India gave emergency use authorization for a Covid-19 antibody drug cocktail developed by Roche and Regeneron, expanding the company’s arsenal of drugs to battle a massive second wave of infections. The decision was taken based on data filed with the U.S. regulators and the scientific opinion of a European regulatory panel, Roche’s India distribution partner for the drug, Cipla, said on May 5.
The tenth annual Pharmaceutical Innovation Index, released April 21, sees Eli Lilly top the industry for the first time. The Pharmaceutical Invention Index, a ranking of the industry’s best pipelines, rated Bristol Myers Squibb as No. 1.
Regeneron Pharmaceuticals announced results from the company’s Phase III trial of recently infected asymptomatic Covid-19 patients for the REGEN-COV (casirivimab with imdevimab) antibody cocktail.
With the increase of multiple variants of Covid-19 across the United States, the U.S. Food and Drug Administration will limit the use of monoclonal antibody treatments developed by Regeneron and Eli Lilly due to concerns the medications are not effective against these new strains.
Regeneron Pharmaceuticals said an independent panel found the company’s Covid-19 antibody cocktail to have “clear clinical efficacy” in reducing the rates of hospitalization and deaths in patients.
Regeneron and Sanofi’s checkpoint inhibitor Libtayo (cemiplimab-rwlc) won U.S. Food and Drug Administration approval for the first-line treatment of patients with advanced non-small cell lung cancer whose tumors have high PD-L1 expression.
In a long-running court battle over PCSK9 antibodies, Amgen lost the company’s bid to uphold patent claims for the cholesterol drug Repatha against rival drug Praluent, developed by Sanofi and Regeneron.
Laboratory testing found that Regeneron Pharmaceuticals Inc.’s Covid-19 antibody cocktail can combat a coronavirus variant first found in South Africa, but a similar drug from Eli Lilly and Co. is inactive against it, according to a study.
Regeneron Pharmaceuticals announced positive initial data from the company’s ongoing Phase III trial of the antibody cocktail, REGEN-COV, as a passive vaccine to prevent Covid-19 in people at high risk of infection from household exposure.
Regeneron Pharmaceuticals Inc. said initial data from an ongoing study of the company’s experimental antibody cocktail for use in hospitalized Covid-19 patients requiring low-flow oxygen show the therapy was sufficiently effective to warrant continuing the trial.
