Containment Immune Response Licensing Regulation 
Camargo
DECEMBER 13, 2021
Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act. BLA process (CBER).
The Pharma Data
MAY 7, 2021
population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, M.D., regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”. CEO and Co-founder of BioNTech. “We
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XTalks
APRIL 26, 2021
It is the world’s first and only licensed malaria vaccine and also the first licensed for use against a human parasitic disease of any kind. Moreover, a very strong immune response is needed to fend off the disease. Malaria Vaccine Phase II Trial. Two different doses of the adjuvant (MM) were assessed (25 mcg and 50 mcg).
The Pharma Data
OCTOBER 19, 2020
Immune responses following vaccination with PNEUMOVAX 23 (month 13) were comparable in both vaccination groups for the 15 serotypes in V114. Results from both studies are based on opsonophagocytic activity (OPA) responses – a measure of vaccine-induced functional antibodies. among adults 65 years of age or older.
The Pharma Data
OCTOBER 18, 2020
” EB05 is an experimental monoclonal antibody that Edesa believes could regulate the overactive immune response associated with Acute Respiratory Distress Syndrome (ARDS) – the leading cause of death in COVID-19 patients. The company is based in Markham, Ontario, Canada, with a U.S. Sign up for news alerts.
The Pharma Data
SEPTEMBER 8, 2020
Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Moderna”) contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Sanofi, Empowering Life.
The Pharma Data
SEPTEMBER 9, 2020
During preclinical and clinical studies, BNT162b1 and BNT162b2 emerged as strong candidates based on assessments of safety and immune response. The information contained in this release is as of September 7, 2020. Pfizer Disclosure Notice. For more information, please visit www.BioNTech.de. BioNTech Forward-looking Statements.
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