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)...
UK – NICE recommends wider use of statins to cut risk of heart attack...
Up until now, NICE has recommended that those with a 10% or higher risk over ten years of a cardiovascular event should be offered...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Seven new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its December 2023 meeting.
The committee recommended granting a conditional...
Europe – Guideline on clinical investigation of medicinal products in the treatment or prevention...
This guideline intends to address the current EU regulatory position on the main topics of the clinical development of new medicinal products in the...
Europe – EU recommendations for 2024/2025 seasonal flu vaccine composition
EMA has issued recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn...
UK – Sobi receives NICE recommendation for Zynlonta in two non-Hodgkin lymphomas
The CD19-directed antibody-drug conjugate (ADC) has specifically been recommended for use in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or high-grade...
Europe – ACT EU: creating a better environment for clinical trials through collaboration
The Accelerating Clinical Trials in the EU (ACT EU) initiative is today organising the kick-off workshop for a new multi-stakeholder platform to improve clinical trials in the European Union (EU)....
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...
Europe – Guidance for industry to prevent and mitigate medicine shortages
EMA has published recommendations for industry on good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact .
Medicine...
UK – Novartis’ Cosentyx recommended by NICE for hidradenitis suppurativa
The recommendation, which makes Cosentyx the first biologic treatment for HS since 2016, specifically applies to patients who have had an inadequate response to...
