UK – NICE approval for Janssen’s Darzalex combination
Recommendation concerns routine use across the NHS as therapy for multiple myeloma
The Janssen Pharmaceutical Companies of Johnson & Johnson have announced that the National...
UK – NICE recommends Pfizer’s rimegepant for preventing episodic migraine attacks
The National Institute for Care and Excellence (NICE) has announced that it has recommended an oral treatment for the prevention of episodic migraines for...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 March 2024
EMA’s safety committee (PRAC) concluded that there was insufficient evidence to establish a causal association between the COVID-19 vaccines Comirnaty and Spikevax and cases of...
Europe – Evaluation of medicinal products indicated for treatment of bacterial infections
This guideline merges, revises and adds to the guidance previously included in the Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 Rev...
Europe – EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna
EMA’s human medicines committee (CHMP) has recommended not renewing the conditional marketing authorisation for Translarna (ataluren), a medicine for treating patients with Duchenne muscular dystrophy. Translarna...
UK – NICE nod for AstraZeneca’s Lynparza
Therapy treats patients with specific types of ovarian, fallopian tube or primary peritoneal cancer
The National Institute for Health and Care Excellence (NICE) has recommended...
Europe – Review: real-world data studies
Sustainable framework to support scientific evaluations in the EU
By complementing existing evidence, use of real-world data (RWD) and real-world evidence (RWE) can speed up...
UK – Pfizer’s Talzenna recommended by NICE for advanced breast cancer
Patients eligible for the PARP inhibitor will have previously been treated with anthracycline or taxane chemotherapy, or both, unless these treatments are not suitable.
Additionally,...
Europe – New recommendations to strengthen supply chains of critical medicines
These recommendations have been developed by EMA’s Medicines Shortages Steering Group (MSSG) and will facilitate the availability and supply of critical human medicines for which vulnerabilities...
Europe – Regulatory information – adjusted fees for pharmacovigilance applications from 3 October 2022
Pharmacovigilance fees payable to the European Medicines Agency by applicants and marketing authorisation holders increase by 5.6% as of 3 October 2022, to reflect the inflation rate...
