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
Europe’s Original First Check Investor Seedcamp Raises $320 Million22.6.2026 11:23:00 CEST | Press release
First backer of Revolut, Wise, UiPath, Synthesia and Fluidstack brings nearly two decades of experience and conviction to Europe’s next frontier Expands US team to support founders building global giants from day one Raise is split across a $220m Core fund and $100m Select fund to back winners through Series B and beyond Backing founders at the very beginning - before the company or the theme is obvious Seedcamp, Europe’s original first check investor and earliest backer of companies including Revolut, Wise, UiPath, Synthesia and Fluidstack, has raised $320 million to invest in the next generation of global companies. US expansion for born global founders and early growth capital for portfolio winners Since launching in 2007 with a $2.5m first fund, Seedcamp now manages over $1bn in AUM and has delivered some of the strongest venture fund returns in Europe. Seedcamp Fund III has now returned over 13x DPI to its Limited Partners, and Fund IV sits at over 5x net TVPI. The new capital is
Navan Invests in European Footprint with New Partnerships22.6.2026 10:01:00 CEST | Press release
New integrations with ITA Airways, Caledonian Sleeper, and Virtuo elevate localized inventory across Europe Navan (NASDAQ: NAVN), the global AI-powered business travel and expense platform, today announced new integrations with European travel suppliers. Navan will add to its platform a direct New Distribution Capability (NDC) connection with Italy’s national air carrier, ITA Airways; overnight rail services in the UK with Caledonian Sleeper; and mobile-first car rental bookings in France with Virtuo. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260622904121/en/ New integrations with ITA Airways, Caledonian Sleeper, and Virtuo elevate localized inventory across Europe “We’re seeing incredible momentum across Europe, bookings to and from the continent are up year-over-year, and to truly serve the European market you have to continually invest locally,” said Michael Riegel, Chief Customer Officer at Navan. “By bringing ITA’s
Finalists Announced for the Second Edition of the Reply AI Music Contest, the International Competition Exploring the Relationship Between AI and Live Performance22.6.2026 10:00:00 CEST | Press release
The jury will announce the winners on Saturday, 4 July, on the stage of Kappa FuturFestival in Turin Music and artificial intelligence come together at the Reply AI Music Contest to explore the relationship between AI and live performance. The competition, created by Reply and organized in collaboration with Kappa FuturFestival — one of Europe’s leading festivals dedicated to electronic music and cultural innovation — announces the five finalists selected by an international jury of professionals from music and creative industries: Agoria, Max Cooper, Fleur Shore, Tini Gessler, Ali Demirel, Albi Scotti, Oliver Bohl and Sarah Grimaldi. The finalists represent a new generation of innovators using AI to explore new forms of integration between sound, visual arts and live performance. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260622111182/en/ Finalists announced for the second edition of the Reply AI Music Contest, the inte
Zilliz Launches Vector Lakebase, Extending the World's Most Adopted Vector Database into a Unified Data Platform for AI22.6.2026 08:00:00 CEST | Press release
Available now in public preview on Zilliz Cloud, Vector Lakebase keeps production vector search at its core and adds shared lake-native storage and on-demand compute — bringing real-time serving, interactive discovery, and batch analytics onto one data foundation. Zilliz, the company behind Milvus, the world's most widely adopted open-source vector database, today announced the public preview of Zilliz Vector Lakebase, a major Zilliz Cloud release that pairs the production vector database with a shared, lake-native data foundation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260621822926/en/ Vector Lakebase keeps Zilliz Cloud's real-time vector search at the core — the engine Zillow, OpenEvidence, Exa, Filevine, MiniMax, and more than 10,000 enterprises and AI teams already rely on — and extends it with three new ways to operate on the same data: interactive discovery, large-scale batch analytics, and search directly on e
Andersen Global styrker sin tilstedeværelse i Indien med JMP Advisors21.6.2026 16:16:00 CEST | Pressemeddelelse
Andersen Global indgår en samarbejdsaftale med JMP Advisors i Indien og tilføjer skattemæssig ekspertise til virksomhedens eksisterende juridiske kapaciteter i landet. JMP Advisors tilbyder rådgivning inden for skat, lovgivning og transaktioner til både nationale og multinationale klienter, der opererer i komplekse forretningsmiljøer i konstant udvikling. Firmaet leverer ydelser, der spænder over international og indisk skat, transfer pricing, international strukturering, rådgivning om udenlandske investeringer, transaktionsstøtte, generationsskifteplanlægning og regulatoriske forhold. Dets klienter omfatter multinationale selskaber, vækstvirksomheder, virksomheder støttet af kapitalfonde og venturekapital samt formuende privatpersoner og familier. "Vores fokus har altid været at levere klar og handlingsorienteret vejledning, der hjælper kunder med at navigere i komplekse situationer og drive deres virksomhed med en tydelig kurs," udtalte Jairaj Purandare, grundlægger og formand for JM
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