Aurobindo Pharma has secured consent from the Drugs Controller General of India (DCGI) for manufacturing and distributing its generic version of Covid drug Molnupiravir under the brand name — Molnaflu. The Indian pharma company had previously acquired the licensing rights for the generic version of MSD and Ridgeback Biotherapeutics’ Molnupiravir. A non-exclusive voluntary licensing agreement […]
Dr. Reddy’s Laboratories has secured permission from the Drug Controller General of India (DCGI) for importing the Sputnik V vaccine into India under emergency use authorization (EUA). In February 2021, Dr. Reddy’s Laboratories commenced the process to seek the emergency use authorization for the Russian Covid-19 vaccine from the Indian drug regulator. Last September 2020, […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
Eli Lilly and Company (Lilly) has signed a $375 million deal with the US government for the supply of 300,000 vials of bamlanivimab (LY-CoV555) 700mg, an investigational neutralizing antibody for the treatment of Covid-19. LY-CoV555 is the first antibody candidate to come out from Lilly’s collaboration with AbCellera Biologics, which was announced in March this […]