FiercePharma2d
EU regulators endorse meds from BMS, J&J, Eisai and more—plus a clutch of biosims
Now, it's up to the European Commission to confirm those potential green lights in the coming weeks and months.
STAT2d
Pharmalittle: We’re reading about an Alzheimer’s drug about-face, Bavarian Nordic’s views on Trump, and more
Reversing an earlier decision, European regulators recommended that the Alzheimer’s therapy Leqembi should be approved ...
emjreviews.com1d
EU Rejects Majority of US Fast-Tracked Cancer Drugs
A new study reveals that more than half of cancer drugs approved by the FDA under accelerated pathways are not authorized in ...
Eisai Receives Positive Opinion from the CHMP in the European Union for Lecanemab in Early Alzheimer’s Disease
1. About lecanemab (generic name, brand name: Leqembi®) Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal ...
devdiscourse5d
Aurobindo Pharma's Triumph: EU GMP Certification for Biosimilars
Aurobindo Pharma's subsidiary, CuraTeQ Biologics, has received a GMP certificate from the European Medicines Agency for its ...