McDonald’s Canada and its independent Franchisees are supporting communities impacted by the wildfires
WEBWIRE – Thursday, June 8, 2023
Across Alberta, Nova Scotia, and most recently, Quebec and Ontario, communities and individuals continue to grapple with the impact of wildfires. McDonalds independent Franchisees and restaurant teams have been hard at work supporting guests and restaurant team members in these impacted communities. We also know that some of our McDonalds Canada team members have been affected by the fires. And so, as we have for over 55 years, well rally together to support our local Franchisees, their teams, and communities in times of disaster.
Here is how Franchisees and their teams responded first and fast in times of crisis.
- Franchisee Peter MacIsaac supplied gift cards to any military personnel displaced by the fire in Halifax
- Franchisee Dave Murray donated 140 meals in the immediate aftermath and is making a $5,000 donation to the RMHC Halifax Walk in support of displaced families
- Franchisees Dave Murray, Mark Nelson and Bob Smith are teaming up to provide food to the Emergency Crews in Tantallon and Halifax. They have also reached out to local Fire Station in the community to drop off food as necessary and where possible
- Franchisee Stephanie Jones is contributing food and coffee to comfort centres and donating to the Red Cross
- Franchisee Tom Hickey has provided coffee to First Responders and local comfort centres
- Franchisees in Northern Alberta worked together to support residents displaced by evacuation order
McDonalds Canada is proud to remain committed to its partnership with the @CanadianRedCross and will make an additional donation towards relief efforts supporting affected communities and evacuees. To support the Red Cross and find information about support available, please visit their website, here.
Eisai Co., Ltd. and Biogen Inc. announced today that Health Canada has accepted a New Drug Submission (NDS) for lecanemab (brand name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Aβ) protofibril* antibody, for the treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) with confirmed amyloid pathology in the brain. The NDS is based on the results of the Phase III Clarity AD study and Phase IIb clinical study (Study 201), which demonstrated the lecanemab treatment showed a reduction of clinical decline in early AD. 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. In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer’s Disease (CTAD) Lecanemab was approved under the accelerated approval pathway in the U.S. and was launched in the U.S. on January 18, 2023. The accelerated approval was based on Phase II data that demonstrated that lecanemab reduced the accumulation of Aβ plaque in the brain, a defining feature of AD, and its continued approval may be contingent upon verification of lecanemab’s clinical benefit in a confirmatory trial. 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. In the U.S., Eisai submitted a supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway on January 6, 2023. On March 3, 2023, the FDA accepted Eisai’s sBLA based on the Clarity AD clinical data, and the lecanemab application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023. The FDA is planning to hold an Advisory Committee to discuss this application on June 9, 2023. In Japan, Eisai submitted an application for manufacturing and marketing approval to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023. Priority Review was granted by the Ministry of Health, Labour and Welfare (MHLW) on January 26, 2023. Eisai utilized the PMDA’s prior assessment consultation system, with the aim of shortening the review period for lecanemab. In Europe, Eisai submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) on January 9, 2023, which was accepted on January 26, 2023. In China, Eisai initiated submission of data for a BLA to the National Medical Products Administration (NMPA) of China in December 2022, and Priority Review was granted on February 27, 2023. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. *Protofibrils are large Aβ aggregated soluble species of 75-5000 Kd.(1) (1) Soderberg, L., Johannesson, M., Nygren, P. et al. Lecanemab, Aducanumab, and Gantenerumab – Binding Profiles to Different Forms of Amyloid-Beta Might Explain Efficacy and Side Effects in Clinical Trials for Alzheimer’s Disease. Neurotherapeutics (2022). https://doi.org/10.1007/s13311-022-01308-6. Accessed February 9, 2023 About Lecanemab Lecanemab (Brand Name in the U.S.: LEQEMBI) is the result of a strategic research alliance between Eisai and BioArctic. Lecanemab is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). In the U.S., LEQEMBI was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on January 6, 2023. LEQEMBI is indicated for the treatment of Alzheimer’s disease (AD) in the U.S. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in Aβ plaques observed in patients treated with LEQEMBI. