ARC Regulatory
About ARC Regulatory
Our team of knowledgeable advisors is committed to ensuring that our clients are reasonably satisfied at every point of the life cycle of a medical device and that they are entirely up to speed with the continuously changing regulatory standards.
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Novavax, Inc.
A late-stage biotechnology business called Novavax, Inc. (Nasdaq: NVAX) works to advance global health by discovering, creating, and commercializing novel vaccines to fend off deadly infectious illnesses. Clinical studies are being conducted for NVX-CoV2373, a vaccine candidate by Novavax against COVID-19's causative virus, SARS-CoV-2. In the Phase 1 section of the Phase 1/2 clinical study, NVXCoV2373 was usually well tolerated and produced significant antibody responses that were quantitatively greater than those found in human convalescent sera. In its critical Phase 3 clinical study in older individuals, NanoFluTM, its quadrivalent influenza nanoparticle vaccine, achieved all major goals. Both vaccination candidates use Novavax's patented Matrix-MTM adjuvant, which is based on saponins and stimulates the production of large quantities of neutralizing antibodies. A renowned producer of recombinant vaccines, Novavax's
4D Pharma
The FDA defines Live Biotherapeutics as biological products that contain a live organism, such as a bacterium, that are useful in the prevention, treatment, or cure of a disease. 4D Pharma, founded in February 2014, is a global pioneer in the development of Live Biotherapeutics.
Vaccitech
Vaccitech is a firm that is working on creating products for the treatment and prevention of cancer and infectious diseases. Chimpanzee Adenovirus (prime) and MVA (boost), two components of the company's patented technology platform, are incredibly effective at stimulating, sustaining, and maintaining CD8+ and CD4+ T cells as well as antibodies. The Jenner Institute at the University of Oxford, one of the most esteemed vaccine research institutions in the world, has granted Vaccitech a licence to use its prime-boost platform. Vaccitech is about to launch its HPV and NSCLC medicines in the clinic and currently has a Phase 2a clinical programme for prostate cancer. In addition, the business is working on MERS coronavirus and Herpes zoster vaccines with international partners, and it has granted University of Oxford-AstraZeneca an outlicense for the ChAdOx COVID-19 vaccine.