Biogen

Global Asset Purchase Partnering Terms and Agreements in Pharma, Biotech and Diagnostics 2016 to 2023 - ResearchAndMarkets.com

Retrieved on: 
Friday, April 7, 2023
Professional Services, Business, Chapter Four, GSK, Amgen, Actavis, Intellectual property, Baxter, Mecum Dealmakers, Roche, A-Z, Record, Orientation, Confidentiality, AstraZeneca, Chapter Three, Sale, Eli Lilly, J&J, Chapter One, Chapter, Kyowa Kirin, Bausch Health, Acquisition, Novartis, Chapter Five, Chapter Six, Appendix, Merck, Biogen, BMS, Insight, Hyperlink, Common, Fine chemical, Airline, Security (finance), Cryptocurrency, Bookkeeping, Commercial property, Risk management, Property management, Lease, Pharma, Teva, Astellas Pharma, Takeda, Bayer, Pfizer

The "Global Asset Purchase Partnering Terms and Agreements in Pharma, Biotech and Diagnostics 2016 to 2023" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Asset Purchase Partnering Terms and Agreements in Pharma, Biotech and Diagnostics 2016 to 2023" report has been added to ResearchAndMarkets.com's offering.
  • The Global Asset Purchase Deals in Pharma, Biotech and Diagnostics 2016-2023 report provides a detailed understanding and analysis of how and why companies enter business, product, technology and royalty assets.
  • The chapter includes numerous case studies to enable understanding of both pure asset purchase deals and multicomponent deals where asset purchase forms a part.
  • The Global Asset Purchase Deals in Pharma, Biotech and Diagnostics 2016-2020 report provides comprehensive access to available records for over 950 asset purchase deals, including contract documents where available.

Legend Biotech Establishes Strategic Advisory Board

Retrieved on: 
Monday, April 3, 2023
Biotechnology, Pharmaceutical, Health, Alnylam Pharmaceuticals, Doctor of Philosophy, Biogen, Pharmaceutical industry, Management

Legend Biotech Corporation (“Legend Biotech” or the “Company”) (NASDAQ: LEGN), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today announced the formation of a strategic advisory board and the appointments of Michel Vounatsos, former CEO of Biogen Inc., and John Maraganore, PhD, former CEO of Alnylam Pharmaceuticals, as advisors.

Key Points: 
  • Legend Biotech Corporation (“Legend Biotech” or the “Company”) (NASDAQ: LEGN), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today announced the formation of a strategic advisory board and the appointments of Michel Vounatsos, former CEO of Biogen Inc., and John Maraganore, PhD, former CEO of Alnylam Pharmaceuticals, as advisors.
  • Mr. Vounatsos and Dr. Maraganore will work closely with Legend Biotech’s leadership team and Board of Directors to advise on strategic initiatives to advance the Company’s cell therapy platforms.
  • “We are honored to be joined by such accomplished industry executives, and we welcome Mr. Vounatsos and Dr. Maraganore to our advisory board.
  • We look forward to drawing upon their unique global perspectives and combined experience to help drive the company’s long-term growth objectives,” said Ying Huang, Legend Biotech’s CEO.

Global Royalty Rate Trends in Pharma and Biotech Dealmaking 2010-2023: One-Stop Source for Providing Real-Deal Information on Hundreds of Transactions

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Friday, April 7, 2023
Chapter Four, GSK, Amgen, Actavis, Intellectual property, Biotechnology, Baxter, Roche, Orientation, Confidentiality, AstraZeneca, Chapter Three, Eli Lilly, J&J, Chapter, Chapter One, Literature, Kyowa Kirin, Bausch Health, Novartis, Chapter Five, Appendix, Merck, Biogen, BMS, Insight, Hyperlink, Music, Pharmaceutical industry, Commercial property, Fine chemical, Real estate, Lease, Risk management, Property management, Pharma, Teva, Astellas Pharma, Takeda, Bayer, Pfizer

DUBLIN , April 7, 2023 /PRNewswire/ -- The "Global Royalty Rate Trends in Pharma and Biotech Dealmaking 2010-2023" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN , April 7, 2023 /PRNewswire/ -- The "Global Royalty Rate Trends in Pharma and Biotech Dealmaking 2010-2023" report has been added to ResearchAndMarkets.com's offering.
  • The Global Royalty Rate Trends in Pharma and Biotech Dealmaking 2010 - 2023 report is your one-stop source for providing real-deal information on hundreds of transactions, including the technology licensed, royalty rates, license fees, upfront and milestone payments.
  • The initial chapters of this report provide an orientation of royalty rate trends in pharma and biotech since 2010.
  • The Global Royalty Rate Trends in Pharma and Biotech Dealmaking 2010-2023 report provides comprehensive access to available contract documents for licensing deals.

