COVID-19

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.

Premas Biotech, a developer of novel biotherapeutic and vaccine candidates announced that Oravax Medical Inc., a US based company that Premas Biotech is a partner in, has received clearance from the South African Health Products Regulatory Authority to commence patient enrollment in a first in human, Phase 1 clinical trial, for its oral COVID-19 vaccine; and preparations to begin the trials are now underway.

Pfizer Inc and BioNTech SE announced that the U.S. Food and Drug Administration has authorized for emergency use the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age (also referred to as 5 to <12 years). For this age group, the vaccine is to be administered in a two-dose regimen of 10-µg doses given 21 days apart. The 10-µg dose level was carefully selected based on safety, tolerability and immunogenicity data. This is the first COVID-19 vaccine authorized in the U.S. for individuals 5 through 11 years of age.

Antibodies in the airways quickly wane after SARS-CoV-2 infection, but vaccination results in a strong increase in antibody levels, especially after two doses, according to a new study from Karolinska Institutet in Sweden published in the journal JCI Insight. The results suggest that having a second dose of vaccine also after recovering from COVID-19 may be important for protecting against re-infection and to prevent transmission.

LumiraDx a next-generation point of care diagnostics testing company announced it has received emergency use approval by India’s Central Drugs Standard Control Organisation for its SARS-CoV-2 Antigen test for use in India. The test detects antigen nucleocapsid protein from a nasal swab with results in under 12 minutes from sample application.

 After helping several Indian companies in the development of vaccines for COVID-19 including clinical trials, the Department of Biotechnology (DBT)’s Translational Health Science and Technology Institute (THSTI) has entered into a research collaboration with Nanogen Pharmaceutical Biotechnology JSC, a Vietnamese pharmaceutical company which is in the process of developing a vaccine for the disease.

The research team assembled an unprecedented dataset on mortality from 29 countries, spanning most of Europe, the US and Chile – countries for which official death registrations for 2020 had been published. They found that 27 of the 29 countries saw reductions in life expectancy in 2020, and at a scale which wiped out years of progress on mortality, according to the paper published today in the International Journal of Epidemiology.

Glenmark Pharmaceuticals, a research-led, global integrated pharmaceutical company, today announced the successful completion of its Post Marketing Surveillance (PMS) study on Favipiravir (FabiFlu®) in India. The PMS study commenced in July 2020 to evaluate the safety and efficacy of Favipiravir in mild to moderate COVID-19 patients. A total of 1083 patients were enrolled in the prospective, open label, multicentre, single arm study.