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
Echodyne Opens New Manufacturing Facility to Meet Surging Global Demand for Advanced MESA® Radar9.7.2026 15:00:00 CEST | Press release
New Washington State facility provides capacity to manufacture more than 30,000 radars annually, strengthening the U.S. defense industrial base As governments around the world accelerate investment in counter-unmanned aircraft systems (C-UAS) and short-range air defense, Echodyne today announced the opening of a new advanced radar manufacturing facility in Washington State, significantly expanding its manufacturing capacity to meet rapidly growing demand from U.S. and allied customers. With millions of drones manufactured and used by both sides in the Russian War in Ukraine, the need for enhanced safety for defense, national security, and critical infrastructure assets grows with every successful strike and interception. The low cost and high utility of drones dramatically alters the need for safety and security sensors. And as the low altitude economy takes off, hundreds of thousands of drones will perform a range of life-saving and commercial missions, requiring a sensor infrastructu
Orca Security Report: 99.9% of Fixable AI Vulnerabilities Remain Unpatched as AI Moves Into Production9.7.2026 15:00:00 CEST | Press release
Analysis of more than 1,200 production cloud environments provides a first-hand view into how organizations are embedding AI into business-critical workflows, exposing new security risks that traditional controls weren't built to address. Orca Security, a leader in cloud and AI security, today released its 2026 State of AI Security Report, offering a first-hand view into how AI is being deployed across more than 1,200 production cloud environments. The findings show AI is no longer limited to isolated pilots or developer experiments. Organizations are embedding AI into production applications, cloud services, and autonomous workflows faster than security programs can adapt. More than half (56%) of organizations have already deployed AI agents into production, while 51% use AI to build custom applications. At the same time, Orca found that 81% of organizations run vulnerable AI packages, and 99.9% of fixable AI vulnerabilities remain unpatched, highlighting how quickly AI has become ope
Viz.ai Expands into Neurodegenerative Disease with Cortechs.ai Collaboration9.7.2026 15:00:00 CEST | Press release
Cortechs.ai and Viz.ai partner to tackle multiple sclerosis and other neurodegenerative diseases across Viz.ai's health system network Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced a collaboration with Cortechs.ai, a global leader in neuroimaging and quantitative analysis solutions, to integrate Cortechs.ai's NeuroQuant and NeuroQuant MS suite into the Viz.ai platform, expanding access to quantitative neuroimaging for hospitals and health systems across the U.S. This partnership marks Viz.ai's expansion into neurodegenerative disease, growing Viz Neuro Suite beyond its already market-leading neuro offerings. The collaboration will begin with a focus on multiple sclerosis (MS), integrating quantitative MRI analysis from NeuroQuant MS directly into Viz.ai's care coordination workflow, giving clinicians both the quantitative precision and the coordination infrastructure needed to identify and manage MS patients at scale. “Viz.ai's co
SCP Standard Capital Partners AG: Fabian Becker Appointed Chairman of the Management Board and CEO9.7.2026 14:51:00 CEST | Press release
The Supervisory Board of SCP Standard Capital Partners AG (WKN: A12UPJ | ISIN: DE000A12UPJ7 | XETRA ticker: CAP) resolved today to appoint Mr. Fabian Becker as Chairman of the Management Board and Chief Executive Officer (CEO), effective as of 9 July 2026. Ms. Stephanie Schettler-Köhler will remain a member of the Management Board and will assume the role of Chief Operating Officer (COO). View source version on businesswire.com: https://www.businesswire.com/news/home/20260709982268/en/
Teva and Polpharma Biologics Announce Global Licensing Agreement for a Biosimilar Candidate to Ocrevus® (ocrelizumab) for Multiple Sclerosis9.7.2026 14:45:00 CEST | Press release
Teva secures exclusive global rights to commercialize Polpharma Biologics’ biosimilar candidate to Ocrevus® (ocrelizumab), including both intravenous and subcutaneous formulations.Agreement advances Teva’s Pivot to Growth strategy by expanding its biosimilars pipeline through strategic collaborations.Agreement reflects both companies’ commitment to broadening access to biologic medicines. Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd (NYSE: and TASE: TEVA) and Polpharma Biologics International AG today announced a global licensing agreement granting Teva exclusive rights to commercialize both formulations of Polpharma Biologics’ proposed biosimilar to Ocrevus®1 (ocrelizumab), upon regulatory approval. This strategic agreement is expected to combine Polpharma Biologics’ proven biosimilar development expertise with Teva’s commercial footprint and capabilities. This press release features multimedia. View the full release here: https://www.bus
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