Lauder Family Donates $200 Million to Alzheimer's Drug Discovery Foundation for Development of Novel Methods to Prevent, Diagnose, Treat, and Cure Alzheimer's Disease

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Tuesday, April 4, 2023
Fillit, Vacuum, Florbetapir (18F), Biogen, Alzheimer's Drug Discovery Foundation, Lauder, Ageing, Cancer, MacKenzie Scott, Research, Brain, Attention, Biomarker, Leonard Lauder, Government, Science, Amyloid, Patient, Aerin Lauder, Drug combination, Medicine, Biology, Entrepreneurship, Eli Lilly and Company, Family, Disease, Pharmaceutical industry, Medical imaging, Alzheimer's disease

NEW YORK, April 4, 2023 /PRNewswire/ -- The Alzheimer's Drug Discovery Foundation (ADDF) today announced that Leonard A. Lauder and Ronald S. Lauder, along with the entire third generation of their family, William Lauder, Gary Lauder, Aerin Lauder Zinterhofer, and Jane Lauder, have committed $200 million to accelerate the discovery and development of drugs to prevent and treat Alzheimer's disease. This is the largest gift ever given to the ADDF – underscoring the Lauder family's dedication to curing Alzheimer's.

Key Points: 
  • "Alzheimer's disease doesn't affect just one person, it impacts entire families," said Leonard A. Lauder, Co-Chairman and Co-Founder of the ADDF.
  • "That is why this family gift sets the stage for the next generation to tackle and ultimately end this devastating disease.
  • We are seeing important progress, and we feel confident that this gift will build on the current momentum to cure Alzheimer's disease."
  • "This disease cannot be solved in a vacuum, and the Lauder family understands no one goes through Alzheimer's alone.

NDA Partners Appoints Senior Global Regulatory Affairs Executive, Dr. Daniela Drago as Partner in the Firm

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Tuesday, April 4, 2023
CSL Vifor, RAPS, Medical school, Swiss Federal Institute of Technology, Swiss, Biozentrum University of Basel, University, Gene, Swiss Federal Institute of Aquatic Science and Technology, ETH, Biogen, CMC, Roche, George Washington University Hospital, Bausch, Regulatory science, History, Doctor of Philosophy, Associate, Bausch & Lomb, ECPM, MS, FRAPS, Partner, UCSF, Ophthalmology, School, Cell, Executive Committee, Drug development, American Society of Gene and Cell Therapy, University of Messina, Regulatory affairs, George Washington University, Neurology, Pharmaceutical medicine, Society, Pharmaceutical industry, Medicine, Chemistry

WASHINGTON, April 4, 2023 /PRNewswire-PRWeb/ -- NDA Partners' Vice President and General Manager, Eric Fish, announced today that Dr. Daniela Drago, a senior global regulatory affairs executive, has been appointed as Partner in the firm. Dr. Drago first worked as an Expert Consultant with NDA Partners in 2014 and formerly held senior global regulatory and medical affairs positions at Biogen, Roche, Vifor Pharma, Reckitt Benckiser, Aurion Biotech, and Bausch & Lomb.

Key Points: 
  • NDA Partners' Vice President and General Manager, Eric Fish, announced today that Dr. Daniela Drago, a senior global regulatory affairs executive, has been appointed as Partner in the firm.
  • Dr. Drago first worked as an Expert Consultant with NDA Partners in 2014 and formerly held senior global regulatory and medical affairs positions at Biogen, Roche, Vifor Pharma, Reckitt Benckiser, Aurion Biotech, and Bausch & Lomb.
  • WASHINGTON, April 4, 2023 /PRNewswire-PRWeb/ -- NDA Partners' Vice President and General Manager, Eric Fish, announced today that Dr. Daniela Drago , a senior global regulatory affairs executive, has been appointed as Partner in the firm.
  • Dr. Drago is a CMC and global regulatory affairs executive with a history of accomplishments spanning pharmaceutical, biotech, and academic roles.

