NDS

Health Canada Accepts Valneva’s Chikungunya Vaccine License Application for Review

Retrieved on: 
火曜日, 8月 29, 2023
Epidemic, Priority review, NDS, Biologics license application, Pan American Health Organization, Saint-Herblain, Priority, Marketing, Coalition, European Medicines Agency, Valneva SE, CEPI, PAHO, Coalition for Epidemic Preparedness Innovations, Licensure, Chikungunya, Person, Trial of the century, Fast track (FDA), EMA, Euronext Paris, VLA, MD, Instituto Butantan, Ageing, FDA, Health Canada, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Food, Pharmaceutical industry, Vaccine, Lancet

Based on Health Canada’s performance standard to process an NDS application, the Company believes the regulatory review could be completed by mid-2024.

Key Points: 
  • Based on Health Canada’s performance standard to process an NDS application, the Company believes the regulatory review could be completed by mid-2024.
  • This is the second regulatory application for VLA1553 filed by Valneva, and the Company intends to make additional regulatory submissions in 2023.
  • A Biologic License Application (BLA) is currently under priority review1 by the U.S. Food and Drug Administration (FDA)2.
  • VLA1553 is currently the only chikungunya vaccine candidate worldwide for which regulatory review processes are underway and, if approved, it could become the first licensed chikungunya vaccine available to address this unmet medical need.

Acadia Pharmaceuticals Acquires Ex-North American Rights to Trofinetide and Global Rights to Neuren’s NNZ-2591 in Rett Syndrome and Fragile X Syndrome

Retrieved on: 
木曜日, 7月 13, 2023
Mental Health, Research, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Science, FBXW7 neurodevelopmental syndrome, NDS, ACAD, Rett syndrome, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., Fragile X syndrome, Patient, FDA, CGP, Pharmaceutical industry

Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) today announced that it has expanded its current licensing agreement for trofinetide with Neuren Pharmaceuticals to acquire ex-North American rights to the drug as well as global rights in Rett syndrome and Fragile X syndrome to Neuren’s development candidate NNZ-2591.

Key Points: 
  • Acadia Pharmaceuticals Inc. (NASDAQ: ACAD) today announced that it has expanded its current licensing agreement for trofinetide with Neuren Pharmaceuticals to acquire ex-North American rights to the drug as well as global rights in Rett syndrome and Fragile X syndrome to Neuren’s development candidate NNZ-2591.
  • In April of this year, Acadia launched trofinetide in the United States under the brand name DAYBUE as the first and only drug approved for the treatment of Rett syndrome.
  • “This expanded worldwide agreement solidifies Acadia's position as the global leader in addressing the unmet needs of people with Rett syndrome,” said Steve Davis, Acadia’s President and Chief Executive Officer.
  • Outside of North America, Neuren is eligible to receive additional payments for trofinetide upon the achievement of specified revenue milestones as follows:

Nordic Data Center Construction Market Outlook Report 2023-2028 Featuring Prominent Vendors - Arup, Caverion, Cowi, Designer Group, RED, and Granlund Group

Retrieved on: 
木曜日, 7月 6, 2023
Workforce, NDS, Meta, Green Mountain, Tele2, Mycelium, Net4Mobility, Electricity, Neptec Design Group, Telenor, Cold climate, Microsoft, Carbon, USD, Government, Hyperscale computing, Wind, Swedish government response to the COVID-19 pandemic, Wood, PUE, Investment, Engineering, Growth, PPA, AWS, RED, Renewable energy, Video game, Tissue paper, Baltic states, Nordic, Oracle, Telia

DUBLIN, July 5, 2023 /PRNewswire/ -- The "Nordic Data Center Construction Market - Industry Outlook & Forecast 2023-2028" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, July 5, 2023 /PRNewswire/ -- The "Nordic Data Center Construction Market - Industry Outlook & Forecast 2023-2028" report has been added to ResearchAndMarkets.com's offering.
  • Some major Nordic data center construction market vendors include companies Arup, Caverion, Cowi, Designer Group, RED, and Granlund Group.
  • What is the estimated market size in terms of area in the Nordic data center construction market by 2028?
  • How many MW of power capacity is expected to reach the Nordic data center construction market by 2028?

