ICH M13A BE testing guideline expected to be adopted this summer
The International Council for Harmonisation (ICH) is expected to adopt its M13A guideline on bioequivalence (BE) testing of immediate-release (IR) solid oral dosage form...
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...
International – WHO recommends Veklury for high-risk patients
The World Health Organisation (WHO) has recommended Veklury (remdesivir) for the treatment of patients with non-severe COVID-19 who are at the highest risk 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....
USA – FDA officials tout steady growth in biosimilar program, enhancements under FDORA
US Food and Drug Administration (FDA) officials touted “steady growth” in the total number of biosimilar products since the program’s inception, with 40 approvals...
USA – FDA revises guidance on delaying, denying, limiting or refusing an inspection
On Dec. 15, 2022, the FDA released for public comment Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection Revision 1....
Europe – European Commission proposes framework for joint clinical assessments
The European Commission has proposed a framework for joint clinical assessments (JCA) as part of its effort to implement the EU health technology assessment...
International – ICH details milestones reached on guidelines after Athens meeting
The International Council for Harmonisation (ICH) announced it has reached several milestones over the past year, including advancing guidelines on validating analytical procedures for...
Europe – Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for...
The assessment report of the CHMP’s Article 5(3) of Regulation (EC) No 726/2004 opinion on nitrosamine impurities in human medicinal products provides general guidance...
