2021 Drug Development FDA Approval Immune Response 
The Pharma Data
JANUARY 31, 2021
Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinical development.”
The Pharma Data
DECEMBER 3, 2020
Strong Th1 cell-mediated immune responses were also observed for the vaccine candidates with either adjuvant. Clover intends to initiate a separate pivotal clinical trial of the S-Trimer vaccine candidate in combination with Dynavax’s advanced CpG 1018 adjuvant plus alum in the first half of 2021. About Trimer-Tag © Technology.
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Agency IQ
DECEMBER 1, 2023
FDA’s guidance on developing products to prevent or treat Covid-19 Of the five guidance documents that received an extension, one addresses the development of drugs and biological products for Covid-19. About one year after its initial publication, FDA updated the guidance in February 2021.
NIH Director's Blog: Drug Development
FEBRUARY 16, 2021
They are called immune modulators because they help to minimize the effects of an overactive immune response in some COVID-19 patients. This response, called a “cytokine storm,” can lead to acute respiratory distress syndrome, multiple organ failure, and other life-threatening complications.
The Pharma Data
DECEMBER 29, 2020
The analysis was prospectively designed to focus on patients who had not yet mounted their own immune response to SARS-CoV-2 (i.e., The company expects to complete the manufacture of these doses on schedule in January 2021 and is in discussions with the U.S. and Roche will develop, manufacture and distribute it outside the U.S.
Drug Discovery World
MAY 11, 2023
Another dangerous consequence can occur when the therapeutic or vaccine introduces proteins that can activate an uncontrolled immune response. In the case of therapeutics, the aim is usually to avoid patients’ immune responses. “Clinical features of vaccine-induced immune thrombocytopenia and thrombosis.”
The Pharma Data
SEPTEMBER 8, 2021
today announced that data reinforcing the potential of immunotherapies to impact clinical outcomes for patients will be featured at the European Society for Medical Oncology (ESMO) 2021 Virtual Congress from September 16-21. executive vice president, chief medical officer, Global Drug Development, Bristol Myers Squibb.
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