Long-term health outcomes for lecanemab using simulation model and Phase 3 Clarity AD data published

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Tuesday, April 4, 2023
Priority review, Plaque, CET, MHLW, Marketing, Advisory Committee, Memantine, Food, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, Lecanemab, Clinical trial, Quality of life, Ministry of Health, Labour and Welfare, Brain, Alzheimer's disease, SOC, MCI, Medication, Pharmaceuticals and Medical Devices Agency, Advisory Committee on Immunization Practices, EMA, Clarity, Ministry, Eisai, Prescription Drug User Fee Act, HIV disease progression rates, Patient, Standard of care, PMDA, National Medical Products Administration, Co-promotion, PDUFA, Ministry of Health (Kuwait), Neurology, MAA, AD, FDA, BLA, NMPA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Disease, Caregiver, Safety, Pharmaceutical industry, Biogen, Health

A subgroup analysis suggested that earlier initiation of treatment with lecanemab may have a greater impact on disease progression.

Key Points: 
  • A subgroup analysis suggested that earlier initiation of treatment with lecanemab may have a greater impact on disease progression.
  • This paper has been revised to incorporate data from the Phase 3 Clarity AD clinical trial, replacing the previous simulation of long-term health outcomes which relied on results from the Phase 2b clinical trial, published in April 2022.
  • The analysis is based on a disease simulation model (AD ACE model[3]) that used data from the Phase 3 Clarity AD clinical trial, which evaluated the efficacy and safety of lecanemab, and published literature to simulate the natural progression of AD.
  • The U.S. Food and Drug Administration (FDA) determined that the results of Clarity AD can serve as the confirmatory study to verify the clinical benefit of lecanemab.

Long-term health outcomes for lecanemab using simulation model and Phase 3 Clarity AD data published

Retrieved on: 
Tuesday, April 4, 2023
Priority review, Plaque, CET, MHLW, Marketing, Advisory Committee, Memantine, Food, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, Lecanemab, Clinical trial, Quality of life, Ministry of Health, Labour and Welfare, Brain, Alzheimer's disease, SOC, MCI, Medication, Pharmaceuticals and Medical Devices Agency, Advisory Committee on Immunization Practices, EMA, Clarity, Ministry, Eisai, Prescription Drug User Fee Act, HIV disease progression rates, Patient, Standard of care, PMDA, National Medical Products Administration, Co-promotion, PDUFA, Ministry of Health (Kuwait), Neurology, MAA, AD, FDA, BLA, NMPA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Disease, Caregiver, Safety, Pharmaceutical industry, Biogen, Health

A subgroup analysis suggested that earlier initiation of treatment with lecanemab may have a greater impact on disease progression.

Key Points: 
  • A subgroup analysis suggested that earlier initiation of treatment with lecanemab may have a greater impact on disease progression.
  • This paper has been revised to incorporate data from the Phase 3 Clarity AD clinical trial, replacing the previous simulation of long-term health outcomes which relied on results from the Phase 2b clinical trial, published in April 2022.
  • The analysis is based on a disease simulation model (AD ACE model[3]) that used data from the Phase 3 Clarity AD clinical trial, which evaluated the efficacy and safety of lecanemab, and published literature to simulate the natural progression of AD.
  • The U.S. Food and Drug Administration (FDA) determined that the results of Clarity AD can serve as the confirmatory study to verify the clinical benefit of lecanemab.

BioArctic: New lecanemab-data presented at the AD/PD™ 2023 conference

Retrieved on: 
Monday, April 3, 2023
Amyloid-related imaging abnormalities, Anticoagulant, Apolipoprotein E, Genotype, Intracerebral hemorrhage, CET, Clinical trial, The New England Journal of Medicine, Edema, DSM-IV codes, Horseshoe kidney, Siderosis, Quality, Science, Clarity, Eisai, Aria, Incidence, ARIA, Dementia, QOL, International Conference on Population and Development, Lecanemab, HIV disease progression rates, Patient, Randomness, Quality of life (healthcare), Quality of life, Co-promotion, 2023 International Conference on Climate Resilient Pakistan, Conference, Pharmaceutical industry, Alzheimer's disease, Biogen

Lecanemab met the primary endpoint and all key secondary endpoints with highly statistically significant results.

