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2023-05-21 12:00:17 ET Developers have increasingly relied on an FDA shortcut to win accelerated drug approvals while their confirmatory trials got delayed at the expense of billions to the government-backed healthcare system, a recent analysis from Bloomberg News indicates. The...
2023-05-18 11:30:11 ET Cognition Therapeutics ( NASDAQ: CGTX ) stock rose ~9% on Thursday after the company said data for CT1812 was published in the journal Translational Neurodegeneration . The manuscript is titled, 'A Phase 1b Randomized Clinical Trial of CT1812 ...
2023-05-17 12:13:55 ET Alzheimer's drug developer Prothena Corporation ( NASDAQ: PRTA ) announced Tuesday that Billy Dunn, who previously led the FDA's Office of Neuroscience, is joining the company's board of directors. The appointment comes less than three months after the FDA...
2023-05-15 12:35:17 ET Eisai press release ( OTCPK:ESALF ): FY GAAP EPS of ¥193.31. Revenue of ¥744.4B (-1.6% Y/Y). For further details see: Eisai GAAP EPS of ¥193.31, revenue of ¥744.4B
2023-05-14 14:20:00 ET Summary Bliss Biopharma (Hangzhou) announced it may out-license global rights (ex-China) for its HER2 ADC to Japan’s Eisai Pharma in a deal with a potential value of $2 billion. Shanghai Junshi Bio out-licensed regional rights for its anti-PD-1 mAb to...
2023-05-11 05:56:21 ET The U.S. Food and Drug Administration (FDA) approved the expanded use of H. Lundbeck ( OTCPK:HLBBF ) ( OTCPK:HLUBF ) and Otsuka's ( OTCPK:OTSKY ) ( OTCPK:OTSKF ) medicine Rexulti (brexpiprazole) to treat agitation associated with dementia due to Alzh...
2023-05-06 01:58:52 ET Summary Like other anti-amyloid drugs, Eli Lilly's donanemab does not help APOE4 non-carriers. Donanemab does modestly slow down the progression of Alzheimer's disease during its early stages in APOE4 carriers but can cause brain bleeds and brain swelling, w...
2023-05-03 22:35:00 ET Summary Eli Lilly made headlines this morning with an announcement that their anti-amyloid antibody donanemab hit its endpoints in a Phase III clinical trial. The natural comparison is with lecanemab (Leqembi), the recently approved antibody from Eisai and B...
2023-05-03 15:37:28 ET Eli Lilly ( NYSE: LLY ) added ~7% to reach a new 52-week high Wednesday after the company reported early Phase 3 data for its anti-amyloid agent donanemab in Alzheimer's disease, sparking sharp gains among rival drug developers. Notable gainers include...
2023-05-01 08:47:05 ET After three straight sessions of gains, Biogen ( NASDAQ: BIIB ) shares continued to rise in the pre-market Monday as Guggenheim upgraded the biotech citing full FDA approval for its Alzheimer's therapy Leqembi developed with Eisai ( OTCPK:ESALF )( OTCPK:...
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"LEQEMBI" Lecanemab) Approved for the Treatment of Alzheimer's Disease in Israel TOKYO and CAMBRIDGE, Mass., July 12, 2024 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced today that humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody "LEQEMB...
"LEQEMBI" (Lecanemab) Approved for the Treatment of Alzheimer's Disease in Hong Kong TOKYO and CAMBRIDGE, Mass., July 11, 2024 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced today that the Department of Health in HongKong has approved humanized anti-soluble aggregated ...
Eisai Announces Move to Solo Development and Commercialization of Farletuzumab Ecteribulin (FZEC) Antibody Drug Conjugate (ADC) TOKYO, July 2, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has agreed to end its global strategic collaboration with Bristol Myers Squi...