X
API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
0
USA (Orange Book)
0
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
EDQM
0
USP
0
JP
0
Other Listed Suppliers
0
0
Details:
QVM149 combines the bronchodilation of indacaterol acetate (a LABA) and the antimuscarinic effects of glycopyrronium bromide (a LAMA) with mometasone furoate in a precise once-daily formulation, delivered via the dose-confirming Breezhaler® device.
Lead Product(s): Indacaterol Acetate,Glycopyrronium Bromide,Mometasone Furoate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Enerzair Breezhaler
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 07, 2020
RDD 2024
Not Confirmed
Contact SupplierDetails:
New post hoc analysis results from the phase III IRIDIUM study that suggests that using Enerzair Breezhaler as a step-up therapy from medium-dose LABA/ICS provides benefit beyond increasing ICS dose alone.
Lead Product(s): Indacaterol Acetate,Glycopyrronium Bromide,Mometasone Furoate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Enerzair Breezhaler
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 03, 2021
Details:
Under the Agreement, Valeo will be responsible for medical and commercial activities for Enerzair® Breezhaler® and Atectura® Breezhaler® for an initial 8 year period.
Lead Product(s): Indacaterol Acetate,Mometasone Furoate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Atectura Breezhaler
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Valeo Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement March 29, 2021
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.
Lead Product(s): Indacaterol Acetate,Glycopyrronium Bromide,Mometasone Furoate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Enerzair Breezhaler
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 07, 2020
Details:
Patients using Enerzair® and Atectura® Breezhaler® to manage their uncontrolled asthma in Japan will have the option to enroll in Propeller’s digital health platform to help manage their condition.
Lead Product(s): Indacaterol Acetate,Glycopyrronium Bromide,Mometasone Furoate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Enerzair Breezhaler
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration August 26, 2020
Details:
European Commission approves once-daily Enerzair® Breezhaler® in the EU, the first-in-class LABA/LAMA/ICS fixed-dose combination for patients whose asthma is uncontrolled with LABA/ICS1.
Lead Product(s): Indacaterol Acetate,Glycopyrronium Bromide,Mometasone Furoate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Enerzair Breezhaler
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 07, 2020
Details:
For the first time in Japan, a new digital device combining a sensor with the Breezhaler® inhaler is being made available. Announcement by Novartis Pharma K. K. highlights key milestone for once-daily Enerzair® (IND/GLY/MF) complete with new sensor-enabled Breezhaler® device.
Lead Product(s): Indacaterol Acetate,Glycopyrronium Bromide,Mometasone Furoate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Enerzair Breezhaler
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 29, 2020
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 IIIProduct 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:
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 IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Propeller Health
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 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 IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 01, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
