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Otsuka and Lundbeck Announce FDA Acceptance and Priority Review of sNDA for Brexpiprazole for the Treatment of Agitation Associated With Alzheimer’s Dementia
1/7/2023
Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S announce the U.S. Food and Drug Administration has determined that the supplementary New Drug Application for brexpiprazole for the use in the treatment of agitation associated with Alzheimer’s dementia is sufficiently complete to permit a substantive review.
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Eisai Submits Supplemental Biologics License Application to FDA for Traditional Approval of LEQEMBI™ (lecanemab-irmb) for the Treatment of Alzheimer's Disease
1/7/2023
Eisai Co., Ltd. and Biogen Inc. announced Eisai has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration supporting the conversion of the Accelerated Approval of LEQEMBI™ 100 mg/mL injection for intravenous use to a traditional approval.
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Eisai's Commitment to Scientific Evidence and Patient Safety
1/6/2023
LEQEMBI™ has the potential to make a difference for people living with early Alzheimer's disease, their loved ones and healthcare professionals, and was recently approved by the U.S. Food and Drug Administration for the treatment of AD.
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Eisai's Approach to U.S. Pricing for Leqembi™ (Lecanemab), a Treatment for Early Alzheimer's Disease, Sets Forth Our Concept of "Societal Value of Medicine" in Relation to "Price of Medicine"
1/6/2023
Based on hhc concept, our corporate philosophy, Eisai is committed to improve patients health outcomes and quality of life, simplify care delivery, increase health system efficiency and spur future investments in Alzheimer's disease.
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Third Patient Death Potentially Linked to Lecanemab Days Before Expected FDA Decision (Updated)
1/5/2023
A letter published Wednesday in the NEJM links a stroke patient's death to lecanemab. Eisai investigators respond. -
First Participants Enrolled in the AriBio USA Phase 3 Registration Trial to Evaluate AR1001 in Early Alzheimer’s Disease
1/5/2023
AriBio USA, a clinical-stage biopharmaceutical company, announced the enrollment of their first participants in their Phase 3 trial to evaluate the efficacy of AR1001 in participants with early Alzheimer’s Disease (AD).
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Sionna Therapeutics Announces Advancement of Cystic Fibrosis Pipeline Programs and Presentation at J.P. Morgan 41st Annual Healthcare Conference
1/5/2023
Sionna Therapeutics announced advancement of the company's preclinical and clinical development programs for novel small molecules designed to target the first nucleotide-binding domain of the cystic fibrosis transmembrane conductance regulator protein and complementary mechanisms.
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Alzamend Neuro Partners With Biorasi to Conduct a First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase I/IIA Clinical Trial
1/4/2023
Study to Assess the Safety, Tolerability, and Efficacy of Autologous Amyloid Beta Mutant Peptide-Pulsed Dendritic Cells (ALZN002) in Subjects With Mild-to-Moderate Dementia of the Alzheimer's Type.
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Two documents recently came to light: first, the results of a congressional investigation into the approval of Aduhelm; second, a revised clinical trial consent form for lecanemab.
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2022's Top Clinical Advancements: See Pivotal Data in NASH, Alzheimer’s, Sickle Cell Disease
12/23/2022
2022 featured pivotal data that could change the landscape in non-alcoholic steatohepatitis, Alzheimer’s disease, sickle cell disease and many more indications. -
INmune Bio, Inc., Virginia Commonwealth University, and Barrow Neurological Institute Receive Department of Defense Funding to Study the Role of Traumatic Brain Injury in the Development of Alzheimer’s Disease
12/22/2022
INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease in concert with Virgina Commonwealth University (VCU) and Barrow Neurological Institute have received a grant from the Department of Defense.
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Cognition Therapeutics Announces New “Conversations” Podcast Episode on Key Insights from Recent Clinical Trials in Alzheimer’s Disease
12/22/2022
Cognition Therapeutics, Inc. , (Nasdaq: CGTX), (the “Company” or “Cognition”) has released the second “Conversations” video podcast, featuring a virtual fireside discussion with neuroscience experts who share their perspective on clinical data recently presented at the 2022 CTAD conference in San Francisco, and implications for future Alzheimer’s disease,
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FDA agrees to Actinogen six-month Phase 2b Alzheimer's Disease trial
12/22/2022
Actinogen Medical Limited (ASX: ACW) is pleased to announce receipt today of agreement from the US Food and Drug Administration (FDA) to proceed with its six-month, Phase 2b, placebo-controlled clinical trial of Xanamem in patients with early stages of Alzheimer's Disease (AD).
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AlzeCure gets Abstract Accepted on New Potential Disease-Modifying Effects of ACD856 Against Alzheimer's
12/20/2022
AlzeCure Pharma announced that an abstract with new preclinical data supporting a disease-modifying effect of ACD856 has been accepted for presentation at the Alzheimer's Conference AD/PD 2023, to be held in Gothenburg, Sweden, March 28 - April 1.
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AlzeCure Gets Late-Breaking Abstract on New Data with Its Alzheimer Project Alzstatin Accepted At AD/PD 2023
12/15/2022
AlzeCure Pharma AB announced that an abstract with new preclinical Alzstatin data has been accepted for presentation at the Alzheimer conference AD/PD 2023, which will be held in Gothenburg, Sweden, on March 28 - April 1.
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Vertex is kicking off a Phase I trial assessing VX-522, an mRNA therapy designed to treat the underlying cause of cystic fibrosis lung disease, while SpliSense is targeting a specific mutation.
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SYNAPS Dx Releases Positive Budget Impact Results for DISCERNTM at International Conference on Aging Diseases and Elderly Care: Alzheimer’s Disease Diagnostic Projected to Save $4+ Million in Three Years
12/13/2022
SYNAPS Dx has released data from its study, “The Budget Impact of the DISCERN™ Diagnostic Test for Alzheimer’s Disease in the United States” presented at the International Conference on Aging Diseases and Elderly Care, December 9 – 10, 2022.
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Alzheimer’s Therapeutics market is projected to grow at a CAGR of 9.17% by 2032: Visiongain Reports Ltd
12/13/2022
Visiongain has published a new report entitled Alzheimer’s Therapeutics 2022-2032.
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(Updated) Aridis Pharmaceuticals Receives Equity Investment from the Cystic Fibrosis Foundation
12/12/2022
Aridis Pharmaceuticals, Inc., a biopharmaceutical company announced the Cystic Fibrosis Foundation invested $4.85 million in Aridis common stock on market terms under NASDAQ rules to support the ongoing development of AR-501, an inhalable broad-spectrum anti-infective currently under development for controlling debilitating chronic lung infections in cystic fibrosis patients.
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$11M NIH Grant Will Support Evaluation of Alzheimer's Screening Tool in Primary Care Settings
12/8/2022
Investigators at Albert Einstein College of Medicine, Montefiore Health System, Regenstrief Institute, and Indiana University School of Medicine have received an $11 million grant from the National Institutes of Health to evaluate an Einstein-developed test for assessing cognitive impairment and dementia.