Quality Systems

Articles

FDA granted fast track designation for AB201, a small recombinant protein that is a potent, selective inhibitor of tissue factor, for the potential treatment of COVID-19. 

FDA Grants Fast Track Designation to ARCA biopharma’s Potential COVID-19 Treatment

The EC’s approval was based on positive results from a Phase III clinical trial that demonstrated a statistically significant and clinically meaningful improvement in patients compared to chemotherapy.

EC Approves Bristol Myers Squibb’s Opdivo in Second-Line Treatment of Esophageal Cancer

The EC’s approval comes after positive results from seven Phase II and III randomized, active-controlled, multi-center studies.

EC Approves Sanofi’s Meningococcal Meningitis Vaccine 

EMA has requested the full data from the Solidarity trial in order to evaluate the marketing authorization of Veklury (remdesivir) in the European Union.

EMA Requests Full Solidarity Trial Data to Evaluate Remdesivir Authorization

When administered together in clinical trials, casirivimab and imdevimab were shown to lessen COVID-19 hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo. 

FDA Issues EUA for COVID-19 Monoclonal Antibody Treatment

Following an EUA application from Pfizer and NioNTech, FDA outlines the process for committee and agency review. 

FDA Schedules COVID-19 Vaccine Review for Dec. 10. 2020

Stephen Hahn promises disclosure of supporting scientific data used to issue EUAs.


FDA Commits to Transparency in EUA Reviews

AstraZeneca has received approval for Calquence (acalabrutinib) to be used as a treatment of chronic lymphocytic leukemia (CLL) in adults within the European Union (EU).

Calquence Gains EU Approval for Treatment of Chronic Lymphocytic Leukemia

The vaccine will enter into a Phase III clinical trial in the United States and Mexico by the end of November, which could potentially support global authorization and approval of the vaccine.

FDA Grants Fast Track Designation to Novavax’s COVID-19 Vaccine Candidate

Experts examine the role technology can play in quality programs at the 2020 Bio/Pharma Virtual Congress. 

Regulatory Authority Actions