Key Developments

In April 2023, Shionogi & Co., Ltd., a pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track designation for its investigational COVID-19 oral antiviral ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.: S-217622, hereafter “ensitrelvir”). FDA Fast Track designation is designed to facilitate the development and expedite the review of potential new therapies that treat serious conditions and fulfill an unmet medical need
In May 2022, The National Institutes of Health (NIH) announced that PostEra, a biotechnology company specializing in machine learning for preclinical drug discovery, had been awarded USD 68 million as part of the agency’s efforts to develop antiviral drugs to prevent the COVID-19 pandemic.
In December 2021, Cipla, a pharmaceutical company, announced that it had been granted Emergency Use Authorisation (EUA) permission by the Drug Controller General of India (DCGI) for the launch of Molnupiravir in the country. Cipla plans to launch Molnupiravir under the brand name Cipmolnu.
In November 2021, Pfizer Inc., a pharmaceutical company, and the Medicines Patent Pool (MPP), a United Nations-backed public health organization working to increase access to life-saving medicines for low- and middle-income countries, announced license agreement for Pfizer’s COVID-19 oral antiviral treatment candidate PF-07321332, which is administered in combination with low dose ritonavir (PF-07321332; ritonavir). The agreement will enable MPP to facilitate additional production and distribution of the investigational antiviral, pending regulatory authorization or approval, by granting sub-licenses to qualified generic medicine manufacturers, with the goal of facilitating greater access to the global population.