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It was a busy week for clinical trial announcements. Here's a look.
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Latest Findings On Lecanemab - Clinical Efficacy, Aria Rates, Biomarkers Relationship To Clinical Outcomes And Dosing Regimens - Presented At AD/PD™ 2022 Annual Meeting
3/21/2022
Eisai Co., Ltd. and Biogen Inc. announced that the latest findings on lecanemab, an investigational anti-amyloid-beta protofibril antibody being developed for the treatment of early Alzheimer's disease, were presented at the Aβ Targeted Therapies in AD 2 Symposium at the 2022 International Conference on Alzheimer's and Parkinson's Diseases March 15-20 in Barcelona, Spain and virtually.
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Biogen reported new data from a long-term extension phase of the Phase III clinical studies of Aduhelm (aducanumab) for Alzheimer’s disease.
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Long-Term Phase 3 Data Show ADUHELM® Continues to Reduce Underlying Pathologies of Alzheimer’s Disease in Patients Treated for More Than Two Years
3/16/2022
Biogen announced new data showing that after nearly two and a half years of treatment (128 weeks) with ADUHELM.
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Biogen Announces Peer-Reviewed Publication of ADUHELM® Phase 3 EMERGE and ENGAGE Data in The Journal of Prevention of Alzheimer’s Disease
3/16/2022
Biogen Inc. (Nasdaq: BIIB) announced that The Journal of Prevention of Alzheimer’s Disease (JPAD) today published a peer-reviewed manuscript detailing data from the pivotal Phase 3 EMERGE and ENGAGE trials for ADUHELM® (aducanumab-avwa) 100 mg/mL injection for intravenous use in early Alzheimer’s disease.
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Tokyo-based Eisai Inc. and Biogen announced modifications to their existing collaboration on developing the drug Aduhelm (aducanumab).
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Biogen and Eisai amend collaboration agreements on Alzheimer’s disease treatments
3/14/2022
Biogen Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) announced today that the companies have amended their existing collaboration agreement on aducanumab, which is commercialized in the United States as ADUHELM® (aducanumab-avwa).
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Biogen to Present New Research at the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD 2022)
3/11/2022
Biogen Inc. announced the company will present new Alzheimer’s disease research, as well as data for ADUHELM® injection 100 mg/mL for intravenous use, at the upcoming International Conference on Alzheimer’s and Parkinson’s Diseases, taking place March 15-20 in Barcelona, Spain and virtually.
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Eisai To Present New Lecanemab Data Exploring Distinct Mechanism of Action and Clinical Outcomes, Disease State Symposium, and Other Pipeline Assets at the AD/PD™ 2022 Annual Meeting
3/10/2022
Eisai Co., Ltd. announced the company will present research from its robust Alzheimer's disease pipeline, including the latest findings on lecanemab, Eisai's investigational anti-amyloid beta protofibril antibody for the treatment of early AD, at the AD/PD™ 2022 International Conference on Alzheimer's and Parkinson's Diseases from March 15-20 in Barcelona, Spain and virtually.
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Alzheon to Present ALZ-801 (Valiltramiprosate) Phase 3 Program Update and Industry-Leading Disease Modifying Effects from Phase 2 Trial in Patients with Early Alzheimer’s Disease at AD/PD and NDDS Scientific Conferences
3/8/2022
Alzheon, Inc. announced that it will be presenting at the 16th International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders to be held on March 15-20, 2022, in Barcelona, Spain, and the 10th Annual Neurodegenerative Drug Development Summit to be held on March 28-30, 2022, in Boston, MA, USA.
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After months of speculation about looming layoffs, Biogen is handing out pink slips in order to save about $500 million.
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The FDA has not yet issued any hold orders to Cassava, but the company expects that its time is coming after rivals Denali and Cortexyme received theirs.
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AevisBio Publishes Data with NIH Demonstrating Novel Immunomodulatory Imide Drug Reduces Neuroinflammation and Prevents Cognitive Impairment in Alzheimer’s Disease Model
3/2/2022
AevisBio today announced publication of key research demonstrating 3,6’-dithiopomalidomide (3,6’-DP or AEV103) decreases neuroinflammation and mitigates cognitive decline in the presence of progressive amyloid-beta (Aβ).
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Halberd has demonstrated it can control each of the top 10 antigens associated with various neurodegenerative diseases, including Alzheimer’s, Parkinson’s, epilepsy, TBI and PTSD.
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It's not clear if the recent deaths reported in FAERS resulted from the patients taking Aduhelm. This article takes a deep dive into this controversy.
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CMS says it would only cover the cost of Biogen’s Aduhelm and any required scans “if they are enrolled in qualifying clinical trials.”
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CMS issued a draft decision for Biogen’s Alzheimer’s drug and said it would only cover the cost of Aduhelm and any required scans “if they are enrolled in qualifying clinical trials.”
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Alzheon Reports Industry-Leading Disease Modifying Effects from Phase 2 Biomarker Trial of Oral Tablet ALZ-801 (Valiltramiprosate) in Patients with Early Alzheimer’s Disease
2/8/2022
Alzheon, Inc. reported a clinically relevant and statistically significant plasma biomarker reduction and memory improvement in Alzheimer’s patients following 6 months of treatment with oral tablet ALZ-801 in its Phase 2 biomarker trial.
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This particular renewal panel discussion took an unexpected turn, focusing on Biogen’s controversial drug.
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The company indicated that its timeline for an accelerated approval request for its own Alzheimer’s drug, donanemab, was no longer on schedule for the first quarter after the CMS draft guidance.