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              F. Hoffmann-La Roche

              • Development Update

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              SWITZERLAND Switzerland

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              PHARMACEUTICAL MARKETING

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              FDA Grants Priority Review to Roche’s Esbriet (Pirfenidone) for Unclassifiable Interstitial Lung Disease

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              Lead Product(s): Pirfenidone

              Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Esbriet

              Highest Development Status: Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable January 21, 2021

              Details:

              US Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and granted Priority Review for Esbriet® (pirfenidone) for the treatment of unclassifiable interstitial lung disease (UILD).

              Novartis Pharmaceuticals Corporation

              • Development Update

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              Novartis receives positive CHMP opinion for new Xolair® indication to treat severe chronic rhinosinusitis with nasal polyps

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              Lead Product(s): Omalizumab

              Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Xolair

              Highest Development Status: Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable June 26, 2020

              Details:

              If approved, Xolair will provide patients who have severe chronic rhinosinusitis with nasal polyps, not adequately controlled by intranasal corticosteroids, with the first anti-IgE antibody specifically designed to target and block IgE.

              Novartis Pharmaceuticals Corporation

              • Development Update

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              SWITZERLAND Switzerland

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              Novartis’ asthma triple heads CHMP’s latest meeting

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

              Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

              Highest Development Status: Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 01, 2020

              Details:

              Decision supported by robust efficacy and safety data from Phase III IRIDIUM study, in which once-daily Enerzair® Breezhaler® resulted in statistically significant improvements in lung function.

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