Treatment of Alzheimer's disease

Biogen to Present Data from ADUHELM and Alzheimer’s Disease Portfolio at 2021 Alzheimer’s Association International Conference

Retrieved on: 
Friday, July 23, 2021
Branches of biology, Biology, Medicine, Monoclonal antibodies, Treatment of Alzheimer's disease, Alzheimer's disease, Cognitive disorders, Psychiatric diagnosis, Aducanumab, Biomarker, Disease

There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.

Key Points: 
  • There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.
  • The companys contributions to the congress include four presentations on ADUHELM data and a total of 11 abstracts.
  • The company will also lead a late-breaking presentation on the design of the real-world observational Phase 4 study in Alzheimers disease, a prospective registry of ADUHELM, called International Collaboration for Real-World Evidence in Alzheimers Disease (ICARE AD-US).
  • Poster presentation: Reduction in Biomarkers of Alzheimers Disease Pathophysiology Following Treatment with Aducanumab Were Associated with Slowing Clinical Decline virtual poster #57499.

An open letter to the Alzheimer’s disease community from our Head of Research and Development, Alfred Sandrock, M.D., Ph.D.

Retrieved on: 
Thursday, July 22, 2021
Life sciences, Biology, Branches of biology, Aducanumab, Alzheimer's disease, Treatment of Alzheimer's disease, Biogen, Food and Drug Administration

CAMBRIDGE, Mass., July 22, 2021 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) - On June 7, 2021, ADUHELM became the first approved treatment to address a defining pathology of Alzheimer’s disease: targeting the reduction of amyloid plaques in the brain. We believe patients, family members and physicians deserve the facts about the therapy and the process by which it was approved so they may make informed decisions.

Key Points: 
  • There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.
  • We are equally proud of the professionalism both our team and the FDA demonstrated during a thorough review process.
  • We welcome a formal review into the interactions between the FDA and Biogen on the path to the approval of aducanumab.
  • The FDAs decision to approve ADUHELM to treat patients with Alzheimers disease was based on thorough analysis of the data.

FDA grants accelerated approval for ADUHELM™ as the first and only Alzheimer’s disease treatment to address a defining pathology of the disease

Retrieved on: 
Monday, June 7, 2021
Monoclonal antibodies, Branches of biology, Life sciences, Drugs, Amyloidosis, Aducanumab, Treatment of Alzheimer's disease, Alzheimer's disease, Biogen, Amyloid beta, Accelerated approval, Donanemab

Continued approval for ADUHELMs indication as a treatment for Alzheimers disease may be contingent upon verification of clinical benefit in confirmatory trial(s).

Key Points: 
  • Continued approval for ADUHELMs indication as a treatment for Alzheimers disease may be contingent upon verification of clinical benefit in confirmatory trial(s).
  • We are very pleased to be able to open a new chapter in the history of Alzheimers disease treatment with the approval of ADUHELM.
  • As part of the accelerated approval, Biogen will conduct a controlled trial to verify the clinical benefit of ADUHELM in patients with Alzheimers disease.
  • ADUHELM (aducanumab-avwa), a human monoclonal antibody, is the first and only Alzheimers disease treatment to address a defining pathology of the disease by reducing amyloid beta plaques in the brain.

Pinteon Therapeutics Announces First Patient Dosed in Phase 1 Study of PNT001 in Patients with Acute Traumatic Brain Injury

Retrieved on: 
Tuesday, April 6, 2021
Biotechnology, Pharmaceutical, Health, Clinical trials, Treatment of Alzheimer's disease, Clinical trials, Monoclonal antibodies, Palifermin, Bapineuzumab

Based on preclinical and human data, as well as promising safety results from our study of PNT001 in healthy volunteers, we believe our investigational therapy has the potential to block the spread of neurotoxic tau observed in traumatic brain injury.

