Europe – Global regulators strengthen efforts to ensure continuous availability of safe and high-quality...
On 20 July 2023, a virtual workshop was held to discuss progress made in the development of a PQ KMS. The workshop was jointly organised by...
Europe – EMA update on shortages of antibiotics in the EU
EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) met on Thursday to discuss the progress made and to agree on the next...
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...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Four new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended four medicines for approval in the European Union (EU) at its April 2022...
UK – European Commission Decision Reliance Procedure (ECDRP) extension
The European Commission Decision Reliance Procedure (ECDRP) has been extended to 31 December 2023. From 1 January 2024 a new international recognition framework will be in...
UK – NICE gives green light for MSD’s Keytruda
The decision is the first verdict based on data from a wider immunotherapy ‘basket’ study
MSD has revealed that the National Institute for Health and...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 May 2022
At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
14 new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended 14 medicines for approval at its July 2023 meeting.
The CHMP recommended granting a marketing authorisation for Abrysvo (bivalent, recombinant),...
Europe – Human medicines: highlights of 2023
The Agency recommended two vaccines to protect against lower respiratory tract disease caused by respiratory syncytial virus (RSV), and the first advanced therapy medicinal product using...
UK – NICE draft final guidance for Gedeon Richter UK’s new uterine fibroids treatment
Around 4,500 people in the UK will be eligible for a new oral treatment for uterine fibroids. It follows the National Institute for Health...
