USFDA accepts Eisai’s sBLA and grants priority review for approval of LEQEMBITM…
USFDA accepts Eisai's sBLA and grants priority review for approval of LEQEMBITM Alzheimer's treatment
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Browsing Tag
Biogen
FDA accepts NDA and grants priority review of Zuranolone from Sage Therapeutics, Biogen
Zuranolone is being evaluated as a potential 14-day, rapid-acting, once-daily, oral medication to treat major depressive disorder…
Eisai files for approval of Alzheimer’s drug in Japan
The drug, developed in partnership with Biogen, is an antibody that has been shown to remove sticky deposits of a protein called…
Eisai files for approval of Alzheimer’s drug in Europe
The drug, developed in partnership with Biogen, is an antibody that has been shown to remove sticky deposits of a protein called…
Roche’s Alzheimer’s drug fails to meet goal in long awaited trial
The Swiss drugmaker conducted two identically designed studies, each with about 1,000 participants, who were examined and queried…
Biogen raises annual profit forecast for second straight quarter
Data on the drug has been promising and Biogen and Eisai are expected to file for a US approval soon with a decision expected in…
US health regulator extends review of Biogen’s ALS drug
Biogen said it had submitted responses to the FDA's information requests, which the agency said would require additional time for…
Biogen and Eisai amend collaboration agreements on Alzheimer’s disease treatments
Aducanumab collaboration to convert from Eisai sharing of global profits and losses to a global royalty arrangement, effective 1st…
Schneider Electric launches programme to increase access to renewable energy for pharmaceutical…
The collaboration aims to accelerate the adoption of renewable energy and reduce greenhouse gas emissions within the…
Former FDA adviser calls for wider probe into Biogen Alzheimer’s drug approval
Acting FDA Commissioner Janet Woodcock earlier this month asked the Office of the Inspector General at the Department of Health…