CHMP Recommended Marketing Authorization for 81 Medicines in 2013
A total of 81 medicines for human use were recommended for?marketing authorization by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), compared with 57 in 2012, according to EMA?s 2013 annual report.
Euro Agency Publishes Annual Report
A total of 81 medicines for human use were recommended for marketing authorization by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), compared with 57 in 2012, according to EMA’s 2013 annual report.
The number of medicines containing a new active substance has continuously increased for the past three years, while the number of generics is stable compared with 2012 but generally decreasing over the last few years, noted the report. Two new advanced-therapy medicinal products (ATMPs) were recommended for approval in 2013, bringing to four the total number of ATMPs recommended for approval by the CHMP since the legislation on advanced therapies was introduced.
The number of recommendations for approval of medicines intended for the treatment of rare diseases is steadily growing, with 11 orphan medicines recommended in 2013 compared with eight in 2012 and four in 2011. Last year also saw the first two positive opinions for marketing authorizations of biosimilar monoclonal antibodies, successfully applying the biosimilar concept to such structurally complex substances, the authors wrote.
Among the key projects highlighted in the document are the plans to publish and give access to clinical trial data submitted to the agency as part of a marketing authorization application, the stronger interaction with health-technology assessment bodies to facilitate patients’ access to medicines, the agency’s pharmacovigilance activities, and the reorganization of the EMA and the implementation of new legislation.
The full report can be found here.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.
