European committee takes a second look at Alzheimer’s drug and now says it should be approved
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...
STAT2h
Changing course, European regulators now say Alzheimer’s treatment Leqembi should be approved
Reversing an earlier decision, European regulators recommended that an Alzheimer’s therapy from Eisai and Biogen should be ...
European watchdog partially approves new Alzheimer's drug
Europe's medicines watchdog on Thursday partially approved a marketing request for a long-awaited new treatment for Alzheimer ...
FiercePharma3h
EMA about-faces, backs Eisai and Biogen's Leqembi in restricted Alzheimer's population
Upon reexamination, the European Medicines Agency has made a U-turn on Eisai and Biogen’s Alzheimer’s disease drug Leqembi. | ...
Press Release: Sarclisa recommended for EU approval by the CHMP to treat transplant-ineligible newly diagnosed multiple myeloma
Sarclisa recommended for EU approval by the CHMP to treat transplant-ineligible newly diagnosed multiple myelomaRecommendation based on IMROZ ...
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 ...
Foreign Affairs14h
Europe Must Unlock Its Geoeconomic Power
In a similar manner, member states must now pool their resources to address their shared geoeconomic concerns. To achieve ...
EU drugs regulator recommends Alzheimer's drug from Eisai-Biogen
The European Union's drugs regulator on Thursday said it recommends approval of Eisai and Biogen's Leqembi in patients with ...
precisionmedicineonline2h
EMA's CHMP Now Recommends Approval for Eisai, Biogen's Alzheimer's Drug Leqembi in Europe
The agency had previously recommended against marketing authorization for the Alzheimer's disease but reconsidered after a review.
EU regulator backs Eisai-Biogen Alzheimer's drug after initial rejection
The European Union's drugs regulator on Thursday recommended approval for Eisai and Biogen's Leqembi in some patients with ...
pharmaphorum8d
European Medicines Agency reveals favoured cities for relocation
The European Medicines Agency has revealed a list of five cities that are preferred as its new location by staff after Brexit, following warnings of a public health disaster if EU leaders pick the ...
The Lancet11h
Amyloid-lowering treatment in Alzheimer's disease
We fully endorse the Editorial1 on the negative opinion of the European Medicines Agency of the use of lecanemab for the treatment of early Alzheimer's disease. Investigators from the European ...