MEDICAGO
Medicago, a biopharmaceutical company headquartered in Quebec City, is pleased to announce submission of the positive Phase 3 data for regulatory review by Health Canada as part of the New Drug Submission for COVID (NDS-CV) rolling review for Medicago’s COVID-19 vaccine candidate combined with GSK’s pandemic adjuvant. Medicago is seeking review and approval for the vaccine candidate for indication in healthy adults, aged 18 years and above.
“We are pleased to submit our Phase 3 data as the final portion of the rolling submission for our COVID-19 vaccine candidate for review,” said Dr. Judith Atkins, Vice-President of Regulatory Affairs at Medicago. “We are grateful to Health Canada for their review, and we hope this brings Canadians and the world one step closer to having greater vaccine diversity.”
Thomas Breuer, Chief Global Health Officer, GSK, added: “We are one step closer to our goal of making this innovative adjuvanted, plant-based vaccine available. As a refrigerator-stable option that builds on our established adjuvant technology, we are hopeful it will play an important role in the efforts to overcome the COVID-19 pandemic.”
The New Drug Submission for COVID (NDS-CV) process allowed the submission of nonclinical sections, quality, clinical safety, and efficacy information as they became available for Health Canada’s immediate review to accelerate the overall review process. Submitting the Phase 3 data completes the submission process.
The regulatory filing process for the COVID-19 vaccine candidate has been initiated with the FDA (US) and MHRA (UK). Preliminary discussion is underway with the WHO for preparation of the submission. A Phase 1/2 trial has also been initiated in Japan where Medicago plans to submit for regulatory approval in combination with the Phase 2/3 global study results next spring. The vaccine candidate has not yet been approved by any health authorities.
“If authorized, Medicago’s COVID-19 vaccine would be the world’s first ever plant-based vaccine approved for human use,” said Takashi Nagao, CEO and President of Medicago. “It would also be the first Canadian vaccine approved in over 20 years, signaling a powerful step forward for Canada’s vaccine preparedness strategy.”
About Medicago
Medicago is on a mission to help improve global public health using the power of plants. Founded in 1999 with the belief that innovative approaches and rigorous research would bring new solutions in healthcare, Medicago is a pioneer in plant-based therapeutics. We are proudly rooted in Quebec, with manufacturing capacity in both Canada and the US. Our passionate and curious team of over 500 scientific experts and employees are dedicated to using our technology to provide rapid responses to emerging global health challenges, and to advancing therapeutics against life-threatening diseases worldwide. Medicago is an affiliated company of Mitsubishi Tanabe Pharma Corporation. For more information: www.medicago.com
About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation (MTPC) Group, the majority parent company of Medicago, is one of the large Japanese pharmaceutical companies, with its headquarters in Osaka, Japan. It positions vaccines as one of its key R&D areas under its Medium-Term Management Plan 21-25 and is also working to develop new modalities of vaccines. MTPC Group will further contribute to the prevention of infectious diseases which is one of the world’s important social issues, by delivering a new option of plant-based VLP vaccine as a new type of vaccine. For further information please visit https://www.mt-pharma.co.jp/e/ .
