Hyundai Bioscience has announced plans to submit a fast-track processing request for an oral antiviral drug candidate to treat monkeypox, CP-COV03, to US FDA. Niclosamide is the active ingredient of CP-COV03, a cell-directed drug as against other virus-directed drugs. CP-COV03 was developed by the company to treat Covid-19. The latest decision comes after Hyundai Bioscience learned that CP-COV03 could receive a fast-track processing under the Animal Rule from the FDA. The Animal Rule is a kind of fast-track adopted by the regulatory agency for new therapies for infections such as smallpox or monkeypox as an alternative to standard clinical trials.

The University of Minnesota (U of M) is set to establish a centre for developing antiviral drugs for future viral pandemics, including the SARS-CoV-2 virus, after it received the US National Institute of Allergy and Infectious Diseases (NIAID) award of $66m. The Midwest Antiviral Drug Discovery (AViDD) Center is part of a network of nine national centres set up by NIAID to tackle Covid-19-caused public health emergency. The Midwest AViDD Center merges collaborative researchers from the university and 16 other institutions in the US. The initial duration of the project is three years and is expected to be expanded to five years with further funding of over $20m each year.

AbbVie has filed a new drug application (NDA) with the US FDA for ABBV-951 (foscarbidopa/foslevodopa) to treat motor fluctuations in individuals with advanced Parkinson’s disease (PD). A solution of carbidopa and levodopa (CD/LD) prodrugs, ABBV-951 is intended for continuous subcutaneous administration. As against oral CD/LD, ABBV-951 provides the potential to enhance motor fluctuations in advanced PD patients. The latest submission is based on findings from a head-to-head, controlled and randomised Phase III M15-736 clinical trial that analysed the safety, efficacy and tolerability of ABBV-951 versus oral immediate-release CD/LD in advanced PD patients. It enrolled nearly 130 advanced PD adult patients across 80 sites in the US and Australia.

Cocrystal Pharma has expanded a Non-Clinical Evaluation Agreement (NCEA) with the National Institutes of Health (NIH) unit NIAID to carry out exploratory preclinical studies of the former’s 3CL protease inhibitors to treat Covid-19.  Under the NIAID partnership, Cocrystal offered its process chemistry knowledge for its oral 3CL protease inhibitors. Cocrystal is developing Covid-19 drug candidates that act on proteins linked to viral replication. Regardless of the different strains that may exist or evolve, these enzymes are needed for viral replication and are highly conserved across all strains. The antiviral compounds are designed to be effective against key strains of the virus by acting on these highly conserved regions of the replication enzymes.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the US FDA has voted 21 to 0 recommending the grant of Emergency Use Authorization (EUA) for Novavax’s Covid-19 vaccine, NVX-CoV2373, for people of the age 18 years and above. If granted, NVX-CoV2373 would become the first protein-based Covid-19 vaccine to be offered in the US.

China’s Sinovac Biotech has received prequalification from the World Health Organization (WHO) for its Poliomyelitis Vaccine (Vero Cell, Inactivated Sabin strains) (sIPV). The vaccine will be made available for procurement by the United Nations (UN) agencies. The vaccine is intended for active immunisation against polioviruses Type 1, 2, and 3 in infants.