Category: Casirivimab

• Roche confirms that the US govt. will purchase additional supply of Regeneron’s Ab cocktail for use in non-hospitalized COVID-19 patients as part of Operation Warp Speed
• The agreement additional supply of Regeneron’s Ab cocktail for use in non-hospitalized COVID-19 patients as part of Operation Warp Speed.
• The cocktail has received the US FDA’s EUA for recently diagnosed, high-risk, mild to moderate COVID-19 patients. Roche & Regeneron collaborated to develop and manufacture casirivimab and imdevimab under which Regeneron is distributing it in the US while Roche will be responsible for distribution outside the US

Click here ­to­ read full press release/ article | Ref: Roche | Image: Bloomberg

The post The US Government to Purchase Additional Doses of Regeneron’s Casirivimab and Imdevimab to Combat COVID-19 first appeared on PharmaShots.

• Chugai get an exclusive development and commercialization agreement in Japan for Roche’s Ab cocktail of casirivimab and imdevimab to combat COVID-19
• Earlier, Roche & Regeneron collaborated for the development & commercialization of Ab cocktail where Regeneron will distribute the treatment in the US while Roche will be lead manufacturing and distribution activities outside the US
• The combination regimen is being studied globally in a P-II/III study for patients with COVID-19 who require hospitalization, in P-II/III clinical study for non-hospitalized patients with COVID-19, and P-III clinical study for prevention of infection in COVID-19 household contacts

Click here ­to­ read full press release/ article | Ref: Chugai | Image: Wikipedia

The post Chugai In-Licenses Roche’s Antibody Cocktail for COVID-19 in Japan first appeared on PharmaShots.

• Penn allied with Regeneron to investigate Ab cocktail (casirivimab & imdevimab) to prevent COVID-19 infection when delivering intranasally via AAV vectors
• The collaboration b/w Wilson and Penn’s GTP and Regeneron will have two phases. The first phase will include the validation of the effectiveness of Abs delivered via AAV in a large animal model challenge study. If successful, the research team will complete studies to support the filing of IND to the FDA
• Regeneron’s Ab cocktail (casirivimab & imdevimab) is studied in clinical trials for the prevention of COVID-19 and has received the US FDA’s EUA in certain high-risk patients with mild to mod. COVID-19

Click here ­to­ read full press release/ article | Ref: Penn Medicine | Image: LaingBuisson News

The post Regeneron Collaborates with Penn to Explore Intranasal Delivery of COVID-19 Ab Cocktail via Gene Therapy Platform first appeared on PharmaShots.

• The US FDA has issued a EUA for casirivimab (1,200mg) + imdevimab (1,200mg) administered together for mild to mod. COVID-19 in adults and pediatric patients aged ≥12yrs. weighing at least 40kg [~88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19
• The EUA is based on a P-II study that showed a reduction in hospitalization or ER visits in patients at high risk for disease progression within 28days after treatment and a reduction in viral loads
• Initial doses of Ab cocktail will be made available to ~300,000 patients, with no medication out-of-pocket costs, under the US government allocation program

Click here ­to­ read full press release/ article | Ref: Regeneron | Image: Fox Business

The post Regeneron’s Casirivimab and Imdevimab Receive the US FDA’s EUA as the First Combination Therapy for COVID-19 first appeared on PharmaShots.