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Ridgeback Biotherapeutics LP

https://www.ridgebackbio.com/

Latest From Ridgeback Biotherapeutics LP

COVID-19 Will Forever Change Workplace, But Not Necessarily For The Better, Merck’s Frazier Says

Limiting interactions to two-dimensional settings will hinder collaboration, innovation and the mentoring of younger employees, Merck & Co. CEO Kenneth Frazier says. Frazier, who will retire in June, is looking forward to returning to public service but says "politics with a capital P is not my thing."

Coronavirus COVID-19 Leadership

US FDA's Ebola Drug Approvals Showcase Efficiencies With Master Protocols

Agency approved Regeneron’s monoclonal antibody cocktail Inmazeb and Ridgeback’s mAB Ebanga on data from a multi-arm, adaptive trial in which several investigational agents were independently compared to a control group. Efficacy for both drugs was demonstrated on a mortality endpoint, with lingering uncertainties to be addressed through postmarketing studies.

Drug Review Profile Approvals

Inmazeb Brought Regeneron A Priority Review Voucher, But Not The Type It Wanted

Sponsor preferred a tropical disease voucher because it could be redeemed for a supplemental application, but the FDA awarded a voucher under the medical countermeasures program, which prohibits redemption for supplements; agency says it takes a case-by-case approach to deciding whether tropical disease and rare pediatric disease vouchers can be redeemed for supplements.

Drug Review Profile Approvals

Ebanga Clinical Development Timeline

Chronicle of the development and review of Ridgeback Biotherapeutics’ ansuvimab-zykl for treatment of Ebola infection.

Drug Review Profile Approvals
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