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While disease-modifying therapies largely steal the spotlight in Alzheimer’s drug development, several companies are working to solve this less-discussed but disruptive facet of the illness.
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Heather, Greg and Tyler discuss a busy news week including Wegovy's label expansion, biosimilars, surprise donanemab delays for Eli Lilly and speculate on election impact.
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The FDA plans to convene an advisory committee meeting to discuss the safety profile and efficacy of Eli Lilly’s Alzheimer’s candidate, the company announced Friday.
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The regulator’s new draft guidance, released on Monday, provides additional details regarding the use of surrogate and biomarker endpoints to support accelerated approvals.
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The FDA will convene its Peripheral and Central Nervous System Drugs Advisory Committee to discuss Eli Lilly’s application for its Alzheimer’s disease antibody donanemab, the company announced Friday.
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Alzheimer's Drug Discovery Foundation (ADDF) Statement on FDA Decision to Convene Advisory Committee for Donanemab
3/8/2024
Drugmaker Eli Lilly & Company today announced the FDA expects to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to further review and discuss donanemab's efficacy and safety profile before making its final decision on whether to grant the drug approval.
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U.S. Food and Drug Administration to Convene Advisory Committee Meeting to Discuss the TRAILBLAZER-ALZ 2 Study of Donanemab
3/8/2024
Eli Lilly and Company announced that the U.S. Food and Drug Administration expects to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to discuss the Phase 3 TRAILBLAZER-ALZ 2 trial, which evaluated the efficacy and safety of donanemab in early symptomatic Alzheimer's disease.
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FDA Delays Approval of Donanemab for the Treatment of Early-Stage Alzheimer’sAgency to convene an advisory committee to consider the drug
3/8/2024
The maker of donanemab, Eli Lilly, announced today that the Food and Drug Administration (FDA) will convene an advisory committee to consider the drug’s safety and efficacy, further delaying approval of the promising drug.
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Neurophet introduces AI-powered brain imaging analysis technology at AD/PD 2024
3/4/2024
Neurophet, an artificial intelligence (AI) solution company for brain disease, announced its participation in the international conference on Alzheimer's and Parkinson's diseases and related neurological disorders (AD/PD 2024).
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BioArctic: Latest data on lecanemab to be presented at the 2024 AD/PD™ congress
2/29/2024
BioArctic AB announced that the company and its partner Eisai will present new data on lecanemab at the 2024 International Conference on Alzheimer's and Parkinson's Diseases and related neurological disorders, to be held in Lisbon, Portugal and virtually, March 5-9.
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EISAI TO PRESENT DATA ON LECANEMAB and OTHER ALZHEIMER'S DISEASE RESEARCH AT THE AD/PD™ 2024 ANNUAL MEETING
2/28/2024
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today the company will present the latest findings on lecanemab (U.S. brand name: LEQEMBI®), Eisai's anti-amyloid beta (Aβ) protofibril* antibody for the treatment of Alzheimer's disease (AD), at the 2024 International Conference on Alzheimer's and Parkinson's Diseases and related neurological disorders (AD/PD™) from March 5-9 in Lisbon, Portugal, and virtually.
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In this deep dive, BioSpace examines what’s next for Leqembi, the true cost of anti-amyloid antibodies, and what other Alzheimer’s treatments are coming down the pipeline.
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With one disease-modifying therapy already reaching patients and another expected to soon, several biopharma companies anticipate key data for novel assets in the coming 12 months.
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Biotech companies are exploring multiple targets in the fight against neuroinflammation. Experts say these projects could yield the next breakthrough in treating Alzheimer’s disease.
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Breakthrough in Treating Alzheimer's Using Targeted Drug Delivery Reported in New England Journal of Medicine
1/3/2024
A potential advancement in the treatment of Alzheimer’s disease was announced today by researchers at the West Virginia University Rockefeller Neuroscience Institute (RNI).
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WRQ Sciences and Superfluid Dx., Inc. Announce Completion of Oversubscribed Series A Financing in Breakthrough Alzheimer's Disease Diagnostic Company Superfluid Dx
12/20/2023
WRQ Sciences and Superfluid Dx, Inc., announced the completion of an oversubscribed Series A financing led by WRQ Sciences.
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To protect the central nervous system, the blood-brain barrier bars entry to around 98% of molecules—but approaches like Roche’s trontinemab could spell new hope in Alzheimer’s and beyond.
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Lilly Reports Third-Quarter 2023 Financial Results, Highlights Strong Sales Growth and Business Development Activity
11/2/2023
Lilly defines New Products as select products launched since 2022, which currently consist of Jaypirca, Mounjaro and Omvoh.
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Life Molecular Imaging and Sinotau Pharmaceutical Group Announce the Regulatory Approval of their Amyloid PET Imaging Radiopharmaceutical Neuraceq® in China
10/24/2023
Life Molecular Imaging and Sinotau Pharmaceutical Group are pleased to announce Neuraceq® has received regulatory approval from National Medical Products Administration in China.
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New data from LEQEMBI® (lecanemab-irmb) phase 3 Clarity AD study and subcutaneous formulation to be presented at CTAD
10/16/2023
BioArctic AB's partner Eisai will present new data from the phase 3 Clarity AD study for its Alzheimer's disease treatment LEQEMBI® 100 mg/mL injection for intravenous use, as well as new data on the subcutaneous formulation in development at the 16th annual Clinical Trials on Alzheimer's Disease conference.