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
Saudi Fund for Development Announces Progress on Pristina–Mitrovica Highway Project in Kosovo13.10.2026 15:36:00 CEST | Press release
The Saudi Fund for Development (SFD) today joined the Government of Kosovo to inaugurate the Pristina–Mitrovica Highway, marking SFD’s first completed project in Kosovo and an important milestone in the partnership between both sides. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261013433726/en/ SFD CEO and Kosovar's minsters sideline meeting (Photo: AETOSWire) His Excellency Sultan bin Abdulrahman Al-Marshad, Chief Executive Officer of the Saudi Fund for Development, inaugurated the upgraded highway section by cutting the ribbon at the newly completed road. He subsequently held a sideline meetings with His Excellency Hekuran Murati, Minister of Finance, His Excellency Dimal Basha Minister of Infrastructure and Transport, and His Excellency Arben Vitia, Minister of Health, to discuss the development projects and the continued SFD- Kosovo partnership. The project upgrades a 9.87 km section of the Prishtina–Mitrovica Highway
KAST Selects Kiln’s Claire Wells as Chief Legal Officer13.10.2026 15:30:00 CEST | Press release
KAST adds an experienced CLO to help drive the next phase of growth The hire further enhances KAST’s robust compliance function Wells is leading the charge to add additional licenses throughout the world KAST, the global money app, announced today that Claire Wells has joined the company as Chief Legal Officer. Wells will lead KAST’s global legal operations, and the company’s compliance, regulatory, fundraising and licensing initiatives are under her remit. Wells is a proven legal and compliance leader with deep experience building and scaling legal, regulatory and policy functions across fintech, payments and digital assets. She has navigated complex, multi-jurisdictional environments, all while delivering growth. “I’m thrilled that Claire has joined the KAST team as our new Chief Legal Officer,” said KAST Founder & CEO Raagulan Pathy. “Claire is joining us at a truly pivotal time for the company as we enter our next phase of growth. We are continuing to expand our product set rapidly
Ohana Development Announces Erling Haaland as a Proud Homeowner at Manchester City Yas Residences by Ohana, During Phase 2 Launch13.10.2026 15:00:00 CEST | Press release
Pep Guardiola announced as official brand ambassador of the project Ohana Development has announced Erling Haaland as a proud homeowner at Manchester City Yas Residences by Ohana during the launch of the project’s second phase. Featuring two- and three-bedroom townhouses, duplex villas, and four- and five-bedroom villas, Phase 2 sales will commence on 19 October 2026. The event at Etihad Arena welcomed over 4,000 guests, including Pep Guardiola, who was announced as the project’s official brand ambassador. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261013790618/en/ Manchester City Yas Residences by Ohana Launches Phase 2 (Photo: AETOSWire) Located along Yas Canal, adjacent to Yas Island, the development spans 1.67 million square metres and will feature more than 2,000 residences. The world’s first Manchester City-branded residential community has already broken ground, with phased delivery scheduled by 2029. In a video a
Tigo Energy Enables over 11MW of Repowering as Legacy Solar Service Market Grows13.10.2026 15:00:00 CEST | Press release
New repowering playbook and installer resources pair step-by-step business guidance with technical training and inverter flexibility for legacy-system upgrades. Tigo Energy, Inc. (NASDAQ: TYGO) (“Tigo” or “Company”), a leading provider of intelligent solar and energy software solutions, today announced that Tigo technology has helped enable over 11MW of solar repowering projects as demand grows for upgrades, replacement components, and services across the installed base of aging residential solar systems. To help installers capture this opportunity, Tigo is also introducing a practical repowering playbook and installer resources designed to support both business development and the technical execution of legacy-system upgrades through repowering. The Tigo Repowering Business Playbook gives installers a step-by-step framework for building a repowering business across four stages: Discover, Build, Sell, and Grow. The guide addresses how to evaluate the market opportunity, create repeatab
Xsolla Announces Direct Co-Marketing Campaigns Between Payment Providers and Video Game Developers13.10.2026 15:00:00 CEST | Press release
Providers Will Soon Be Able To Launch Co-Marketing Campaigns, Such As Cashback For Their Payment Method, In Xsolla Pay Station, Directly From Their Account Xsolla, a global commerce company, today unveiled plans for Co-Marketing Campaigns, an upcoming self-serve tool in Xsolla Business Account for Payment Providers that lets payment providers initiate and manage marketing campaigns directly with video game developers. Xsolla will preview it at Money20/20 USA in Las Vegas, October 18 - 21, 2026, in meeting room Veronese 2505. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261013246989/en/ Graphic: Xsolla Video games drive major consumer spending, but payment providers that process many of those payments have had limited ways to participate in the marketing and engagement opportunities that follow. With access to more than 1,500 video game developers and their players, Xsolla will help payment providers turn payment insights i
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