
Business Apr 9, 2022
Japan's Eisai still seeking accelerated U.S. review of Alzheimer's drug
The firm said it plans to seek a quick approval even after the Medicare health plan decided to limit coverage of medicines approved in that manner.
Japan's Eisai still seeking accelerated U.S. review of Alzheimer's drug
The firm said it plans to seek a quick approval even after the Medicare health plan decided to limit coverage of medicines approved in that manner.
Biogen stung as U.S. limits coverage of Alzheimer’s therapy
Private insurers in the U.S. have mostly declined to cover Aduhelm, saying they need more proof of its efficacy and that benefits outweigh risks like brain swelling.
A health ministry council said "it is difficult for now to explicitly confirm the effectiveness" of aducanumab, citing the lack of consistent results in overseas clinical trials.
Japanese pharmaceutical group warns of 'drug lag' as foreign firms skip domestic market
Low prices are discouraging foreign firms from seeking approval for new drugs in the country, the leader of the Japan Pharmaceutical Manufacturers Association said.
Eisai pushes second Alzheimer's drug despite call to probe U.S. approval of first
The U.S. Food and Drug Administration’s June approval of Aduhelm caused resignations among a panel of independent experts who said the therapy was ineffective.
U.S. FDA faces mounting criticism over Alzheimer's drug approval
The drug was authorized based on evidence that it can reduce brain plaques, a likely contributor to Alzheimer's, rather than proof that it slows progression of the disease.
Eisai sees potential of new Alzheimer's drug but costs remain concern
The approval by the U.S. Food and Drug Administration of the drug Aduhelm raised hopes, but patients can expect to be charged $56,000 a year.
Changing the game for Alzheimer's treatment, U.S. approves Eisai and Biogen's drug
The approval appears to signal a fundamental shift in the way the FDA thinks about Alzheimer's disease, which could have lasting ramifications for other drugs in the pipeline.
Eisai to start clinical trial of experimental drug for COVID-19
Japanese pharmaceutical firm Eisai Co. is set to start clinical trials in the United States of its experimental drug eritoran in the battle against coronavirus, with results potentially available by the year-end, the company said Wednesday. Eisai will test eritoran, initially developed to treat severe ...
Japanese firms take Brexit in stride but worry over British prospects for trade talks with EU
Japanese companies in Britain are taking the British exit from the European Union in stride, but some are wary that if Britain-EU trade talks falter, prospects for business in Europe will become uncertain. Many firms had already completed preparations for Britain's exit from the bloc, ...
Biogen builds case for its Alzheimer's drug, but skeptics say more data needed
Biogen Inc. laid out more data Thursday on its experimental Alzheimer's drug, raising no major safety alarms but also offering little compelling evidence that the drug, once declared a failure, actually works. Experts had been watching closely for any statistical abnormalities or excess safety issues ...
Japanese manufacturers are growing frustrated yet again over another delay in Britain's withdrawal from the European Union, as the prolonged confusion is raising concerns over disruptions to their businesses and supply chains. Britain is expected to postpone their withdrawal from the union, previously slated for ...