The agency recommended a total of 11 drugs at its July meeting, including five orphan drugs.
The European Medicines Agency announced on July 21, 2017 that its Committee for Medicinal Products for Human Use (CHMP) recommended approval of 11 medicines at its July meeting. The approved medicines include five orphan drugs and included treatments for multiple types of cancer.
The orphan drugs the committee recommended for authorization are:
CHMP also gave positive opinions to Dupixent (dupilumab), for the treatment of atopic dermatitis; Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide), for the treatment of HIV infection; and Tecentriq (atezolizumab), for the treatment of locally advanced or metastatic urothelial carcinoma and of non-small cell lung cancer. Generic drugs Entecavir Accord (entecavir) and Entecavir Mylan (entecavir), both for the treatment of chronic hepatitis B; and Lacosamide Accord (lacosamide), for the treatment of epilepsy, were also given a positive opinion.
Two drugs received a negative opinion: Fanaptum (iloperidone), for the treatment of schizophrenia, and Onzeald (etirinotecan pegol), for the treatment of breast cancer with brain metastases.
Source: EMA
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
AES Clean Technology Launches Next-Generation OSM Utility Solution for Cleanrooms at INTERPHEX 2025
April 2nd 2025Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.