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
Galderma Receives U.S. FDA Approval for Restylane® Contour™ for the Correction of Temple Hollowing23.3.2026 07:00:00 CET | Press release
The United States (U.S.) Food and Drug Administration (FDA) has approved Restylane Contour* for the correction of temple hollowing, expanding its use beyond cheek augmentation and midface contour deficiencies to support overall facial balance and harmony1-3 The approval is based on clinical data showing Restylane Contour, part of Galderma’s versatile portfolio of hyaluronic acid injectables, delivers natural-looking results lasting for up to 18 months and high patient satisfaction1,2 This follows the recent U.S. FDA approval for Restylane Lyft™ for the enhancement of the chin profile and the debut of the ‘Wake Up to Restylane’ campaign in the U.S., highlighting Galderma’s commitment to continuing to evolve this versatile portfolio to meet emerging and diverse needs, including the desire for effortless, ‘wake‑up‑ready’ beauty4 Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that the U.S. FDA has approved Restylane Contour for the correction of temple hol
Paving the Way for Real‑Time Earth Observation: Space Compass and SWISSto12 Sign Contract for First Commercial GEO Optical Data Relay Satellite23.3.2026 05:00:00 CET | Press release
Space Compass Corporation (“Space Compass”) and SWISSto12 SA (“SWISSto12”) announced today that they have executed a procurement contract for the first GEO optical data relay satellite. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260320584108/en/ (From Left to Right): Julie Pignon, Legal Counsel, SWISSto12; 倉田 るり子 (Ruriko Kurata), Legal Counsel, Space Compass; 小松 大実 (Hiromi Komatsu), Co-CEO, Space Compass; 田中 良太 (Ryota Tanaka), Engineering Director, Space Compass; Emile de Rijk, CEO, SWISSto12; Fredrik Gustavsson, Chief Financial and Strategy Officer, SWISSto12. This agreement represents a major milestone toward the realization of Space Compass’s optical data relay service. With high-speed, high-capacity optical data relay service, Space Compass aims to transform Earth Observation from just a tracking record into a real-time decision-making tool. For SWISSto12, the contract represents further validation of the company’s a
Andersen Consulting styrker sit cybersikkerhedstilbud gennem samarbejde med Trillium Information Security Systems21.3.2026 02:16:00 CET | Pressemeddelelse
Andersen Consulting udbygger sine kompetencer inden for teknologi og risikostyring gennem en samarbejdsaftale med Trillium Information Security Systems (TISS), et cybersikkerhedsfirma. Med en tilstedeværelse i Canada og Pakistan leverer TISS omfattende cybersikkerhedsløsninger til organisationer inden for finans, telekommunikation og den offentlige sektor. Virksomhedens team tilbyder et bredt udvalg af ydelser, herunder sikkerhedsvurderinger, managed security operations, red team-tjenester, digital efterforskning og hændelsesrespons samt GRC-rådgivning. Med næsten to årtiers erfaring leverer TISS adaptive, efterretningsdrevne forsvarsmekanismer, der hjælper kunder med at forudse og reagere på cybertrusler, der er i konstant udvikling. "Hos TISS arbejder vi på at skabe et mere sikkert digitalt miljø ved at give organisationer mulighed for at operere sikkert og med selvtillid," udtalte Mahir Mohsin Sheikh, administrerende direktør for TISS. "Vores samarbejde med Andersen Consulting giver
Andersen Consulting udvider sin teknologiplatform i Frankrig20.3.2026 17:28:00 CET | Pressemeddelelse
Andersen Consulting udvider sit udbud inden for digital transformation med en samarbejdsaftale med Teolia Consulting, et fransk firma, der specialiserer sig i projekt- og produktstyring, cloud-platformsudvikling, datatransformation samt implementering og brug af Atlassian-pakken. Teolia Consulting blev grundlagt i 2014 og hjælper organisationer med at opnå digital performance, fra agile metoder til løsninger, der reducerer lanceringstiden. Virksomhedens ekspertise består i at levere integrerede strategier, der bringer teknologi og organisatorisk forandring i overensstemmelse. Virksomheden arbejder på tværs af brancher, herunder inden for bank- og finanssektoren, forsikring, mode og detailhandel, og hjælper kunder med at få større robusthed og accelerere deres digitale modenhed. "Hos Teolia Consulting mener vi, at ægte transformation opstår, når teknologi og mennesker udvikler sig sammen," sagde Lucienne Jacquet, der er administrerende partner i Teolia. "Ved at samarbejde med Andersen C
Incyte to Highlight Late-Breaking Hidradenitis Suppurativa Data at the 2026 American Academy of Dermatology (AAD) Annual Meeting20.3.2026 15:00:00 CET | Press release
- New, late-breaking 54-week data for povorcitinib in hidradenitis suppurativa (STOP-HS1 & STOP-HS2) to be highlighted - Featured abstracts for ruxolitinib cream (Opzelura®) and povorcitinib include multiple ePosters in atopic dermatitis, hidradenitis suppurativa and vitiligo Incyte (Nasdaq:INCY) today announced that data from key programs in its Inflammation and Autoimmunity (IAI) franchise will be presented at the 2026 American Academy of Dermatology (AAD) Annual Meeting, to be held March 27 – 31, 2026, in Denver. “At AAD 2026, we are presenting late‑breaking 54-week results from the Phase 3 STOP‑HS program evaluating povorcitinib in hidradenitis suppurativa (HS),” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation and Autoimmunity, Incyte. “These data provide longer term evidence of the safety and efficacy of povorcitinib in HS patients and further strengthen the significant growth potential of our Inflammation and Autoimmunity franchise.” Details on key data presentation
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