EU CHMP To Review July Rejection Of Drugs For Schizophrenia, Metastatic Breast Cancer
Executive Summary
The EMA’s CHMP is this week hearing oral evidence on two products it turned down in July – for schizophrenia and metastatic breast cancer – as well as on other drugs for multiple myeloma and multiple sclerosis.
You may also be interested in...
Roche’s Hemlibra Looking For CHMP Green Light, Crunch Time for Santhera DMD Hopeful
The first meeting this year of the European Medicines Agency’s key scientific committee, the CHMP, is under way in London, with a number of new drugs up for a marketing authorization recommendation.
EU CHMP OKs New Treatments For MS, Esophagitis, CMV, Hemophilia – & First Biosimilar Avastin
The EMA’s scientific committee, the CHMP, has given the green light to new treatments for multiple sclerosis, eosinophilic esophagitis, CMV, hemophilia A, and vaginal atrophy, as well as the EU’s first biosimilar version of Roche’s Avastin. The committee upheld two earlier negative opinions, and two products have been withdrawn from the assessment process.
CHMP OKs Drugs For MS, Esophagitis, CMV & Hemophilia – And First EU Biosimilar Avastin
At its November meeting, the CHMP finally OKd Roche's Ocrevus for multiple sclerosis and gave the green light to new drugs for eosinophilic esophagitis, CMV, hemophilia A, and vaginal atrophy, as well as Amgen’s Mvasi, the first EU biosimilar version of Roche’s Avastin. The committee upheld two earlier negative opinions, and two products were withdrawn from the assessment process.