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
Bureau Veritas Confirms LEAP | 28 Ambition, Upgrades Total Revenue Growth to Double-Digit in 2027 – 20281 and Targets EUR1 Billion Revenue in AI-Driven Markets and Services by 203022.9.2026 07:30:00 CEST | Press release
Bureau Veritas (BOURSE:BVI): CAPITAL MARKETS DAY 2026 Today, Bureau Veritas hosts its Capital Markets Day. The Company will present an update on the progress of its LEAP | 28 strategy, building on three years of successful execution. › 2024-2026 achievements:Proven track record: mid-to-high single-digit organic revenue growth (7-8%) delivered across 2023–2026e2, with 115 basis points of adjusted operating margin improvement3; Portfolio transformation on track: c. 21.0% of the portfolio rotated since LEAP | 28 launch, with EUR1.2 billion of revenue acquired, sold or to be exited through 24 acquisitions, 4 divestments and 1 exit; New operating model: the active portfolio management delivered allowed the Company to create a new operating model that simplifies its growth algorithm. Combined with a simplified organization with four divisions and ten Product Lines, it sharpens Bureau Veritas’ position as a focused multi-specialist Company; Driving growth and profitability: through Portfolio
OPM Biosciences Launches Integrated Cell Culture Media-to-Manufacturing Platform for Biosimilar Development22.9.2026 07:00:00 CEST | Press release
New portfolio combines high-performance cell culture media, molecule-specific CQA optimization, and integrated CDMO capabilities to help biosimilar developers accelerate the path to analytical similarity and improve process economics. OPM Biosciences, a cell culture media and bioprocess solutions company, today announced two new offerings that extend its OPM-CHO™ platform into biosimilar development and manufacturing: the Biosimilar Media Optimization Service and the Sureness™ Biosimilar Platform. Cell culture media can significantly influence cell growth, productivity, and critical quality attributes (CQAs), making media strategy an important component of biosimilar process development. OPM-CHO, the company’s portfolio of chemically defined cell culture media for CHO-based biomanufacturing, has supported more than 390 molecules in clinical and commercial stages worldwide, including biosimilars. Across 35 side-by-side evaluations, OPM-CHO media delivered an average titer improvement of
H2SITE Secures €3.4 Million (NOK 39.1 million) in Enova Funding to Scale Onboard Ammonia-To-Power for Commercial Maritime Applications22.9.2026 06:00:00 CEST | Press release
The 700 kW system builds on H2SITE’s previous maritime deployments and is designed as a modular, replicable solution for auxiliary power onboard vessels H2SITE has secured €3.4 million (NOK 39.1 million) in funding from Enova for HydraNord Power, a project that will develop and validate a commercial-scale onboard ammonia-to-power system for the maritime sector. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260921324898/en/ Enova is one of the Norwegian government's primary instruments for accelerating the country's climate and energy transition. Its primary responsibility is to manage the Climate and Energy Fund on behalf of the Norwegian government. For H2SITE, Enova’s support is a major milestone in the commercialisation of its onboard ammonia cracking technology, enabling the company to scale from proven maritime demonstrations to replicable commercial solutions for the global shipping industry. Led by H2SITE, HydraNord
EcoOnline Recognised as a Leader in Verdantix Green Quadrant: EHS Software 2026 for Third Time21.9.2026 18:43:00 CEST | Press release
EcoOnline achieved highest score for Safety Management and ranked among the top three vendors for Chemicals Management, Training and Contractor Safety with Lone Worker Protection a key differentiator. EcoOnline, the global provider of software that transforms how organisations protect people and the planet, has been recognised for the third consecutive time as a Leader in the independent Verdantix Green Quadrant: EHS Software 2026 report, with market-leading strength in Safety Management. The assessment evaluated leading vendors of environmental, health and safety software vendors across a range of capabilities and customer buying signals. Verdantix recognised EcoOnline’s strength in the areas organisations rely on to protect workers every day: Safety Management, Chemicals Management, AI-enabled Training and Contractor Safety. It reflects the changing needs of EHS buyers, who are increasingly looking for integrated platforms that connect everyday safety with broader operational risk an
rhode Announces the Return of Limited Edition Favorites and New Exclusives at Sephora Across Europe and the U.K.21.9.2026 15:00:00 CEST | Press release
rhode, the beauty brand founded by Hailey Rhode Bieber and part of e.l.f. Beauty (NYSE: ELF), has announced that two community-favorite Peptide Lip Tints and a new Sephora-exclusive bag will launch at Sephora across Europe and the U.K. to celebrate the brand’s launch into Sephora in Europe on September 30, 2026. These items will join the brand’s assortment of high-performance skincare and hybrid makeup. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260921199856/en/ rhode announces the return of limited edition favorites and new exclusives at Sephora across Europe and the U.K. To mark the occasion with Sephora across Europe and the U.K., rhode is offering early access to purchase fan-favorite, previously limited edition Peptide Lip Tint in Pretzel at Sephora in Europe and the U.K. on the brand’s launch date September 30, before the product joins rhode’s permanent assortment globally on rhodeskin.com on October 1 and at all r
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