Key Points: 
  • Lecanemab met the primary endpoint and all key secondary endpoints with highly statistically significant results.
  • In November 2022, results of the Clarity AD study were presented at the Clinical Trials on Alzheimer's Disease (CTAD) conference and simultaneously published in the peer-reviewed medical journal, The New England Journal of Medicine .
  • His presentation concluded that lecanemab has a unique binding profile, with strong selectivity for protofibrils over monomers and fibrils of Aβ.
  • The information was released for public disclosure, through the agency of the contact person below, on April 3, 2023, at 08:00 a.m. CET.

BioArctic: New lecanemab-data presented at the AD/PD™ 2023 conference

Retrieved on: 
Monday, April 3, 2023
Amyloid-related imaging abnormalities, Anticoagulant, Apolipoprotein E, Genotype, Intracerebral hemorrhage, CET, Clinical trial, The New England Journal of Medicine, Edema, DSM-IV codes, Horseshoe kidney, Siderosis, Quality, Science, Clarity, Eisai, Aria, Incidence, ARIA, Dementia, QOL, International Conference on Population and Development, Lecanemab, HIV disease progression rates, Patient, Randomness, Quality of life (healthcare), Quality of life, Co-promotion, 2023 International Conference on Climate Resilient Pakistan, Conference, Pharmaceutical industry, Alzheimer's disease, Biogen

Lecanemab met the primary endpoint and all key secondary endpoints with highly statistically significant results.

Key Points: 
  • Lecanemab met the primary endpoint and all key secondary endpoints with highly statistically significant results.
  • In November 2022, results of the Clarity AD study were presented at the Clinical Trials on Alzheimer's Disease (CTAD) conference and simultaneously published in the peer-reviewed medical journal, The New England Journal of Medicine .
  • His presentation concluded that lecanemab has a unique binding profile, with strong selectivity for protofibrils over monomers and fibrils of Aβ.
  • The information was released for public disclosure, through the agency of the contact person below, on April 3, 2023, at 08:00 a.m. CET.

EISAI PRESENTED NEW ANALYSES OF ARIA AND QOL ON LECANEMAB IN CLARITY AD AT THE AD/PD™ 2023 ANNUAL MEETING

Retrieved on: 
Friday, March 31, 2023
Amyloid-related imaging abnormalities, Anticoagulant, Apolipoprotein E, Intracerebral hemorrhage, Disease, Alzheimer's disease, Clinical trial, The New England Journal of Medicine, Overalls, BIIB, Quality of life, Horseshoe kidney, Siderosis, Quality, ARIA-H, The Different Forms of Flowers on Plants of the Same Species, Incidence, QOL, Dementia, ARIA, International Conference on Population and Development, Patient, Headquarters, Randomness, Corporation, Quality of life (healthcare), Co-promotion, 2023 International Conference on Climate Resilient Pakistan, Caregiver burden, Conference, Pharmaceutical industry, Biogen, Lecanemab, Clarity, Eisai

Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early Alzheimer's disease (AD) (lecanemab group: 10 mg/kg bi-weekly IV treatment: 898, placebo group: 897).

Key Points: 
  • Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early Alzheimer's disease (AD) (lecanemab group: 10 mg/kg bi-weekly IV treatment: 898, placebo group: 897).
  • Lecanemab Phase 3 Clarity AD Trial: ARIA With the Use of Antiplatelets or Anticoagulants in Early Alzheimer's Disease
    In the Clarity AD study, ARIA rates were higher for patients receiving lecanemab compared to those on placebo.
  • In Clarity AD, the pattern of occurrence of isolated ARIA-H in lecanemab group was similar to that in placebo group.
  • The results of the Clarity AD Health-related QoL measures presented additional evidence for meaningful benefits of lecanemab treatment to patients and care partners.