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 ...
STAT1h
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: ...
FiercePharma1h
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 ...
Couple fighting Alzheimer’s become advocates for a cure
Alzheimer’s changed the couple’s routine, but not their fight to keep going. Together, David and Pamela are awareness advocates for the Alzheimer’s Association. They’ve met with representatives on ...
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 ...
'We are very hopeful' | New nasal spray could delay Alzheimer's by years, researchers say
Researchers at Texas A&M University have developed a nasal spray shown to delay disease progression in animals -- fueling ...
BioPharma Dive18h
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.
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 ...
GlobalData on MSN20h
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 ...