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial. Please see full Prescribing Information in the United States: www.leqembi.com/-/media/Files/Leqembi/Prescribing-Information.pdf Eisai has completed lecanemab subcutaneous bioavailability study, and subcutaneous dosing is currently being evaluated in the Clarity AD OLE. Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer’s Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. The Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, has been ongoing since January 2022. About the Collaboration between Eisai and Biogen for AD Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority. About the Collaboration between Eisai and BioArctic for AD Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015. About Eisai Co., Ltd. Eisai’s Corporate Concept is “to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides.” Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology. In addition, our continued commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), is demonstrated by our work on various activities together with global partners. For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on Twitter, LinkedIn and Facebook. About Biogen Founded in 1978, Biogen is a leading global biotechnology company that has pioneered multiple breakthrough innovations including a broad portfolio of medicines to treat multiple sclerosis, the first approved treatment for spinal muscular atrophy, and two co-developed treatments to address a defining pathology of Alzheimer’s disease. Biogen is advancing a pipeline of potential novel therapies across neurology, neuropsychiatry, specialized immunology and rare diseases and remains acutely focused on its purpose of serving humanity through science while advancing a healthier, more sustainable and equitable world. The company routinely posts information that may be important to investors on its website at www.biogen.com. Follow Biogen on social media – Twitter, LinkedIn, Facebook, YouTube. Contacts:
Canada Asset Management Group’s recent opening of a research center in Toronto’s financial district, Exchange Tower, marks a significant milestone in the company’s history. The Hong Kong-based firm, founded in 2013, has decided to retrace its roots and expand its services to offer clients the highest quality research and analysis to maintain its position as a market leader in the financial industry. The company’s Chief Trading Director, Peter Jennings, emphasized the importance of the opening of the research center, by stating that it is a pivotal and special moment in the firm’s history. The new research center will now enable Canada Asset Management Group to better serve its clients and provide them with greater opportunities through financial instruments that are in line with their investment goals. With its prime location in Toronto’s financial district, the new research center will be able to tap into a wealth of resources and knowledge from the city’s financial community. The center will be staffed with experienced and qualified professionals who will be committed to providing clients with the most reliable and accurate analytical insights to make informed investment decisions. In summary, the launch of Canada Asset Management Group’s research center is a move towards providing its clients with the highest quality research and analysis, setting the company apart from its competitors as a leading player in the financial industry. Canada Asset Management Group is a reputable investment management firm that has been operating in the financial industry for several years. Over time, the company has grown significantly and has now achieved a remarkable milestone of having over 8000 clients worldwide, both institutional and private. This achievement is the direct result of the company’s successful investment recommendations and strategies, which have proved to be invaluable to its clients. Canada Asset Management Group takes a personalized approach towards investment management, tailoring its solutions to meet the specific goals and objectives of each of its clients. The firm has an experienced team of investment professionals who monitor and analyze market trends, economic indicators and individual company performance data. This enables the company to provide clients with well-informed investment advice and recommendations that are backed by comprehensive research and analysis. Canada Asset Management Group prides itself on its ability to deliver consistent performance results that exceed its clients’ expectations. The firm’s investment philosophy is rooted in a long-term, value-based approach to investing, which emphasizes the importance of patience, discipline, and sound judgment in achieving investment success.Japan – Health Canada Accepts New Drug Submission for Lecanemab as Treatment for Early Alzheimer’s Disease
conference, and simultaneously published in the New England Journal of Medicine, a peer-reviewed medical journal.Canada Asset Management Group Opens New Research Office in Toronto
Canada Asset Management Group
Andre Palmovka
+852 580 31615
www.canadaassetmanagement.com
Contact
Categories
- Investment