Nordic Data Center Construction Market Outlook Report 2023: Market to Reach a Value of Over $2.5 Billion by 2028 - Tax Incentives Boosting Data Center Construction - ResearchAndMarkets.com

Retrieved on: 
木曜日, 6月 29, 2023
Technology, Data Management, Workforce, NDS, Meta, Green Mountain, Tele2, Mycelium, Net4Mobility, Electricity, Neptec Design Group, Telenor, Cold climate, Microsoft, Carbon, USD, Government, Hyperscale computing, Wind, Swedish government response to the COVID-19 pandemic, Wood, PUE, Investment, Engineering, Growth, PPA, AWS, RED, Dietary supplement, Renewable energy, Video game, Tissue paper, Baltic states, Nordic, Oracle, Telia

The "Nordic Data Center Construction Market - Industry Outlook & Forecast 2023-2028" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Nordic Data Center Construction Market - Industry Outlook & Forecast 2023-2028" report has been added to ResearchAndMarkets.com's offering.
  • Some major Nordic data center construction market vendors include companies Arup, Caverion, Cowi, Designer Group, RED, and Granlund Group.
  • What is the estimated market size in terms of area in the Nordic data center construction market by 2028?
  • How many MW of power capacity is expected to reach the Nordic data center construction market by 2028?

MODERNA INITIATES ROLLING SUBMISSION TO HEALTH CANADA FOR UPDATED COVID-19 VACCINE

Retrieved on: 
木曜日, 6月 29, 2023
Vaccine, MRNA, NDS, Therapy, SARS-CoV-2, Biotechnology, COVID-19, RNA, Messenger, Moderna, Health Canada, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, XBB

TORONTO, June 29, 2023 /CNW/ - Moderna, Inc. (NASDAQ: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has initiated the filing of a rolling New Drug Submission (NDS) to Health Canada for its updated monovalent COVID-19 vaccine, SPIKEVAX® XBB.1.5 (mRNA-1273.815) targeting the omicron subvariant XBB.1.5 of SARS-CoV-2.

Key Points: 
  • TORONTO, June 29, 2023 /CNW/ - Moderna, Inc. (NASDAQ: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has initiated the filing of a rolling New Drug Submission (NDS) to Health Canada for its updated monovalent COVID-19 vaccine, SPIKEVAX® XBB.1.5 (mRNA-1273.815) targeting the omicron subvariant XBB.1.5 of SARS-CoV-2.
  • An updated vaccine will ensure Canadians have the most current and effective option to keep them protected.
  • We have initiated our submission with Health Canada and, pending approval, will be ready to supply an XBB monovalent vaccine in time for the fall," said Patricia Gauthier, President and General Manager, Moderna Canada.
  • Additionally, Moderna has generated preliminary clinical data of its monovalent XBB.1.5 vaccine candidate showing an immune response against XBB descendent sublineages such as XBB.1.5, XBB.1.16, and XBB.2.3.2.

European Data Center Construction Industry to 2028: 5G Deployments Fuelling Data Center Investments

Retrieved on: 
月曜日, 6月 12, 2023
DPR Construction, Turner & Townsend, Electricity, Tax, Microsoft, Investment, Artificial intelligence, G20, RED, NDS, Mercury, AECOM, Vodafone UK, Research, USD, Organization, Cloud computing, Eurostat, National Strategy for Inner Areas, Growth, OEM, Dell, Meta, Green Mountain, Neptec Design Group, Government, Oracle Communications Messaging Server, Engineering, GDPR, HPE, VAT, Internet of things, Intelligence, Wind, Developed country, Huawei, HPC, City, Federal Act on Banks and Savings Banks, AWS, Pharmaceutical industry, Construction, Renewable energy, Video game, Medical device, Retail, Baltic states, Vertiv, Oracle

The growth in data center development has led to increased competition among data center contractors implementing new sustainable methods.

Key Points: 
  • The growth in data center development has led to increased competition among data center contractors implementing new sustainable methods.
  • Labor shortages, budget constraints, and construction delays in certain regions drive significant greenfield and modular data center development growth.
  • The rapid deployment of 5G networks in European countries drives investments in data centers, particularly edge data centers.
  • For example, Keysource provided planning, engineering, and construction services for edge data center construction at Namsos Datacenter (NDS).

Workforce 2025: DISA's investment to meet 'pacing challenges'

Retrieved on: 
木曜日, 6月 1, 2023
Workforce, Defense Information Systems Agency, Heart, NDS, Defense, National Defense Strategy (United States), Multimedia, United States Joint Forces Command, GEORGE, DISA, Knowledge, Loes, Arms industry, Management

In support of the 2022 National Defense Strategy workforce requirements and to achieve its mission of connecting and protecting the warfighter in cyberspace, DISA announces a new initiative called Workforce 2025, fundamentally shifting the agency's training, recruiting and retention efforts.

