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
Special Olympics Airlift Takes Flight Nationwide; Dove 1 Arrives at St. Paul Downtown Airport19.6.2026 17:09:00 CEST | Press release
Approximately 130 Cessna, Beechcraft and Hawker aircraft and volunteer pilots mobilize to transport more than 800 Special Olympics athletes and coaches to the 2026 Special Olympics USA Games The 2026 Special Olympics Airlift officially took flight today as all participating Cessna, Beechcraft and Hawker aircraft, known as Doves, departed from airports across the country. Dove 1 for arrival day, a Cessna Citation Latitude generously operated by Prent Corporation, landed at St. Paul Downtown Airport (STP) carrying Special Olympic athletes and delegation members, signaling the start of Airlift arrivals for the Special Olympics USA Games. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260619085293/en/ Special Olympics Airlift takes flight nationwide; Dove 1 arrives at St. Paul Downtown Airport (Photo credit: Textron Aviation). The arrival signals the start of the world’s largest cumulative peacetime airlift spanning more than 40
Record Currency Management Participates in Innovative European Bank for Reconstruction and Development (EBRD) -Backed Mongolian Tugrik Transaction19.6.2026 16:53:00 CEST | Press release
Record Currency Management Ltd (RCM), subsidiary of London-listed Record plc (Record Financial Group), is pleased to announce its participation in an innovative local currency bond transaction issued by the European Bank for Reconstruction and Development (EBRD), supporting the development of Mongolia's capital markets while providing institutional investors with access to attractive frontier market opportunities. RCM is the UK currency management arm of Record Financial Group, the London-listed specialist investment group managing USD 115 billion of assets on behalf of institutional clients worldwide. Record's client base comprises pension funds, foundations, sovereign institutions and other asset managers, with whom the Group has built long-standing relationships through its focus on bespoke investment and risk management solutions. Headquartered in London, Record has offices in Hamburg, Zurich, Zug, New York, and Hong Kong. The investment forms part of Record Financial Group's broad
Plasma One Launches to Herald a New Era of Stablecoin Banking19.6.2026 14:29:00 CEST | Press release
Plasma has today announced the launch of Plasma One, its flagship financial product designed to make digital dollars usable for everyday spending, sending and earning. Plasma One is designed to make stablecoins feel like money, only better - more accessible, reliable and efficient. For years, stablecoin adoption has been held back by a fragmented system and poor user experience. We have seen wallets in one place, exchanges in another, and costly off-ramps standing between digital dollars and daily life. Plasma One brings that experience together in a single app, giving users a simple way to spend, send and earn with stablecoins from one account with zero fees. Headquartered in London, the city that gave rise to Revolut, Wise and Monzo, Plasma is making a bigger bet, that the next generation of consumer banking will be built on stablecoin rails, not legacy banking infrastructure. Underneath Plasma One is the Plasma Network, Plasma’s own blockchain, purpose-built to move stablecoins inst
IQM Appoints Craig Ciesla, Former Illumina VP, as CTO; Inés de Vega Becomes Chief Scientist19.6.2026 09:00:00 CEST | Press release
Ciesla is a seasoned deep tech executive with more than 25 years of experience delivering products across industries — from startups to Fortune 500 companies. De Vega brings more than 20 years of experience advancing quantum technologies from fundamental research to intellectual property and industrial applications. IQM Quantum Computers, the global leader in superconducting quantum computers, today announced the appointments of Dr. Craig Ciesla as Chief Technology Officer (CTO) and Dr. Inés de Vega as Chief Scientist, as she transitions from her role as Vice President of Quantum Solutions, deepening IQM´s leadership as the company prepares for its planned Nasdaq listing through a merger with Real Asset Acquisition Corp. (Nasdaq: RAAQ). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260619693929/en/ From left to right: Dr. Inés de Vega, Chief Scientist, and Dr. Craig Ciesla, Chief Technology Officer. Ciesla, an experienced d
Teijin Receives Approval for Additional Indications of XEOMIN® for Cervical Dystonia and Blepharospasm in Japan19.6.2026 09:00:00 CEST | Press release
Teijin Pharma Limited, the core company of the Teijin Group’s healthcare business, and Merz Therapeutics GmbH, a leading player in neurology-focused specialty pharma, jointly announced today that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved the additional indications for XEOMIN® (incobotulinumtoxinA) for the treatment of cervical dystonia and blepharospasm. This approval represents the fourth and fifth indications for XEOMIN® authorized in Japan, alongside its existing approvals for the treatment of upper limb spasticity, lower limb spasticity and chronic sialorrhea. Cervical dystonia is a focal dystonia characterized by involuntary contractions of the neck muscles, resulting in abnormal or repetitive movements and postures.1 Blepharospasm is also a focal dystonia, characterized by excessive involuntary contractions of the muscles surrounding the eye.2 Both conditions significantly impact patients’ quality of life. The approval by MHLW is based on Phase III clinic
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