ENDPOINTS NEWS8m
Eu­ro­pean drug reg­u­la­tors of­fer wave of pos­i­tive rec­om­men­da­tions fol­low­ing Leqem­bi re­ver­sal
EMA's human medicines committee issued positive recommendations for multiple drugs, including Merck's Keytruda and InflaRx's ...
The Pharma Letter55m
EMA/CHMP November recommendations include Leqembi U-turn
The European Medicines Agency’s (EMA) human medicines committee (CHMP) made a number of recommendations at its November ...
Medscape1h
Leqembi Okayed for Subset of Early Alzheimer’s Patients
The European Medicines Agency re-examined clinical data of a subset of patients with one or no copies of the APOE4 gene ...
Biogen Partner Eisai Gets Positive CHMP Nod for Leqembi in Europe
The CHMP renders a positive opinion recommending approval for BIIB and Eisai's Leqembi for treating early Alzheimer's disease ...
STAT2h
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 ...
STAT3h
CAR-T promising for autoimmune disease while perhaps preserving fertility
Why one trial participant's healthy birth after her CAR-T treatment for lupus is catching resesarchers' attention: ...
FiercePharma3h
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.
European regulators green light new Alzheimer's drug after first rejecting it
European regulators initially said in July that the drug's benefits did not outweigh its risks.View on euronews ...
JCN Newswire12h
Eisai Receives Positive Opinion from the CHMP in the European Union for Lecanemab in Early Alzheimer's Disease
Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble ...
EU regulator reverses decision to block Alzheimer's drug lecanemab
The European Union's drugs regulator reversed its decision to block the Alzheimer's drug lecanemab, a treatment aimed at ...
Biogen up 5% after EMA recommends Leqembi for early Alzheimer’s disease
EST Biogen (BIIB) up 5% after EMA recommends Leqembi for early Alzheimer’s disease Published first on TheFly – the ultimate ...
EMA recommends Leqembi for treatment of early Alzheimer’s disease
After re-examining its initial opinion, EMA’s human medicines committee, or CHMP, has recommended granting a marketing authorisation to Leqembi for treating mild cognitive impairment or mild dementia ...