Key Points: 
  • In support of the 2022 National Defense Strategy workforce requirements and to achieve its mission of connecting and protecting the warfighter in cyberspace, DISA announces a new initiative called Workforce 2025, fundamentally shifting the agency's training, recruiting and retention efforts.
  • "If we focus solely on the technology required to do this and forget about the people who operate it, we will become stagnant and outpaced."
  • Workforce 2025 is divided into four lines of effort to meet the NDS' call to attract, train and promote a workforce that is equipped with the knowledge and decision-making abilities to creatively solve national security challenges in a complex global environment.
  • For more information about Workforce 2025, including the four LOEs, click here .

Health Canada Accepts New Drug Submission for Lecanemab as Treatment for Early Alzheimer's Disease

Retrieved on: 
火曜日, 5月 16, 2023
Priority review, The New England Journal of Medicine, Plaque, NDS, Alzheimer's disease, MHLW, Marketing, Neurotoxicity, Food, Advisory Committee, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, Lecanemab, Ministry of Health, Labour and Welfare, Brain, Medication, Pharmaceuticals and Medical Devices Agency, Oncology Drug Advisory Committee, EMA, Clarity, Ministry, Eisai, The Different Forms of Flowers on Plants of the Same Species, Prescription Drug User Fee Act, PMDA, National Medical Products Administration, Co-promotion, PDUFA, Ministry of Health (Kuwait), MAA, AD, FDA, Phase, Health Canada, BLA, NMPA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Disease, Medical imaging, Pharmaceutical industry, Biogen, Health

Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.

Key Points: 
  • Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease.
  • The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.
  • Lecanemab was approved under the accelerated approval pathway in the U.S. and was launched in the U.S. on January 18, 2023.

Health Canada Accepts New Drug Submission for Lecanemab as Treatment for Early Alzheimer’s Disease

Retrieved on: 
火曜日, 5月 16, 2023
Priority review, The New England Journal of Medicine, Plaque, NDS, MHLW, Marketing, Neurotoxicity, Food, Advisory Committee, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, Lecanemab, BIIB, Ministry of Health, Labour and Welfare, Brain, Pharmaceuticals and Medical Devices Agency, Medication, Oncology Drug Advisory Committee, EMA, Clarity, Ministry, The Different Forms of Flowers on Plants of the Same Species, Eisai, Prescription Drug User Fee Act, Headquarters, PMDA, National Medical Products Administration, Corporation, Co-promotion, PDUFA, Ministry of Health (Kuwait), MAA, AD, FDA, Phase, Health Canada, BLA, NMPA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Disease, Pharmaceutical industry, Biogen, Health

Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.

Key Points: 
  • Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease.
  • The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.
  • Lecanemab was approved under the accelerated approval pathway in the U.S. and was launched in the U.S. on January 18, 2023.

The American Association of Naturopathic Physicians to Celebrate Naturopathic Medicine Week, May 14-20

Retrieved on: 
金曜日, 5月 12, 2023
NDS, INM, Herbal medicine, Molina Healthcare, Public policy, Naturopathy, National University of Natural Medicine, United States Senate, US, Patient, Nature, Physician, Health, AANP, Pharmaceutical industry

WASHINGTON, May 12, 2023 /PRNewswire-PRWeb/ -- Naturopathic Medicine Week, an annual event held to promote the benefits of naturopathic medicine, is set to take place from May 14 to May 20, 2023. The week-long event aims to showcase the value of naturopathic medicine to patients, prospective patients, public policy makers, reporters, and community leaders through various creative activities, events, and messages.

Key Points: 
  • WASHINGTON, May 12, 2023 /PRNewswire-PRWeb/ -- Naturopathic Medicine Week , an annual event held to promote the benefits of naturopathic medicine, is set to take place from May 14 to May 20, 2023.
  • The origins of Naturopathic Medicine Week date back to 2013 when the US Senate unanimously passed S. Res.
  • The practice of naturopathic medicine includes modern and traditional modalities, and encompasses a range of therapies, including botanical and herbal medicine, nutritional medicine, lifestyle counseling, naturopathic physical manipulation, and much more.
  • The AANP encourages everyone to participate in Naturopathic Medicine Week 2023 and learn more about the benefits of naturopathic medicine.