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
2026 NAB Show Opens Tomorrow, Uniting Global Media Leaders to Shape the Future of Storytelling18.4.2026 04:08:00 CEST | Press release
CEO of Zhong, one of YouTube’s most-watched creators with 70 million subscribers and 95 million followers on all platforms, joins program The 2026 NAB Show kicks off Saturday, April 18, with the show floor and exhibits opening on April 19, highlighting the most innovative companies and bringing together the world’s most influential voices across media, entertainment and technology for the industry’s premier global event. As the only platform that convenes broadcasters, media companies, content creators and technology innovators at scale, NAB Show continues its century-long legacy as the catalyst for innovation, growth and deal-making in a rapidly evolving, multi-platform world. From artificial intelligence and the creator economy to sports, streaming and cloud transformation, NAB Show is where the tools, talent and ideas driving the future of storytelling converge. “NAB Show is where the global media ecosystem comes together not just to explore what’s next—but to build it,” said Karen
Philip Morris International Announces U.S. FDA Reauthorization of IQOS as a Modified Risk Tobacco Product17.4.2026 23:43:00 CEST | Press release
A pioneer in smoke-free tobacco products, Philip Morris International is the only company that has received modified risk tobacco product authorizations for heated tobacco products.In their order, FDA concluded that: “Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals” The U.S. Food and Drug Administration (FDA) announced that it has authorized the renewal of modified risk tobacco product (MRTP) orders previously granted to PMI for two versions of the IQOS device and three variants of the tobacco consumables, commercialized under the HEETS brand. This renewal allows PMI to continue sharing reduced-exposure information with U.S. adults 21+ who use traditional tobacco products, such as combustible cigarettes. The agency concluded that renewing the IQOS and HEETS MRTP authorizations is appropriate to promote public health and is expected to benefit th
Canva Announces Anthropic Collaboration to Bring AI-Powered Design to Millions17.4.2026 17:51:00 CEST | Press release
New collaboration brings Canva into Claude Design by Anthropic, turning AI-generated ideas into fully editable, on-brand designs Canva, the world’s leading all-in-one visual communication platform, today announced the next chapter in its two-year strategic collaboration with Anthropic, bringing Canva directly into the newly launched Claude Design by Anthropic Labs, one day after unveiling Canva AI 2.0 to a crowd of 6,500 people at Canva Create in Los Angeles.. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260410843169/en/ Canva and Claude Canva is also today introducing HTML importing, a new capability that makes it easy to bring interactive content generated in tools like Claude into the Canva editor for drag-and-drop collaboration, refinement, and publishing. The collaboration makes it easier for Claude Design users to turn AI-generated drafts and ideas into fully editable designs in Canva, where they become collaborative
Andersen Consulting tilføjer samarbejdsfirmaet Nuvolar17.4.2026 15:43:00 CEST | Pressemeddelelse
Andersen Consulting udvider sin platform for digitale transformation gennem en samarbejdsaftale med Nuvolar, et teknologikonsulenthus med speciale i cloudbaseret softwareudvikling og avancerede Salesforce-implementeringer. Nuvolar, der blev stiftet i 2008 og har hovedsæde i Spanien, leverer end-to-end digital produktudvikling med dyb ekspertise inden for Salesforce, specialudviklede web- og mobilapplikationer, full-stack udvikling, UX/UI-design, produktledelse og langsigtede supporttjenester. Med mere end 110 fagfolk fordelt over Barcelona, Madrid, Miami og Mexico City arbejder virksomheden med kunder inden for luftfart, sundhedsvæsen, forbrugsgoder, medicinalindustrien samt hotel- og restaurationsbranchen for at designe og implementere skalerbare, forretningskritiske platforme, der optimerer driften og fremskynder den digitale transformation. "Samarbejdet med Andersen Consulting giver os mulighed for at levere vores ekspertise i en større skala," udtalte Marc Vivas, administrerende di
Qualcomm Announces Quarterly Cash Dividend17.4.2026 15:00:00 CEST | Press release
Qualcomm Incorporated (NASDAQ: QCOM) today announced a quarterly cash dividend of $0.92 per common share, payable on June 25, 2026, to stockholders of record at the close of business on June 4, 2026. About Qualcomm Qualcomm relentlessly innovates to deliver intelligent computing everywhere, helping the world tackle some of its most important challenges. Building on our 40 years of technology leadership in creating era-defining breakthroughs, we deliver a broad portfolio of solutions built with our leading-edge AI, high-performance, low-power computing, and unrivaled connectivity. Our Snapdragon® platforms power extraordinary consumer experiences, and our Qualcomm Dragonwing™ products empower businesses and industries to scale to new heights. Together with our ecosystem partners, we enable next-generation digital transformation to enrich lives, improve businesses, and advance societies. At Qualcomm, we are engineering human progress. Qualcomm Incorporated includes our licensing business
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