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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 

Agnes Shanley is senior editor of Pharmaceutical Technology.

Charles River Associates analysts see risk-sharing as the key to improving vaccine availability and access.



New Risk-Sharing Models Are Needed for Future Vaccine Supply Agreements 

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

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

The Trump administration unveiled a new drug price control policy, drawing opposition from pharma manufacturers and pharmacy benefit managers.

Trump’s Revenge on Pharma

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

Researchers concluded that the nasal spray should catch and coat the virus inside the nose, preventing it from spreading throughout the body, and it is then removed by nose-blowing or swallowing.

The University of Birmingham Formulates Nasal Spray to Protect Against COVID-19

A second global Phase III clinical trial investigating the safety and efficacy of a two-dose regimen of JNJ-78436735 has been initiated by Johnson & Johnson.

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