Hints and tips:
...Concerns over an additional FDA review of donanemab could give Eisai a chance to win greater market share....
...In the UK, Eisai submitted the drug for approval in May....
...Eisai said it was encouraged by “ongoing productive discussions” with CMS about lifting the restrictions....
...Eisai said it could not comment on individual cases because of patient privacy....
...“Eisai believes these findings will create new horizons in the diagnosis and treatment of Alzheimer’s disease as well as further activate innovation for new treatment options,” said Haruo Naito, Eisai’s...
...The US biotech has been developing the treatment with Eisai of Japan....
...Lecanemab originated with BioArctic, a small Swedish company that collaborated with Eisai and then Biogen to take it through clinical trials....
...Scientists also applauded Japanese drugmaker Eisai three weeks ago after data showed its new Alzheimer’s drug slowed cognitive decline. There are questions over safety....
...That is why the design of the trial . . . is so important,” Ivan Cheung, US chief executive of Eisai, said in an interview....
...quickly . . . our assumption is nothing until year end,” said Yee, who added this could potentially change if clinical trials of a separate Alzheimer’s drug being developed by Biogen and Japanese group Eisai...
...“If you look at us from any angle, we’re all about dementia,” Naito, the 73-year-old grandson of Eisai’s founder, said....
...On Wednesday, Biogen said Aduhelm, the drug it has developed with Japan’s Eisai, received a “negative trend vote” from the Committee for Medicinal Products for Human Use panel on its application for marketing...
...“We have always believed that the amyloid pathway is a defining, underlying pathology for Alzheimer’s disease,” Ivan Cheung, chair of Eisai, told the Financial Times....
...The treatment, developed by Biogen and Japanese drugmaker Eisai, is the first to be approved that purports to slow progression of the disease....
...The stock price of Japanese drugmaker Eisai, Biogen’s development partner on aducanumab, surged 56 per cent....
...But the drug, which Biogen made alongside Japanese company Eisai, has been mired in controversy, with many arguing that the treatment simply does not work....
...Japan’s Eisai in February pulled its weight management Belviq drug from American shelves after the Food and Drug Administration flagged health risks....
...The company’s stock had dropped in March when it and its Japanese partner Eisai said they would halt trials after a futility analysis by an independent monitoring committee indicated the drug was not going...
...Biogen’s stock plummeted earlier this year after it shut down a trial for a treatment for Alzheimers, along with its partner Japanese pharmaceutical company Eisai....
...The decision comes after Biogen, a neuroscience-focused biotech company, closed down its Alzheimer’s drug trial with Japanese company Eisai in April, after they found the drug was not going to be effective...
...Biogen and Eisai have not yet released the full results of their trail but experts believe the drug may have been working on the wrong target....
...The Biogen-Eisai statement said the recommendation to stop the studies was not based on safety concerns....
...The stock fell 30 per cent in one day after the failure of a trial of an experimental drug for Alzheimer’s developed by Biogen with its Japanese partner Eisai....
...Eisai and Biogen released hotly anticipated results from a trial of their Alzheimer’s drug, which appeared to show the medicine can arrest the rate at which patients lose their brainpower....
...Biogen and Eisai have notched a rare success in the notoriously difficult field of Alzheimer’s research, announcing that one of their experimental drugs had succeeded in a mid-stage clinical trial....
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