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Novavax COVID-19 Vaccine Granted Fast Track Designation by U.S. FDA

The Pharma Data

Novavax expects to begin its pivotal Phase 3 clinical trial in the United States and Mexico by the end of November. Data from the event-driven trial could support global authorization and approval, including in the U.S. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. and globally.”.

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Novavax Announces Agreement with Government of New Zealand for 10.7 Million Doses of COVID-19 VaccineAdvance purchase agreement signed for NVX-CoV2373, Novavax’ adjuvanted protein vaccine candidate

The Pharma Data

NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein adjuvanted with Novavax’ patented saponin-based Matrix-M to enhance the immune response and stimulate high levels of neutralizing antibodies. and Australia.

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Novavax Announces COVID-19 Vaccine Clinical Development Progress

The Pharma Data

Two of the three planned late-stage efficacy trials for NVX-CoV2373 sponsored by Novavax are fully enrolled, and more than 20,000 participants have been dosed to-date. In alignment with Novavax’ commitment to transparency, Phase 3 clinical trial protocols are posted to the company’s website at Novavax.com/resources upon finalization.

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Amgen To Acquire Privately Held Teneobio For $900 Million In Cash With Future Contingent Milestone Payments

The Pharma Data

Acquisition Complements Amgen’s Antibody Research Capabilities Across Therapeutic Areas Acquisition Includes a Portfolio of Early-Stage Oncology Assets, Including a Phase 1 Bispecific Antibody for Patients With Advanced Prostate Cancer. billion in cash. Reese, M.D., executive vice president of Research and Development at Amgen.

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Clinical Catch-Up: January 4-8 | BioSpace

The Pharma Data

The new year began with a fairly low level of clinical trial news. Arcturus Therapeutics got the FDA go-ahead for its Phase II trial of its COVID-19 vaccine candidate ARCT-021. The trial will enroll 600 participants, with 450 receiving ARCT-021 and 150 receiving placebo. CERC-002 is a human anti-LIGHT monoclonal antibody.

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Company Spotlight: Cue Biopharma Innovates in the Immunotherapy Space with its Immuno-STAT Platform

XTalks

With several biologics in the pipeline, including one in early stage clinical trials for head and neck cancer, the company is positioned to engineer highly specific biologics against immune targets in the body. Monoclonal antibodies : these are antibodies that are designed to bind to specific targets on cells.

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Biopharma Leaders Unite To Stand With Science

The Pharma Data

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. Sanofi, Empowering Life.