Daily Top News – July 9, 2020

July 9, 2020

Olumiant (baricitinib) / Incyte, Eli Lilly, University of Colorado
Drug approval reports (FDA) – Jul 9, 2020 – Label update for Olumiant approved on 8th Jul, 2020. 
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tralokinumab (CAT 354) / LEO Pharma, AstraZeneca
LEO Pharma announces U.S. Food and Drug Administration (FDA) acceptance of Biologics License Application (BLA) for tralokinumab for the treatment of adults with moderate-to-severe atopic dermatitis (Businesswire) – Jul 9, 2020 – “LEO Pharma A/S…today announced that the Biologics License Application (BLA) for tralokinumab for the treatment of adults with moderate-to-severe atopic dermatitis (AD) has been accepted for review by the U.S. Food and Drug Administration (FDA)….Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date in the second quarter of 2021….The BLA submission is based on data from the pivotal ECZTRA 1, 2 and ECZTRA 3 Phase 3 studies evaluating the safety and efficacy of tralokinumab.”

 

Keytruda (pembrolizumab) / Merck (MSD)
FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA (pembrolizumab) for Second-Line Treatment of Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (Businesswire) – Jul 9, 2020 – “Merck…announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). This sBLA is based on data from the pivotal Phase 3 KEYNOTE-204 trial…The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Oct. 30, 2020.”

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