Key Points: 
  • Based on preclinical and human data, as well as promising safety results from our study of PNT001 in healthy volunteers, we believe our investigational therapy has the potential to block the spread of neurotoxic tau observed in traumatic brain injury.
  • The randomized, double-blind, placebo-controlled multiple ascending dose study will enroll 64 patients across two dose level cohorts that, based on the Phase 1 study in healthy volunteers, will provide potentially therapeutic cerebrospinal fluid concentrations of PNT001.
  • Patients will be randomized to receive three monthly intravenous doses of PNT001 or placebo, and will receive their first dose within 24 hours of documented traumatic brain injury.
  • Pinteon Therapeutics is advancing clinical studies of a novel antibody that aims to interrupt the spread of toxic tau and protect and preserve brain function in patients with neurodegenerative disease.

GemVax & KAEL reports further positive data from GV1001 Phase II Alzheimer's Disease trial

Retrieved on: 
Monday, November 23, 2020
Health sciences, Cognitive disorders, Learning disabilities, Psychiatric diagnosis, Health, Branches of biology, Treatment of Alzheimer's disease, Nootropics, Alzheimer's disease, Donepezil, Dementia, Alzheimer's Disease Cooperative Study

SEOUL, Nov. 23, 2020 /PRNewswire/ -- GemVax & KAEL Co., Ltd. a clinical stage company developing a novel peptide drug based on telomerase modification has released further positive data at the Korean Dementia Association's Fall Conference from a Phase II trial in Alzheimer's disease of lead candidate GV1001.

Key Points: 
  • SEOUL, Nov. 23, 2020 /PRNewswire/ -- GemVax & KAEL Co., Ltd. a clinical stage company developing a novel peptide drug based on telomerase modification has released further positive data at the Korean Dementia Association's Fall Conference from a Phase II trial in Alzheimer's disease of lead candidate GV1001.
  • The newly released data also shows a statistically significant improvement in theNeuropsychiatric Inventory (NPI) and an improvement trend in Alzheimer's Disease Cooperative Study-Activities of Daily living (ADCS-ADL).
  • GemVax's GV1001 Phase II clinical trial evaluated the safety and efficacy of subcutaneous injection of GV1001 0.56 mg or 1.12 mg for six months in patients with moderate-to-severe Alzheimer's disease already receiving donepezil for more than three months, at 12 medical institutions.
  • Professor Koh, agrees, "If efficacy and safety results of GV1001 in the phase III clinical trial are the same as or superior to the Phase II clinical trial, it will be able to establish itself as a game-changer in Alzheimer's disease treatment".

GemVax & KAEL reports further positive data from GV1001 Phase II Alzheimer's Disease trial

Retrieved on: 
Monday, November 23, 2020
Health sciences, Cognitive disorders, Learning disabilities, Psychiatric diagnosis, Health, Branches of biology, Treatment of Alzheimer's disease, Nootropics, Alzheimer's disease, Donepezil, Dementia, Alzheimer's Disease Cooperative Study

SEOUL, Nov. 23, 2020 /PRNewswire/ -- GemVax & KAEL Co., Ltd. a clinical stage company developing a novel peptide drug based on telomerase modification has released further positive data at the Korean Dementia Association's Fall Conference from a Phase II trial in Alzheimer's disease of lead candidate GV1001.

Key Points: 
  • SEOUL, Nov. 23, 2020 /PRNewswire/ -- GemVax & KAEL Co., Ltd. a clinical stage company developing a novel peptide drug based on telomerase modification has released further positive data at the Korean Dementia Association's Fall Conference from a Phase II trial in Alzheimer's disease of lead candidate GV1001.
  • The newly released data also shows a statistically significant improvement in theNeuropsychiatric Inventory (NPI) and an improvement trend in Alzheimer's Disease Cooperative Study-Activities of Daily living (ADCS-ADL).
  • GemVax's GV1001 Phase II clinical trial evaluated the safety and efficacy of subcutaneous injection of GV1001 0.56 mg or 1.12 mg for six months in patients with moderate-to-severe Alzheimer's disease already receiving donepezil for more than three months, at 12 medical institutions.
  • Professor Koh, agrees, "If efficacy and safety results of GV1001 in the phase III clinical trial are the same as or superior to the Phase II clinical trial, it will be able to establish itself as a game-changer in Alzheimer's disease treatment".

