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Latest From Sanofi

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

China Lays Out Requirements For Biosimilar Extrapolation

In what could be a blow to some aspiring developers eyeing the nascent but growing biosimilars market in China, new rules lay out when extrapolation of approved indications of reference biologics will be allowed, meaning this will not be automatic.

China Coronavirus COVID-19

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
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Company Information

  • Industry
  • Pharmaceuticals
  • Pharmaceuticals
    • Specialty Pharmaceuticals
    • Vaccines
  • Other Names / Subsidiaries
    • Ablynx N.V.
    • Acambis PLC
    • Bioverativ Inc. (True North Therapeutics, Inc.)
    • BiPar Sciences Inc.
    • BMP Sunstone Corporation
    • Canderm Pharma Inc.
    • Chattem, Inc.
    • Connaught Laboratories Ltd.
    • Fisons Ltd.
    • Fovea Pharmaceuticals, SA
    • Genfar S.A.
    • Genzyme Corporation
    • Groupe Sanofi
    • Hoechst Marion Roussel
    • Pluromed
    • Principia Biopharma Inc. Protein Sciences Corporation
    • Rhone-Poulenc Rorer
    • Sanofi-Aventis
    • Sanofi-aventis Groupe
    • Sanofi Pasteur MSD
    • Shantha
    • Synthorx, Inc. (THOR)
    • TargeGen, Inc.
    • Thunder Acquisition
    • Avigen Inc.
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