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F. Hoffmann-La Roche

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

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).

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

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Novartis Pharmaceuticals Corporation

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

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.

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

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Novartis Pharmaceuticals Corporation

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Novartis’ asthma triple heads CHMP’s latest meeting

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.

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

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

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Propeller Health

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 01, 2020

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