ANI Pharmaceuticals Announces FDA Approval of Memantine Hydrochloride Extended-Release Capsules

Retrieved on: 
Monday, March 2, 2020
RTT, NMDA receptor antagonists, Amines, Memantine, Treatment of Alzheimer's disease, Food and Drug Administration, Health, Chemistry

BAUDETTE, Minn., March 2, 2020 /PRNewswire/ --ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that it has received approval of the Company's abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) for Memantine Hydrochloride Extended-Release Capsules 7 mg, 14 mg, 21 mg and 28 mg.The current annual U.S. market for this product is approximately $127 million, according to IQVIA.

Key Points: 
  • BAUDETTE, Minn., March 2, 2020 /PRNewswire/ --ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that it has received approval of the Company's abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) for Memantine Hydrochloride Extended-Release Capsules 7 mg, 14 mg, 21 mg and 28 mg.The current annual U.S. market for this product is approximately $127 million, according to IQVIA.
  • Memantine Hydrochloride Extended-Release Capsules are indicated for the treatment of moderate and severe dementia of the Alzheimer's type.
  • For more information, including the complete list of indications and usages, please see the Full Prescribing Information.
  • ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals.

BioArctic and Eisai Present New Data Regarding BAN2401 at the Alzheimer's Association International Conference 2019

Retrieved on: 
Thursday, July 18, 2019
Life sciences, Articles, Biogen, Spinal muscular atrophy, Biotechnology, Eisai, Monoclonal antibodies, Treatment of Alzheimer's disease

BAN2401 is a humanized monoclonal antibody that is the result of a strategic research alliance between BioArctic and Eisai.

Key Points: 
  • BAN2401 is a humanized monoclonal antibody that is the result of a strategic research alliance between BioArctic and Eisai.
  • Eisai obtained the global rights to study, develop, manufacture and market BAN2401 for the treatment of Alzheimer's disease pursuant to an agreement concluded with BioArctic in December 2007.
  • In March 2014, Eisai and Biogen entered into a joint development and commercialization agreement for BAN2401.
  • Since 2005, BioArctic has long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer's disease.

BioArctic and Eisai Present New Data Regarding BAN2401 at the Alzheimer's Association International Conference 2019

Retrieved on: 
Thursday, July 18, 2019
Life sciences, Articles, Biogen, Spinal muscular atrophy, Biotechnology, Eisai, Monoclonal antibodies, Treatment of Alzheimer's disease

BAN2401 is a humanized monoclonal antibody that is the result of a strategic research alliance between BioArctic and Eisai.

Key Points: 
  • BAN2401 is a humanized monoclonal antibody that is the result of a strategic research alliance between BioArctic and Eisai.
  • Eisai obtained the global rights to study, develop, manufacture and market BAN2401 for the treatment of Alzheimer's disease pursuant to an agreement concluded with BioArctic in December 2007.
  • In March 2014, Eisai and Biogen entered into a joint development and commercialization agreement for BAN2401.
  • Since 2005, BioArctic has long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer's disease.

BioArctic and Eisai to Present BAN2401 at the Alzheimer's Association International Conference 2019

Retrieved on: 
Thursday, July 11, 2019
Life sciences, Articles, Biogen, Spinal muscular atrophy, Biotechnology, Eisai, Monoclonal antibodies, Treatment of Alzheimer's disease

BAN2401 is a humanized monoclonal antibody that is the result of a strategic research alliance between BioArctic and Eisai.

Key Points: 
  • BAN2401 is a humanized monoclonal antibody that is the result of a strategic research alliance between BioArctic and Eisai.
  • Eisai obtained the global rights to study, develop, manufacture and market BAN2401 for the treatment of Alzheimer's disease pursuant to an agreement concluded with BioArctic in December 2007.
  • In March 2014, Eisai and Biogen entered into a joint development and commercialization agreement for BAN2401.
  • Since 2005, BioArctic has long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer's disease.