Medscape3h
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 ...
STAT5h
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: ...
FiercePharma6h
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.
Benzinga.com8h
Biogen Unusual Options Activity
Biogen's newer products include Spinraza (SMA, with partner Ionis), Leqembi (Alzheimers, with partner Eisai), Skyclarys ...
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 ...
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 ...
BioPharma Dive22h
Eisai wins over European regulators on Alzheimer’s drug Leqembi
A key regulatory committee sided against the drug this summer. But an appeal from Eisai appears to have worked, teeing Leqembi up for authorization in a major market.
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 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 ...
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 ...
EU regulator backs Eisai-Biogen Alzheimer's drug after initial rejection
The European Union's drugs regulator on Thursday recommended approval of Eisai and Biogen's Leqembi for some patients with ...
Biogen’s stock rises after E.U. regulator reverses negative view of Alzheimer’s drug
Biogen’s stock rose 1% Thursday, after Europe’s pharmaceutical regulator issued a positive opinion on the Alzheimer’s disease ...