International – EMA-FDA parallel scientific advice program has ‘limited’ uptake
A review of the last five years of the Parallel Scientific Advice (PSA) program between the US Food and Drug Administration (FDA) and the...
UK – Gilead’s CAR-T cell therapy recommended by NICE for lymphoma
Specifically, the therapy is now recommended for adult patients with diffuse large B-cell lymphoma (DLBCL) or primary mediastinal large B-cell lymphoma (PMBCL) who have...
USA – FDA grants fast track designation to AC Immune’s Alzheimer’s disease vaccine
The candidate, ACI-24.060, will now benefit from the FDA’s fast track process, which is designed to improve the efficiency of product development and accelerate...
USA – FDA finalizes guidance on cannabis clinical research
The US Food and Drug Administration has finalized a 2020 draft guidance outlining how sponsors and investigators can conduct clinical trials for certain drugs...
International – Pharma groups question enhanced approach in Q14, call for more alignment between...
Pharmaceutical industry groups praised certain aspects of the International Council for Harmonisation (ICH) draft Q14 and Q2(R2) guidelines yet had questions on how enhanced...
International – WHO releases key regulatory considerations on AI for health
The World Health Organization (WHO) has published new key regulatory considerations on artificial intelligence (AI) for health to emphasise the importance of establishing the...
Europe – EFPIA: EU pharma manufacturing would ‘grind to a halt’ under proposed PFAS...
The European Union’s proposed restriction on the use of per- and polyfluoroalkyl substances (PFAS), also known as “forever chemicals,” would have grave implications on...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 – 12...
Alignment of dose recommendations for Janus kinase (JAK) inhibitors in patients with certain risk factors
EMA’s safety committee, PRAC has further reviewed measures to minimise the risk of serious...
Europe – EU report examines barriers to combined studies of drugs, IVDs, and devices
A lack of alignment between the Clinical Trials Regulation (CTR) the In Vitro Diagnostic Medical Device Regulation (IVDR), and the Medical Device Regulations (MDR)...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June 2024
Review of painkiller metamizole started
Review will look into risk of agranulocytosis, a sudden drop in white blood cells that can lead to serious infections,...
