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Gilead’s Antiviral Drug “Remdesivir” receives Emergency Use Authorization (EUA) letter from USFDA for the treatment of COVID-19

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Gilead’s Antiviral Drug “Remdesivir” receives Emergency Use Authorization (EUA) letter from USFDA for the treatment of COVID-19 Gilead’s Antiviral Drug “Remdesivir”  receives Emergency Use Authorization (EUA) letter from USFDA for the treatment of COVID-19. Remdesivir is a nucleoside ribonucleic acid (RNA) polymerase inhibitor. Remdesivir shall be administered through parenteral route (Product is available in the form of preservative-free lyophilized solid that is to be reconstituted with sterile water for injection and diluted into saline prior to intravenous (IV) administration). Remdesivir is a direct acting antiviral drug that inhibits viral RNA synthesis. It is an investigational drug and is not currently approved for any indication. Remdesivir has activity in cell culture and animal models against SARS-CoV, MERS-CoV, and SARS-CoV-2.   In the letter issued to Gilead on 1 st May 2020,
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COVID-19 Flexibility – CDSCO Extends Validity Period of WHO – GMP/COPP

COVID-19 Flexibility – CDSCO Extends Validity Period of WHO – GMP/COPP India’s central Drugs Standard Control Organization (CDSCO) extends the validity of WHO – GMP/COPP in view of Covid-19 outbreak. As per the letter issued by CDSCO on 1st May 2020, the validities of WHO GMP/COPP expiring between March to August 2020 will be extended by six months from the date of expiry of the certificate as per WHO GMP certification guidelines.
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Antiviral Drug “Remdesivir” Promising a “ray of hope” in the fight against COVID-19?

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Antiviral Drug “Remdesivir” Promising a “ray of hope” in the fight against COVID-19? Remdesivir  is an investigational nucleotide analog with broad-spectrum antiviral activity which has inhibitory effects on pathogenic animal and human corona viruses undergoing clinical trials in a number of countries as a potential treatment for COVID-19.Remdesivir is being developed by Gilead Sciences Ireland CU and is given by infusion (drip) into a vein. Ø   Remdesivir is a ‘ viral RNA polymerase inhibitor’ (a medicine that interferes with the production of viral genetic material, preventing the virus from multiplying) Ø   Remdesivir is not yet licensed or approved anywhere globally and has not been demonstrated to be safe or effective for any use. Ø   Remdesivir has demonstrated in vitro and in vivo activity in animal models against the viral pathogens that cause MERS and SARS, which are corona viruses structu
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