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 the drug.

Biogen said Thursday that the drug, known in the U.S. as Leqembi, received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use as a treatment for early Alzheimer’s disease.

The committee had said in July that concerns about the drug’s potential side effects outweigh the impact it has in slowing the fatal, mind-robbing disease. But Japanese drugmaker Eisai asked the committee to reconsider its decision.

Eisai developed Leqembi and is co-marketing it with Cambridge, Massachusetts-based Biogen Inc.

Leqembi clears a sticky brain plaque linked to the disease. A large study has shown that it slowed memory and thinking decline by several months in those who received the treatment compared to those who got a dummy drug.

Ford takes $165M hit on slow recall

Ford Motor Co. will pay a penalty of up to $165 million to the U.S. government for moving too slowly on a recall and failing to give accurate recall information.

The National Highway Traffic Safety Administration said Thursday that the civil penalty is the second-largest in its 54-year history. Only the fine Takata paid for faulty air bag inflators was higher.

The agency said Ford was too slow to recall vehicles with faulty rearview cameras, and it failed to give the agency complete information, which is required by the Federal Motor Vehicle Safety Act.

“Timely and accurate recalls are critical to keeping everyone safe on our roads,” NHTSA Deputy Administrator Sophie Shulman said. “When manufacturers fail to prioritize the safety of the American public and meet their obligations under federal law, NHTSA will hold them accountable.”