Medscape5h
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 ...
STAT7h
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: ...
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 ...
GlobalData on MSN1d
EMA committee rethinks stance and recommends Leqembi for Alzheimer’s disease
Following a re-evaluation, the EMA has recommended Eisai and Biogen’s Alzheimer’s therapy Leqembi for a subgroup of patients.
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 ...
FiercePharma1d
EMA changes tune, endorses 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. | ...
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 ...
STAT1d
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 ...
The Pharma Letter5h
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 ...
FiercePharma7h
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.
Ticker: Biogen Alzheimer’s drug gets second look in EU; Ford takes $165M hit on slow recall
A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting ...
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 ...