COVID-19

Merck announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for molnupiravir, an investigational oral antiviral (MK-4482, EIDD-2801).

U.S. Food and Drug Administration (FDA) has authorized the emergency use of PAXLOVID (nirmatrelvir tablets and ritonavir tablets) of pfizer for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

GlaxoSmithKline plc and Vir Biotechnology, Inc announced an update to preclinical data on bioRxiv1, a preprint server, demonstrating that sotrovimab, an investigational monoclonal antibody, retains in vitro activity against the full known Omicron spike protein, the new SARS-CoV-2 variant (B.1.1.529). The preclinical data was generated through pseudo-virus testing of the combined known mutations of the Omicron variant, which included the maximum number of changes (37 mutations) identified to date in the spike protein.

Premas Biotech announced that its joint venture Oravax will initiate testing of their oral virus-like particle (VLP) vaccine candidate against Omicron variant of SARS-CoV 2 virus through preclinical, in vitro and challenge studies to assess its efficacy for the new mutant strain. Premas Biotech, Oramed Pharmaceuticals, MyMD Pharmaceuticals, and certain other shareholders formed Oravax Medical to bring an oral COVID-19 vaccine to the market.

SARS-CoV-2 has affected more than 200 million people causing more than 5 million deaths worldwide as per the WHO statistics. The rise in mutant variants of SARS-CoV-2 virus has led to concerns regarding vaccine effectiveness. Delta (B.1.617.2) variant is the predominant strain in India. The vaccination programme in India is driven largely by the Covishield vaccine (ChAdOx1 nCoV-19).

A large analysis of health records from 87 health care centers across the United States found that people taking a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs), particularly fluoxetine, were significantly less likely to die of COVID-19 than a matched control group.

Zydus Cadila has received an order to supply one crore doses of ZyCoV-D, the world’s first Plasmid DNA Vaccine, to the Government of India at Rs. 265 per dose and the needle-free applicator being offered at Rs. 93 per dose, excluding GST. The pricing has been decided in consultation with the Government of India.

Celltrion Group announced that the European Medicine’s Agencys Committee for Medicinal Products for Human Use (CHMP) issued a positive scientific opinion recommending marketing authorisation for regdanvimab (CT-P59), a monoclonal antibody treatment for adults with COVID-19 that do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19. The CHMP positive opinion is a scientific recommendation to the European Commission (EC), which authorises marketing approval in the European Union.

Clotting problems and resulting complications are common in COVID-19 patients. Researchers at the Medical University of Vienna have now shown that a member of the anticoagulant group of drugs not only has a beneficial effect on survival of COVID-19 patients, but also influences the duration of active infection with the SARS-CoV-2 coronavirus. The results were recently published in the journal Cardiovascular Research.