EU regulator reiterates positive recommendation for Eisai-Biogen's Alzheimer's drug
The European Union's medicines regulator on Friday reiterated its positive recommendation for Eisai and Biogen's Alzheimer's drug, Leqembi, after concluding a safety review. The European Medicines Agency (EMA) in late January said the European Commission had requested a review of additional safety information for the drug,
Biogen, Eisai Continue Leqembi’s European Rally as CHMP Reaffirms Positive Opinion
Leqembi’s application now moves forward to the European Commission, which will issue a formal verdict for the injection that will apply to all EU member states as well as Norway, Liechtenstein and Iceland.
Lecanemab: European drug agency upholds decision to recommend Alzheimer’s drug
The European Medicines Association (EMA) has upheld its decision to recommend the Alzheimer’s drug lecanemab despite concerns that any clinical benefits are small and there is a risk of brain swelling and microbleeds.
Biogen, Eisai: CHMP Reaffirms Backing of Leqembi Alzheimer's Drug
The companies on Friday said the European Commission, which had asked the panel to consider information on the safety of Leqembi that became available after it adopted a positive opinion in November,
EU regulator completes safety review of Eisai-Biogen's Alzheimer's drug without changes
The European Union's drugs regulator said on Friday it concluded a review into the safety of Eisai and Biogen's Alzheimer's drug Leqembi without finding the need for any changes to the drug's status.
The European Medicines Agency EMA has not 'admitted' that mRNA vaccines are 'experimental'
A false claim is circulating online that the European Medicines Agency (EMA) has acknowledged that mRNA vaccines have not ...
Vietnam Investment Review on MSN6h
European medicine standards growing presence in Vietnam
Following a year of strategic expansion, European medicine-related companies are advancing their operations in Vietnam.
The Pharma Letter3d
Three novel medicines recommended for approval by EMA/CHMP
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended three novel medicines for approval at its ...
Healio3d
European Medicines Agency recommends ‘landmark’ gene therapy for epidermolysis bullosa
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended the approval of Vyjuvek for the ...
Medical Xpress12d
European study highlights inequalities in diagnosis and treatment of biliary tract cancer
One of the main challenges identified by the research was that, although the European Medicines Agency (EMA) approves new ...
Drug companies and Minister agree medicines need to be available to patients more quickly
Patients should have faster access to newly developed drugs and medicines and the Government is prepared to adopt new ...
Crain's Chicago Business3d
Europe poised to OK another use for AbbVie's Rinvoq
Right now, Rinvoq is approved in the European Union and the U.S. for the treatment of adults with radiographic axial ...