Category: COVID 19
-
Preliminary report of an mRNA Vaccine against SARS-CoV-2
The Phase 1 of the Moderna, SARSCoV2 vaccine results published by NEJM and they are very encouraging for immune response and safety in 45 healthy people, 2 shots, increasing doses. The study is funded by the National Institute of Allergy and Infectious Diseases and others; mRNA-1273 ClinicalTrials.gov number, NCT04283461). This phase 1, dose-escalation, open-label trial including…
-
Remdesivir Liver Toxicity – case study
Remdesivir, the only drug cleared to treat Covid-19, sped the recovery time of patients with the disease, but its benefit appeared much more limited in patients who needed mechanical ventilation as part of their treatment. Although the antiviral agent remdesivir has been shown to shorten recovery time in patients with COVID-19, it has also been…
-
International regulators on phase 3 COVID-19 vaccine trials
Medicines regulatory authorities from around the world have published a report on Thursday highlighting the outcomes of the second workshop on COVID-19 vaccine development that was convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). The report describes the regulatory positions agreed by the meeting participants on two key topics: Data needed…
-
Importance of pharmacovigilance during COVID-19
As the medical and scientific community work tirelessly to find suitable treatments for COVID-19, pharmacovigilance research is essential to understanding the safety and efficacy of treatment alternatives. To collect sufficient information about the efficacy and adverse drug reactions of treatments used against COVID-19, it’s crucial that all adverse events are recorded and reported as quickly…
-
Six months of coronavirus
The scientists are still racing to solve the mysteries behind Coronavirus, from immunity to the role of genetics. In late December 2019, reports emerged of a mysterious pneumonia in Wuhan, China. Six months and more than ten million confirmed cases later, the COVID-19 pandemic has become the worst public-health crisis in a century. More than…
-
ICMRA statement on clinical trials
Recently EMA has endorsed a joint statement on prioritisation of COVID-19 clinical trials published by the International Coalition of Medicines Regulatory Authorities (ICMRA). This statement is intended for all stakeholders, patients, investigators, researchers, academia, regulators, and the pharmaceutical industry. Refer below link to read Statement issued by ICMRA: http://icmra.info/drupal/news/statement_on_clinical_trials Medicines regulators from around the world…
-
Things you need to know about Favipiravir (Glenmark’s approved medicine for mild to moderate COVID-19 in India)
Glenmark’s Fabiflu is the first oral Favipiravir-approved medication for the treatment of COVID-19 and has been launched in few centers. The Drug Controller General of India approved the anti-viral for ‘restricted emergency use’ for treatment of mild to moderate cases, which accounts for a majority of COVID-19 infections. DCGI’s approval was based on Glenmark’s phase…
-
Solidarity trial – update from WHO
Solidarity is an international clinical trial to help find an effective treatment for COVID-19, launched by the World Health Organization and partners. The Solidarity Trial will compare four treatment options against standard of care, to assess their relative effectiveness against COVID-19. By enrolling patients in multiple countries, the Solidarity Trial aims to rapidly discover whether any of the drugs…
-
Researchers identify four possible treatments for COVID-19
While COVID-19 has infected millions of people worldwide and killed hundreds of thousands, there is currently no vaccine. In response, researchers have been evaluating the effectiveness of various antiviral drugs as possible COVID-19 treatments. Researchers at the University of Missouri, University of Nebraska Medical Centre, Emory University School of Medicine and Karolinska Institute have found…
-
FDA approves emergency use of remdesivir to treat coronavirus
U.S. regulators on Friday allowed emergency use of an experimental drug that appears to help some coronavirus patients recover faster. It is the first drug shown to help fight COVID-19, which has killed more than 230,000 people worldwide. The FDA said in a statement that Gilead Science’s intravenous drug remdesivir would be specifically indicated for…