EISAI CO

The EMA partially approved Leqembi for mild cognitive impairment or mild dementia due to Alzheimer’s, limited to patients with one or no ApoE4 gene copy, to minimize brain bleeding risks. Leqembi, developed by Biogen and Eisai, targets early Alzheimer’s stages by clearing harmful proteins and has shown to reduce cognitive decline by 25%.

Eisai and Biogen announce CHMP positive opinion for lecanemab, an Aβ monoclonal antibody for early Alzheimer’s disease, with the European Commission expected to make a final decision within 67 days.

EMA recommends EU approval of Leqembi, the first Alzheimer’s treatment that slows disease progression, for patients with one or no ApoE4 gene copy. The treatment, made by Eisai and Biogen, was previously rejected due to high side effect risks.

EU drugs regulator recommends Eisai and Biogen’s Leqembi for early Alzheimer’s patients with one or no ApoE4 gene variant, reversing earlier rejection due to brain swelling risks.

CHMP recommends EU approval of lecanemab for early Alzheimer’s in ApoE ε4 heterozygotes or non-carriers, following Eisai’s re-examination request. Decision expected within 67 days.

EMA approves Eisai/Biogen's Alzheimer's drug Leqembi after initial rejection, with recommendations for initial generic screening and ongoing safety monitoring.

Merck & Co. acquires LaNova Medicines' LM-299 cancer therapy for $588 million, aiming to bolster its cancer immunotherapy portfolio against emerging PD-1 and VEGF bispecific therapies, which pose a threat to its Keytruda drug. The deal reflects Merck's strategic interest in advancing dual-target cancer treatments, as Keytruda faces potential patent expiration and limited durable response rates.

EMA now supports Leqembi approval in Europe for mild Alzheimer’s patients with low ARIA risk, reversing earlier safety concerns. This decision could boost sales, with 20% from Europe, despite potential reimbursement hurdles and lower pricing.

The European Medicines Agency's Committee for Medicinal Products for Human Use now recommends approval of lecanemab, an Alzheimer’s treatment, after initially rejecting it due to concerns over side effects. Developed by Eisai and co-marketed with Biogen, lecanemab clears brain plaque and has shown to slow memory decline in a large study. Separately, Ford Motor Co. faces a $165 million penalty from the U.S. government for slow recall response and inaccurate information on faulty rearview cameras.