MEDICAGO
16.12.2021 20:02:09 CET | Business Wire | Press release
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
Hitachi Announces Strategic Partnership With Anthropic to Strengthen "Lumada 3.0" Through Frontier AI19.5.2026 02:00:00 CEST | Press release
Combining Hitachi’s 110+ years of domain expertise with frontier AI will advance safe real-world deployment of physical AI and strengthen customer AI transformation Deploying advanced AI across all business processes for approximately 290,000 employees to enhance productivity at scale Developing 100,000 AI professional talent and co-creating new HMAX solutions leveraging proven outcomes from Hitachi’s “Customer Zero” approach Establishing the “Frontier AI Deployment Center,” a global organization spanning North America, Europe, and Asia with an initial team of 100 experts Hitachi, Ltd. (TSE:6501, "Hitachi") today announced a strategic partnership with Anthropic PBC (“Anthropic”), a global leader in AI safety research and trusted AI models, to further strengthen the “Lumada 3.0” business model. As artificial intelligence evolves beyond cyberspace to directly influence real-world systems—otherwise known as physical AI—demand is rapidly growing for the safe and seamless deployment of AI i
Moore Nanotechnology Systems (Nanotech) Will Be Acquired by Shibaura Machine Group to Form a New Ultra-Precision Machine Tool Organization18.5.2026 21:36:00 CEST | Press release
MOORE NANOTECHNOLOGY SYSTEMS (“Nanotech”), today announced that it is being acquired by an affiliate of SHIBAURA MACHINE CO., LTD., an industrial machine-tool manufacturer headquartered in Japan. Founded nearly 30 years ago by Len Chaloux and Newman Marsilius III as a standalone subsidiary of the Moore Tool Company, Inc., Nanotech has become a global leader in the design, development and manufacture of state-of-the-art ultra-precision machine tools and associated processes for the production of advanced optical and reflective components. “As the world’s markets continue to develop, finding the right strategic partnerships is essential,” said Mark Boomgarden, President and CEO of Nanotech. “Partnering with Shibaura allows us to combine the true competencies of both organizations under one management team - affording both companies the ability to scale resources and invest on a global stage like never before.” Co-owner Newman Marsilius IV shared, “Moore Nanotechnology Systems grew to a p
First Guests Arrive at Four Seasons Resort and Residences Red Sea at Shura Island from 20 May, as Red Sea Global Launches First JV Resort18.5.2026 20:06:00 CEST | Press release
RSG and Kingdom Holding Company bring first joint venture-developed resort at The Red Sea to market Red Sea Global (RSG), the regenerative tourism developer, has reached a major milestone as Four Seasons Resort and Residences Red Sea at Shura Island welcomes first guests from 20 May, marking the first joint venture-developed resort within its portfolio to enter the market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260518349628/en/ An aerial view of Four Seasons Resort and Residences at Shura Island, set along the shoreline with clear views of the Red Sea. Developed in partnership with Kingdom Holding Company (KHC), the launch represents a shared milestone for both organizations and marks a new phase in RSG’s development model, highlighting the growing role of institutional and private sector partnerships in scaling Saudi Arabia’s luxury tourism sector. “With Four Seasons preparing to welcome guests, we are significantly
Belkin Advances Towards Carbon Neutrality in Scope 3 Emissions18.5.2026 18:10:00 CEST | Press release
The company’s 2025 Impact Report highlights its continued progress in emissions reduction, circular design, and responsible packaging Belkin, a leading consumer electronics brand for 40 years, published its 2025 Impact Report, highlighting key achievements and reaffirming its commitment to corporate responsibility. Having achieved carbon neutrality in scope 1 and scope 2 emissions in 2025, the company continues to advance toward scope 3 carbon neutrality through enhanced life cycle assessment capabilities and improved supplier and logistics data collection. In 2025, Belkin calculated 131 product carbon footprints across its portfolio, surpassed 21.6 million PCR products sold, and has achieved a 95% reduction in single-use plastic packaging since 2019, reflecting continued progress in carbon reduction and responsible product design. “As we continue to make progress against our sustainability goals, we are taking deliberate steps to reduce our impact,” said Steven Malony, CEO of Belkin.
Infobip Named a Leader in the 2026 Gartner® Magic Quadrant™ for Communications Platform as a Service18.5.2026 16:25:00 CEST | Press release
Recognized for Completeness of Vision and Ability to Execute Infobip is excited to share that global AI-first cloud communications platform Infobip has been recognized as a Leader in the 2026 Gartner Magic Quadrant for Communications Platform as a Service. Check back for a complimentary copy of the full report soon! In Infobip’s view, this recognition reflects what the company has spent 20 years building: a communications platform that stays focused on what customers actually need and evolves as markets change. Infobip believes that recognition in a fast-moving market comes not from chasing trends, but from disciplined execution and a clear long-term vision. As Infobip marks its 20th year of operations, the company thinks the shift to agentic AI represents the most significant transformation in customer communications in our history. Infobip believes enterprises need a partner that empowers them to move from campaigns and rigid workflows to autonomous, goal-driven interactions, while r
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