UK – J&J’s Tecvayli recommended by NICE to treat relapsed and refractory multiple myeloma
The final draft guidance specifically applies to patients who have received at least three prior treatments, have progressed on their last treatment, and would...
Europe – Development and manufacture of oligonucleotides – Scientific guideline
This guideline addresses specific aspects regarding the manufacturing process, characterisation, specifications and analytical control for synthetic oligonucleotides which are not covered in the Guideline...
UK – NICE recommends Accord’s oral hormone therapy Orgovyx for advanced prostate cancer
The androgen deprivation therapy (ADT), which has been specifically recommended for those with hormone-sensitive cases of the disease, is now the first oral treatment...
Europe – EMA confirms its recommendation to update the antigenic composition of authorised COVID-19...
In April 2024, the European Medicines Agency (EMA) issued a recommendation to change the antigenic composition of authorised COVID-19 vaccines for use during the...
Switzerland – Déclarations d’effets indésirables présumés de vaccins contre le COVID-19 évaluées en Suisse
Depuis le rapport standard final sur les déclarations d’effets indésirables présumés des vaccins COVID-19 évaluées en Suisse de fin février 2023, 720 déclarations ont été évaluées....
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July 2024
PRAC elects new chair
The July 2024 meeting of EMA’s safety committee (PRAC) was the last plenary meeting chaired by Sabine Straus, who retires as Chair after...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
EMA’s human medicines committee (CHMP) recommended ten medicines for approval at its June 2024 meeting.
The committee recommended granting a marketing authorisation for Balversa (erdafitinib), for the treatment of adult...
Europe – EMA proposes revamping COVID-19 vaccine guidance for the post-pandemic era
The European Medicines Agency (EMA) is proposing to update its COVID-19 guidances to reflect new developments in the non-clinical and clinical development areas. It...
Europe – Commission authorises Chikungunya vaccine and funds new mosquito eradication programme
The Commission has today authorised the first-ever vaccine against Chikungunya virus - a disease transmitted by infected mosquitoes.
While Chikungunya is not endemic in the EU, the...
Europe – Core summary of product characteristics for human plasma-derived and recombinant coagulation factor...
This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for human plasma derived and recombinant coagulation factor IX products, which are...
