2 December 2020
Pfizer and BioNTech have applied for Conditional Marketing Authorisation (CMA) of its mRNA vaccine candidate, BNT162b2, to fight the Covid-19 disease to the European Medicines Agency (EMA). The submission completes the rolling review process and all clinical data submitted by Pfizer and BioNTech. If the EMA approves the vaccine, it will be granted a CMA for use in Europe by the end of 2020.
Dr Reddy’s and the Russian Direct Investment Fund announced today that they have begun adaptive Phase II/III clinical trials of the Sputnik V vaccine candidate in India. The trials began after receiving a clearance from the Central Drugs Laboratory, Kasauli, in India. The multi-centre randomised controlled study will investigate its safety and immunogenicity.
Rhizen Pharmaceuticals announced that it has sought Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) to test its oral DHODH inhibitor against Covid-19. The company announced that it will evaluate single doses of RP7214 among healthy individuals in its initial study, which is set to begin in early December 2020.
Celularity announced that the independent Data Monitoring Committee (DMC) has reviewed the its Phase I/II CYNK-001-COVID-19 study conducted among Covid-19 positive adults. The DMC confirmed the absence of toxicities and worsening inflammatory biomarkers, therefore allowing the trial to move ahead. Enrolment has begun for the multi-centre clinical study at Arizona, California, Arkansas, Washington, and New Jersey.