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Dr. Reddy’s Laboratories gets DCGI nod for phase 3 trial of Sputnik V vaccine

Dr. Reddy’s Laboratories gets DCGI nod for phase 3 trial of Sputnik V vaccine

Dr. Reddy’s Laboratories has secured the go-ahead from the Drugs Control General of India (DCGI) to begin phase 3 clinical trial for the Russian Covid-19 vaccine Sputnik V in India. The Indian pharma company plans to hold the phase 3 study on 1500 volunteers as part of the randomized, double-blind, parallel-group, placebo-controlled study. G V […]

Dr. Reddy’s reports success for Russian Covid-19 vaccine Sputnik V

Indian pharma company Dr. Reddy’s Laboratories announced that Sputnik V, a registered Covid-19 vaccine in Russia, has succeeded in a phase 2 trial in India by meeting the primary endpoint of safety. An independent data and safety monitoring board (DSMB) has recommended the Sputnik V Covid-19 vaccine to be advanced to a phase 3 trial […]

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India approves Serum Institute’s Covishield and Bharat Biotech’s Covaxin vaccines

The Drugs Controller General of India (DCGI) has granted emergency approvals to Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin vaccines for the prevention of Covid-19. COVISHIELD has been developed at the Serum Institute of India’s laboratory in Pune with a master seed from Oxford University and pharma giant AstraZeneca. According to DCGI VG […]

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Swissmedic authorizes use of BNT162b2 Covid-19 vaccine from Pfizer, BioNTech

Swissmedic, the Swiss Agency for Therapeutic Products, has authorized the use of the BNT162b2 Covid-19 vaccine from US pharma giant Pfizer and German biotech company BioNTech. The Swiss pharma regulator said that as per the data it has assessed, the level of protection afforded seven days following the second dose of the mRNA vaccine is […]

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Lilly to launch pragmatic study of Covid-19 drug candidate bamlanivimab in New Mexico

Eli Lilly and Company (Lilly) has revealed plans to launch a new pragmatic study of bamlanivimab (LY-CoV555) in high-risk patients with Covid-19, in partnership with major local institutions in New Mexico. The US pharma giant said that carrying out the study in New Mexico will help in the collection of data on the effectiveness and […]

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US FDA authorizes Moderna Covid-19 vaccine mRNA-1273

Moderna Covid-19 vaccine : The US Food and Drug Administration (FDA) has given emergency use authorization (EUA) for mRNA-1273, the messenger RNA (mRNA) Covid-19 vaccine candidate of Moderna. The FDA authorization is for the use of mRNA-1273 in individuals aged 18 years and more for the prevention of Covid-19 caused by severe acute respiratory syndrome […]

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Pfizer and BioNTech secure FDA EUA for BNT162b2 Covid-19 vaccine

BNT162b2 FDA EUA : Pfizer and BioNTech have been granted emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for BNT162b2, their Covid-19 mRNA vaccine. BNT162b2 has been authorized by the FDA for its use in the prevention of Covid-19 in individuals aged 16 years or more. Pfizer and BioNTech will look […]

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Pfizer, BioNTech get Canadian approval for BNT162b2 Covid-19 vaccine

US pharma giant Pfizer and German biotech company BioNTech have bagged Health Canada approval for their BNT162b2 Covid-19 vaccine. The BNT162b2 vaccine has been authorized to be used in Canada under the regulator’s Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to Covid-19. Canada has now joined the UK […]

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Bamlanivimab Covid-19 drug candidate : Lilly, UnitedHealth Group join forces for pragmatic study

Eli Lilly and Company (Lilly) has entered into a partnership with managed care company UnitedHealth Group to carry out a pragmatic study of bamlanivimab (LY-CoV555) in high-risk, Covid-19 infected individuals. Recently, bamlanivimab was granted emergency use authorization (EUA) from the US Food and Drug Administration for the treatment of Covid-19 patients having mild to moderate […]

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PRESECO clinical trial for Avigan : Appili begins dosing in phase 3 Covid-19 study

Appili Therapeutics said that it has dosed the first participant in the phase 3 PRESECO clinical trial for Avigan tablets (favipiravir) for the oral treatment of Covid-19. The Canadian infectious disease biopharma company Appili is involving PRA Health Sciences as a clinical research organization (CRO) for administering the Covid-19 clinical trial at 47 outpatient sites. […]

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