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
Union of Kansai Governments: Kansai Deep Tech Ecosystem Gains Global Visibility31.3.2026 02:00:00 CEST | Press release
Platform Update Reflects 20-Place Rise in GSER Ranking The Union of Kansai Governments has refreshed the Kansai Startup Ecosystem portal, strengthening the region’s global communication platform for startups and deep tech. At the same time, the “DeepTech Frontier Kansai” website has also been updated, further enhancing international visibility for Kansai’s rapidly growing deep tech ecosystem. Kansai’s startup ecosystem has demonstrated steady growth in recent years. The ecosystem’s total value expanded from USD 2.68 billion in 2023 to USD 3.23 billion in 2025. In addition, Kansai rose 20 places in the Global Startup Ecosystem Ranking (GSER) published by Startup Genome, climbing from 99th in 2023 to 79th in 2025, and early-stage funding reached USD 124 million. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260330459051/en/ Kansai’s Strength in Deep Tech Kansai represents a rare ecosystem where fundamental research and indust
Merz Aesthetics® Announces EU Approval of Two New Indications for Their Hyaluronic Acid Filler BELOTERO® Balance30.3.2026 22:49:00 CEST | Press release
Merz Aesthetics®, the world’s largest dedicated medical aesthetics business, is pleased to announce that BELOTERO® Balance has received EU approval for two additional indications: the treatment of infraorbital hollow (including the tear trough) and horizontal forehead lines1*. “With these new approvals, BELOTERO® Balance further strengthens its position as a versatile hyaluronic acid dermal filler, with a wide range of approved facial indications1 designed to integrate seamlessly within the skin and deliver predictable, harmonious aesthetic outcomes,” said Dr. Kerstin Olsson, Head of Medical Affairs EMEA. The approval of these two new indications is supported by compelling clinical evidence: In a clinical investigation on infraorbital hollow, 98.9% of subjects demonstrated visible improvement at Week 8, with long-lasting results sustained up to 72 weeks, and no treatment related serious adverse events reported.2 Similarly, in a postmarket investigation on horizontal forehead lines, 82.
Klarna Payments Now Available at B-Parts, Europe's Largest Automotive Parts Website30.3.2026 21:51:00 CEST | Press release
B-Parts is now offering its customers a more personalised and flexible shopping experience, with interest-free payments via "Pay in 3", amongst other Klarna features. Klarna, the global digital bank and flexible payments provider, is joining forces with B-Parts, a leading online retailer of used and original car parts, to offer consumers greater flexibility, convenience, choice and control at the point of payments, with no interest or hidden fees. Through Klarna’s interest-free installment payments, B-Parts customers will benefit from greater flexibility and control over their finances. Klarna also ensures a secure shopping experience thanks to its buyer protection scheme, as well as a range of features such as cashback and deals. "We continue to grow locally, with an increasing number of brands across different sectors recognising the enormous advantage of offering their customers more payment options, those that make for a more convenient and seamless checkout experience," explains I
Office of His Highness Sheikh Hamdan Bin Ahmed Al Maktoum Holdings & Gatbits IT Infrastructure Announce Launch of GTBS Digital Ecosystem; Mainnet Set for April 202630.3.2026 20:30:00 CEST | Press release
The Office of His Highness Sheikh Hamdan Bin Ahmed Al Maktoum Holdings, in collaboration with Gatbits IT Infrastructure, has officially announced the launch of the GTBS Digital Ecosystem, marking a significant step forward in the global Web3 space. The announcement follows the successful launch of the native GTBS Coin on December 25, with the ecosystem’s mainnet scheduled to go live in April 2026. GTBS represents a full-stack Web3 ecosystem integrating blockchain, artificial intelligence, decentralized finance (DeFi), entertainment, gaming, media, and cloud infrastructure into a unified platform. Built on the philosophy of “All Commitment On Time,” the ecosystem focuses on delivering reliability, scalability, and real-world utility. Designed as a comprehensive digital infrastructure, GTBS goes beyond standalone crypto platforms by offering an integrated environment for users, developers, creators, and enterprises. Its proprietary Layer-1 blockchain powers seamless interaction across se
Yubico Appoints Poupak Modirassari Enbom as Chief Marketing Officer to Accelerate Global Momentum and Drive Market Leadership30.3.2026 15:00:00 CEST | Press release
Yubico (NASDAQ STOCKHOLM: YUBICO), the creator of the most secure passkeys and a leading provider of hardware authentication security keys, today announced the appointment of Poupak Enbom as Chief Marketing Officer (CMO). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260330278027/en/ Enbom joins Yubico at a pivotal moment as organizations worldwide accelerate the shift to phishing-resistant authentication and modern identity security in the age of AI. “We’re excited to welcome Poupak to Yubico,” said Jerrod Chong, acting chief executive officer, Yubico. “As the threat landscape evolves with AI-driven attacks and increasing automation, organizations are rethinking how they secure digital identities of both humans and AI agents at scale. She brings a unique combination of technical depth, global leadership, and customer-first mindset that will help us continue to expand our impact and support our customers and partners around
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