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
Ant International and Bank Partners Achieve Real-Time Cross-Bank Liquidity Management through Tokenised Deposits via CeBM under HKMA’s EnsembleTX3.11.2026 05:10:00 CET | Press release
Transfers were among the first batch of live transactions completed under EnsembleTX, unlocking 24/7 liquidity access and near-instant settlement Following the Hong Kong Monetary Authority’s (HKMA) announcement on interbank settlement of tokenised deposit transactions under EnsembleTX, Ant International announced that it has achieved real-time cross-bank liquidity management with its key banking partners as part of its active participation in EnsembleTX. In close collaboration with Bank of China (Hong Kong) (“BOCHK”, SEHK: 2388), China Construction Bank (Asia) (“CCB (Asia)”) and HSBC (SEHK: 5), Ant International successfully completed a series of live HKD interbank transactions between September and October 2026: BOCHK interbank transactions with CCB (Asia) CCB (Asia) interbank transactions HSBC interbank transactions Executed using tokenised deposit settled through the HKMA’s Central Bank Money (CeBM), the transfers were initiated via Ant International’s proprietary blockchain-based w
SuperElastic* Material Unveiled by Angelalign2.11.2026 18:46:00 CET | Press release
New, Improved Clear Aligner Material Gives Orthodontists More Control Angelalign Technology Inc. (6699.HK) (“Angel”)http://www.angelaligner.com, a global clear aligner leader, today unveiled SuperElastic (MC-SE*), a new propietary aligner material that is a significant breakthrough in performance over its current material. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261102654659/en/ Specialists in orthodontics have long asked for new aligner materials that enable better treatment for complex cases: biologically safe force levels, a large elastic working range, and strength and toughness. MC-SE* provides all of them. “Angel is commited to innovation and never settling for 'good enough'. MC-SE* is the result of seven years of materials research, testing and manufacturing optimization. The new material aims to create a new generation of aligner material that allows orthodonists to differentiate their treatment from other tre
Galderma Announces Proposed Board Appointments and Chief Financial Officer Transition2.11.2026 18:00:00 CET | Press release
The Company will hold an Extraordinary General Meeting on December 3, 2026 to further reinforce its Board of DirectorsAd hoc announcement pursuant to Art. 53 LR Galderma Group AG (SIX:GALD), the pure-play dermatology category leader, today announced proposed changes to its Board of Directors, aimed at further strengthening its governance and supporting its long-term growth. The company also announced that Luigi La Corte, Chief Financial Officer (CFO), has decided to leave Galderma to pursue a significant new opportunity. Luigi La Corte will continue to fulfil his responsibilities as CFO during the transition period, supporting business continuity and a smooth handover. The company will communicate further details regarding succession arrangements and the transition timeline in due course. The Board of Directors is proposing the election of Rosalind Brewer and Petra Rumpf as new Board members. Both candidates bring extensive leadership and governance experience, alongside expertise span
Donaldson Introduces Alpha-Pore™ Technology Platform for Extended Sterile Filtration Performance2.11.2026 15:35:00 CET | Press release
Donaldson Company, Inc. (NYSE: DCI), a leading worldwide manufacturer of innovative filtration products and solutions, today announced Alpha‑Pore™ technology, a next generation sterile filtration platform engineered to extend filter service life while maintaining critical process performance. Built for critical applications, Alpha‑Pore technology enables longer filter run time compared with competitive single- and dual-layer polyethersulfone (PES) membrane filters, while maintaining flow characteristics, sterility assurance, and process integrity.* The platform is designed to help manufacturers improve operational efficiency through fewer changeouts and more consistent performance over time. Engineered for Extended Performance Sterile filtration processes often require balancing run time with key performance parameters such as flow, differential pressure, and contaminant retention. Alpha‑Pore technology is designed to achieve all three. By optimizing pore structure and filter architect
SBC Medical Forms Capital and Business Alliance with AtomicSoftware, Provider of the medicalforce Clinic Management Platform Used by 800+ Clinics in Japan2.11.2026 15:00:00 CET | Press release
Companies to co-develop AI features, starting with physician documentation support, to enhance medicalforce and SBC Medical’s in-house systems and drive per-clinic productivity and profitability SBC Medical Group Holdings Incorporated (Nasdaq: SBC) (“The Company” or “SBC Medical”), a Medical Services Organization (MSO) providing management support across a wide range of healthcare fields, today announced that it entered into a capital and business alliance agreement on October 26, 2026, with AtomicSoftware Inc. (“AtomicSoftware”), the Tokyo-based provider of medicalforce, an all-in-one software-as-a-service (SaaS) platform for clinics. In connection with the alliance, SBC Medical has invested ¥600 million (approximately US$3.8 million) in AtomicSoftware’s Series C funding round. The two companies will co-develop AI features, beginning with a feature that supports physicians in preparing medical records. Key HighlightsProven platform: medicalforce is used by more than 800 clinics*1 in J
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