Gilead Sciences said that the US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Veklury (remdesivir) usage in COVID-19 patients with severe renal impairment, encompassing those on dialysis. This approval positions Veklury as the sole antiviral COVID-19 treatment approved for use in all stages of renal disease. It’s estimated […]
Gilead Sciences has secured expedited approval from the US Food and Drug Administration (FDA) for its nucleotide analog Veklury (remdesivir) for the treatment of non-hospitalized patients at high risk for Covid-19 disease progression. The Covid-19 drug has been indicated for adults and adolescents. Veklury has been the antiviral standard of care for the treatment of […]
Natco Pharma has signed a royalty-free, non-exclusive, voluntary licensing agreement with Eli Lilly and Company (Lilly) for manufacturing and commercializing Baricitinib for the treatment of Covid-19 in India. With the licensing agreement signed, Natco has withdrawn the application it had filed with the Indian Patent Office, under which had sought compulsory license against Lilly for […]
Torrent Pharmaceuticals (Torrent Pharma) has signed a licensing agreement with Eli Lilly and Company with an objective to bring the latter’s baricitinib for Covid-19 treatment in India. The royalty free, non-exclusive voluntary agreement enables Torrent Pharma to manufacture and distribute baricitinib along with Lilly’s other license partners. According to Torrent Pharma, the agreement will help […]
Dr. Reddy’s Laboratories said that it has forged a royalty-free, non-exclusive voluntary licensing agreement with US pharma giant Eli Lilly and Company (Lilly) for the manufacturing and commercialization of Covid-19 drug baricitinib in India. Baricitinib in combination with remdesivir had been given restricted emergency use approval by the Indian Central Drugs Standard Control Organization (CDSCO). […]
Sun Pharmaceutical Industries (Sun Pharma) said that it has signed a royalty-free, non-exclusive voluntary licensing agreement with Eli Lilly and Company for expanding access to the latter’s baricitinib in India. The Indian pharma company Sun Pharma will manufacture and distribute baricitinib in India. Baricitinib has been granted restricted emergency use by India’s Central Drugs Standard […]
Lupin Limited said that it has signed a royalty-free, limited, non-exclusive voluntary licensing agreement with Eli Lilly and Company (Lilly) for manufacturing and selling the latter’s Baricitinib in India. Baricitinib is an oral JAK1/JAK2 inhibitor for which India’s Central Drugs Standard Control Organization (CDSCO) had been given restricted emergency use in combination with Remdesivir for […]
Natco Pharma has secured emergency use approval for Baricitinib from India’s Central Drugs Standard Control Organization (CDSCO) for the treatment of Covid-19. The Indian pharma company has been given the nod for Lilly’s oral JAK1/JAK2 inhibitor in 1mg, 2mg and 4mg strengths in combination with Remdesivir. Natco Pharma said that it will be seeking a […]
Spanish pharma company Grifols said that the phase 3 ITAC clinical trial assessing hyperimmune globulins as a treatment for patients hospitalized with Covid-19 has failed to meet its primary endpoints. ITAC expands to Inpatient Treatment with Anti-Coronavirus Immunoglobulin. Also called INSIGHT-013, the late-stage trial was sponsored and supported by the US National Institute of Allergy […]
Humanigen said that lenzilumab has delivered a clinically meaningful impact on the recovery of patients hospitalized with Covid-19, as per the interim data of a phase 3 trial. According to the US biopharma company, the interim analysis for sizing and powering, an estimated 37% more recoveries were seen in the lenzilumab arm of the randomized, […]