


Details:
Once-daily Enerzair® Breezhaler® (QVM149; IND/GLY/MF) met primary endpoint, demonstrating non-inferiority to a free combination of twice-daily Sal/Flu plus once-daily Tio in improving quality of life in people with uncontrolled asthma.
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: Novartis Pharmaceuticals Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 05, 2020
Details:
FDA has accepted the company’s supplemental New Drug Application (sNDA) for FETROJA® (cefiderocol) and granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) date of September 27, 2020.
Lead Product(s): Cefiderocol,Linezolid
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 June 01, 2020
Details:
If the EC follows this recommendation and approves Enerzair® Breezhaler®, it will become the first LABA/long-acting muscarinic antagonist (LAMA)/ICS fixed-dose combination for uncontrolled asthma patients.
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: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 01, 2020