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Top 2023 Neurodegenerative Readouts
4/17/2023
Clinical results for experimental treatments in Alzheimer’s, ALS and more are expected over the coming months. BioSpace highlights a few of the more highly anticipated datasets. -
With data from the Phase III trial of donanemab expected in Q2, Eli Lilly presented the first clinical results from its next anti-amyloid antibody, remternetug, at AD/PD 2023.
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Prothena Presents New Preclinical Data Supporting Best-in-Class Profile of PRX012, a Next-Generation Anti-Amyloid Beta Antibody, at AD/PD 2023
3/31/2023
Prothena Corporation plc (NASDAQ:PRTA) today announced new preclinical data from its PRX012 program, a potential best-in-class anti-amyloid beta (Aβ) product candidate in development for the treatment of Alzheimer’s disease, at the 2023 International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders (AD/PD) in Gothenburg, Sweden.
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Lead Therapeutic Candidate, PMN310, Demonstrates Enhanced Selectivity for Toxic Oligomers Compared to Other Amyloid-Beta-Directed Antibodies in Poster Presentation at AD/PD 2023
3/29/2023
ProMIS Neurosciences Inc. presented new in vitro preclinical data supporting the differentiation of PMN310 from other amyloid-beta -directed antibodies at the International Conference on Alzheimer’s and Parkinson’s Disease and Related Neurological Disorders.
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Prothena to Highlight Next Generation Treatments for Alzheimer’s and Parkinson’s Disease at the AD/PD 2023 Meeting
3/14/2023
Prothena Corporation plc announced broad participation at the 2023 International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders being held March 28 – April 1, 2023 in Gothenburg, Sweden, highlighting Prothena's leadership in advancing next generation treatments for Alzheimer’s and Parkinson’s disease.
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Data released Wednesday from the Phase III A4 study showed solanezumab fell short of its primary endpoint, failing to slow cognitive decline in patients with preclinical Alzheimer’s disease.
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Lilly Provides Update on A4 Study of Solanezumab for Preclinical Alzheimer's Disease
3/8/2023
Eli Lilly and Company (NYSE:LLY) announced today that solanezumab did not slow the progression of cognitive decline due to Alzheimer's disease (AD) pathology when initiated in individuals with amyloid plaque but no clinical symptoms of the disease, known as the preclinical stage of AD1.
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Billy Dunn, director of the FDA's Office of Neuroscience, is stepping down from his post to “explore other opportunities,” according to an internal FDA e-mail.
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Phase I/II data showed AC Immune’s anti-amyloid-beta vaccine candidate could safely elicit an antibody response in patients with Alzheimer’s disease. Now, it will expand to Down Syndrome patients.
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The FDA's approval of Biogen and Eisai's Leqembi and subsequent decision not to approve Eli Lilly's donanemab have sparked debate anew about the anti-amyloid theory in Alzheimer's.
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Research hasn't shown that removing amyloid plaques alone improves function in Alzheimer's patients, said Sharon L. Rogers, CEO of AmyriAD.
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The FDA issued a complete response letter Thursday refusing accelerated approval for Eli Lilly’s Alzheimer’s disease candidate donanemab.
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ADDF STATEMENT ON FDA DECISION NOT TO GRANT ACCELERATED APPROVAL TO DONANEMAB FOR TREATMENT OF ALZHEIMER'S DISEASE
1/20/2023
Drugmaker Eli Lilly & Co announced today that the FDA has issued a complete response letter, meaning it has not granted accelerated approval for amyloid-clearing antibody donanemab.
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U.S. Food and Drug Administration Issues Complete Response Letter for Accelerated Approval of Donanemab
1/19/2023
Eli Lilly and Company (NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the accelerated approval submission of donanemab for the treatment of early symptomatic Alzheimer's disease due to the limited number of patients with at least 12 months of drug exposure data provided in the submission.
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Following a banner year marked by the approval and launch of its diabetes drug Mounjaro, Eli Lilly revealed at the 41st J.P. Morgan Healthcare Conference that it was preparing for another big year.
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Lilly Announces 2023 Financial Guidance, Plans to Launch up to Four New Medicines
12/13/2022
Lilly expects to deliver strong financial and operational performance in 2023, highlighted by volume-driven revenue growth; potential launches for donanemab, mirikizumab, lebrikizumab and pirtobrutinib; potential regulatory submissions for tirzepatide in obesity; and numerous other anticipated pipeline advancements.
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Quanterix’s Simoa® Technology Drives Advances in Alzheimer’s Disease Research Presented at 2022 Clinical Trials on Alzheimer’s Disease (CTAD) Conference
12/5/2022
Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery through ultrasensitive biomarker detection, today announced that its Simoa® technology has powered important advances in ongoing clinical trials for the treatment of Alzheimer’s disease (AD).
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Eli Lilly’s investigational antibody donanemab met all of its primary and secondary endpoints in the Phase III TRAILBLAZER-ALZ 4 study, the company announced Wednesday.
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ADDF Statement on Gantenerumab Data Presented at CTAD
12/1/2022
The phase 3 trial results for lecanemab and gantenerumab presented at the Clinical Trials on Alzheimer's Disease conference demonstrate why optimal treatment of Alzheimer's will require drugs that do more than clear amyloid plaques.
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Lilly Shares Positive Donanemab Data in First Active Comparator Study in Early Symptomatic Alzheimer's Disease
11/30/2022
Eli Lilly and Company (NYSE: LLY) has announced that donanemab met all primary and secondary endpoints for the 6-month primary outcome analysis in the Phase 3 TRAILBLAZER-ALZ 4 study, providing the first active comparator data on amyloid plaque clearance in patients with early symptomatic Alzheimer's disease treated with amyloid-targeting therapies.