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
Aqara Announces the Availability of The Spatial Multi-Sensor FP400, Offering Advanced Spatial Intelligence for Smart Homes16.9.2026 09:00:00 CEST | Press release
Aqara, a global leader and pioneer in IoT, today announced the release of the Spatial Multi-Sensor FP400. The FP400 is designed to bring precise, spatial intelligence to homes without sacrificing the privacy typically compromised by smart cameras. Rather than simply detecting motion or presence, the FP400 enables homes to better understand occupancy, movement, and context for more granular and personalized automations and insight. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260916958372/en/ Aqara Announces the Availability of The Spatial Multi-Sensor FP400, Offering Advanced Spatial Intelligence for Smart Homes The Spatial Multi-Sensor FP400 redefines how smart homes perceive and interact with living spaces by combining high-precision spatial sensing with AI-powered environmental understanding. Powered by a next-generation high-precision 60GHz mmWave radar, the FP400 delivers industry-leading multi-person sensing, precise
Cambridge Associates Opens Italian Office and Expands European Leadership16.9.2026 09:00:00 CEST | Press release
Global investment firm Cambridge Associates (CA) today announced the opening of a new office in Milan and the appointment of two senior hires in Europe. The move reflects the firm’s ongoing commitment to providing bespoke services to current and future institutional and family office investors across the region. Raphael Heynold has joined the Client Solutions team as Head of EMEA and APAC and will serve on the firm’s EMEA Operating Committee. Based in London, Raphael is a key member of the Global Client Solutions Leadership team, responsible for driving growth and market expansion and overseeing client engagement efforts across Europe, the Middle East, and Asia Pacific regions. Heynold brings more than 30 years of experience across client strategy, investment banking and investment management, and has worked with many sophisticated families and institutions around the world. Riccardo Pianeti has joined Cambridge Associates to lead the Italian office. He will serve as Head of the Milan
International Expansion Far Outweighs M&A as a Legal and Compliance Execution Burden, CSC Research Finds16.9.2026 08:49:00 CEST | Press release
International expansion far outweighs M&A as a legal and compliance execution burden, cited by 74% of senior cross-border professionals versus 28%54% often redo work because entity or ownership information is incomplete or outdatedHalf say information gaps can add one to two weeks to cross-border work International expansion is creating a far heavier legal and compliance execution burden than M&A itself, with nearly three quarters (74%) of senior cross-border professionals citing market entry or international expansion as a leading burden, compared with just 28% for M&A transactions, according to new research from CSC, the leading provider of global business administration and compliance solutions. The challenge extends well beyond deal execution. Ongoing entity governance and compliance is cited by 71% of respondents, highlighting the operational burden of establishing and maintaining a presence across multiple jurisdictions. CSC’s new report, The Cross-Border Readiness Gap: Navigatin
Okomera Strengthens Its Leadership Team With the Appointment of Marion Ghibaudo as Chief Technology Officer16.9.2026 08:00:00 CEST | Press release
An expert in scaling medical innovations, Marion Ghibaudo joins Okomera as the company advances toward industrial deployment. Okomera, a TechBio company pioneering next-generation cancer care through the development of a proprietary technology platform combining tumor mini-avatars, microfluidics, and AI-powered imaging, today announced the appointment of Marion Ghibaudo as Chief Technology Officer. She will spearhead the company’s technology and innovation strategy and lead the industrial deployment of its integrated hardware, software, and biological platform. Marion Ghibaudo will join Okomera’s Executive Committee and report to CEO Silvère Lucquin. In parallel, Raphaël Tomasi, Okomera’s co-founder and former CTO, transitions to the role of VP Platform, ensuring continuity in the development of the company’s technology platform. Marion’s appointment comes at a key stage in Okomera’s growth as the company advances toward pilot studies, industrial scale-up, and commercialization. Okomer
Galderma’s Restylane® Volyme™ Demonstrates High Effectiveness, Satisfaction and a Robust Safety Profile in Chinese Patients With Temple Hollowing16.9.2026 07:00:00 CEST | Press release
Positive topline results showed that Restylane Volyme (known as Restylane Contour in the U.S.) was highly effective in the correction of moderate-to-severe temple hollowing, with high responder rates maintained through Month 121 Restylane Volyme was well tolerated, with no incidences of granulomas. Patient and investigator satisfaction were also high1 These data support Galderma’s aim to expand the availability of the Restylane portfolio in China – a market undergoing significant expansion, and further strengthen Restylane’s vast clinical evidence base2,3 Galderma (SIX: GALD) today announced positive topline results from a study of Restylane Volyme for the correction of moderate-to-severe temple hollowing in 162 patients in China.1 The study met its primary endpoint, demonstrating the effectiveness and safety of Restylane Volyme versus a no-treatment control, while also achieving high patient and investigator satisfaction.1 These data further reinforce Galderma's ambition to expand its
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