View source version on businesswire.com: https://www.businesswire.com/news/home/20211216005780/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Lattice Wins 2025 Global Semiconductor Alliance Award6.12.2025 00:49:00 CET | Press release
‒ Named Most Respected Public Semiconductor Company Achieving $100 Million to $500 Million in Annual Sales ‒ Lattice Semiconductor (NASDAQ: LSCC), the low power programmable leader, today announced that it was selected as ‘Most Respected Public Semiconductor Company’ at the 2025 Global Semiconductor Alliance (GSA) Awards. The GSA awards recognize companies that have demonstrated excellence through their success, vision, strategy, and future opportunities in the industry as determined by votes from GSA members. “We are honored to be recognized by the Global Semiconductor Alliance and our peers as one of 2025’s most respected public semiconductor companies. This recognition reflects the dedication of the Lattice team and the trust of our customers, partners, suppliers, and investors. Looking ahead, we remain laser-focused on driving innovation and strengthening our role as the trusted low power programmable leader for semiconductor and system solutions,” said Ford Tamer, Chief Executive
Andersen Consulting udvider sine kapaciteter inden for digital transformation5.12.2025 16:53:00 CET | Pressemeddelelse
Andersen Consulting indgår en samarbejdsaftale med Neit Consulting, et firma med fokus på at skabe mere effektiv drift, integrere intelligente teknologier og accelerere den digitale modenhed for kunder. Neit Consulting er et konsulentfirma med base i Tjekkiet og mere end 20 års erfaring med at levere ISO-certificerede it- og forretningsrådgivningsydelser inden for dataanalyse, performance management og procesoptimering. Med mere end 200 konsulenter hjælper firmaet kunder – herunder globale banker, forsikringsselskaber, produktionsvirksomheder og offentlige instanser –gennem virksomhedsrådgivning, implementering af it-systemer og langsigtet systemsupport. Neit Consulting betjener kunder internationalt med fokus på at afstemme digital kapacitet med komplekse driftsmæssige behov. "Dette samarbejde afspejler et markant fremskridt i omfanget af de ydelser, vi tilbyder vores kunder," udtaler Tomáš Niederle, salgsdirektør for Neit Consulting. "Andersens globale rækkevidde og tværfaglige tilga
Fitch Learning Completes Acquisition of Moody’s Analytics Learning Solutions and the Canadian Securities Institute5.12.2025 16:48:00 CET | Press release
Combined entity to accelerate financial services skills development and drive measurable business outcomes across 148 countries Fitch Learning, the global leader in financial learning and professional certifications, today announced the completion of its acquisition of Moody’s Analytics Learning Solutions (MALS) and the Canadian Securities Institute (CSI). MALS is a global provider of credit and digital learning, and CSI is a leading provider of certifications for the Canadian financial services industry. Fitch Learning, recognized globally as the premier financial education provider, delivers specialized training for the financial services industry through accredited qualifications, flexible corporate solutions programs, managed services and digital learning solutions trusted by leading institutions worldwide. The combined business will serve over 92,000 finance professionals across 148 countries, at every stage of their careers. “This acquisition is about creating more opportunities
Arthur D. Little and Vega IT Unveil Joint Venture for Digital Innovation5.12.2025 16:00:00 CET | Press release
Arthur D. Little (ADL) and Vega IT today announced the formation of Axceler8 Solutions, a 50/50 joint venture created to design, develop, and operate a portfolio of digital and AI solutions aimed at improving efficiency and automating complex business processes. The launch of this new company is the direct outcome of a year of successful collaboration between the two firms and marks a new phase in their shared ambition to bring scalable, high-performance digital solutions to market, aiming to further augment their clients’ capacity to compress time to impact in a variety of domains. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251205465303/en/ Arthur D. Little and Vega IT have announced the formation of Axceler8 Solutions, a 50/50 joint venture created to design, develop, and operate a portfolio of digital and AI solutions. Axceler8 Solutions’ first product, Axceler8 Rx, is now live as a newly developed platform, and is a
Lone Star Announces Sale of SPX FLOW to ITT Inc.5.12.2025 13:30:00 CET | Press release
Lone Star Funds (“Lone Star”) today announced the signing by an affiliate of Lone Star Fund XI, LP of a definitive agreement to sell SPX FLOW, Inc. (“SPX FLOW”), a leading provider of highly engineered equipment and process technologies for attractive end markets including industrial, health and nutrition, to ITT Inc. (NYSE: ITT) for $4.775 billion in cash and shares of common stock. Based in Charlotte, N.C., SPX FLOW focuses on process technologies delivering mixing, blending, fluid handling, separation, thermal heat transfer and other solutions integral to industrial, health and nutrition markets. The company has operations in more than 25 countries and sales in more than 140 countries. In partnership with Lone Star, SPX FLOW has focused on improving its sales execution and operating platform, while ensuring high quality and innovative product development. The management team has improved the company’s commercial organization and executed growth initiatives to build its presence in e
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom