Eisai and Biogen have been unable to persuade the medicines regulator in Australia to approve their Alzheimer's disease ...

The Therapeutic Goods Administration (TGA) of Australia has declined the approval of Leqembi (lecanemab) as a treatment for ...

In October 2024, the TGA made the decision not to register lecanemab (LEQEMBI) on the Australian Register of Therapeutic Goods (ARTG) for the ...

The first development is the publication of a new book, Doctored, by American investigative journalist Charles Piller, which ...

Australia's Therapeutic Goods Administration (TGA) has said it won't approve Eisai and Biogen's Alzheimer's disease therapy Leqembi, saying its efficacy does not outweigh its risks. Explaining its ...

BioArctic AB's (publ) (NASDAQ: BIOA B) (STOCKHOLM: BIOA B) partner Eisai announced today that the Therapeutic Goods Administration (TGA) ...

While Leqembi sales performed well outside the U.S. and Skyclarys is set to grow internationally, Medicare Part D changes will hit its U.S. sales, reducing revenue by about $15–$30 million.

However, in July 2023, new dementia drug Leqembi (lecanemab) received full approval from the Food and Drug Administration (FDA) on the basis of an 18-month, double-blind, phase 3 clinical trial ...

Key contributors included LEQEMBI with a 28.1 billion yen increase, Lenvima with 24.9 billion yen growth, and Dayvigo up by 9.3 billion yen. Naito emphasized significant milestones for LEQEMBI ...

The milestone was reached as sales of Leqembi reached €200 million in Eisai fiscal year 2024 (April 2024 - Match 2025). The event entitles BioArctic to a €10 million payment. Leqembi is the ...