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Find Clinical Drug Development Pipelines & Deals | PipelineProspector

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            Lead Product(s): Indacaterol acetate,Glycopyrronium Bromide,Mometasone Furoate

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Enerzair

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 07, 2020

            Details:

            High-dose, once-daily Enerzair® Breezhaler® [IND/GLY/MF] reduced asthma exacerbation rates by 21% (moderate or severe) and 31% (severe) versus medium-dose, over 52 weeks.

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            Lead Product(s): Omalizumab

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Xolair

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 13, 2020

            Details:

            U.S FDA accepted the Roche's supplemental Biologics License Application (sBLA) for a new self-administration option for Xolair® (omalizumab) across all approved US indications.

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            Lead Product(s): Indacaterol acetate,Glycopyrronium Bromide,Mometasone Furoate

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Enerzair Breezhaler

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 07, 2020

            Details:

            European Commission has approved once-daily Enerzair® Breezhaler® (QVM149; IND/GLY/MF) in the EU, the first-in-class LABA/LAMA/ICS fixed-dose combination for patients whose asthma is uncontrolled with LABA/ICS1.