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Find Approved Drugs for Pulmonary/Respiratory Diseases in Clinical Development

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            Lead Product(s): Dupilumab

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Dupixent

            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 18, 2020

            Details:

            Health Canada approved a new indication for Dupixent, as an add-on maintenance treatment with intranasal corticosteroids in adult patients with severe chronic rhinosinusitis with nasal polyposis (CRSwNP) inadequately controlled by systemic corticosteroids and/or surgery.

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            Lead Product(s): Nintedanib Esylate

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Nintib

            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 October 20, 2020

            Details:

            Available as 100 mg and 150 mg capsules, it will be marketed under the brand name Nintib.

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            Lead Product(s): Budensonide,Glycopyrrolate,Formoterol Fumarate

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Trixeo Aerosphere

            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 October 19, 2020

            Details:

            Trixeo Aerosphere, a triple-combination therapy, is approved under the brand name Breztri Aerosphere in Japan, China and the US for patients with COPD. Recommendation of triple-combination therapy based on positive results from ETHOS and KRONOS Phase III trials.

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            Lead Product(s): Nintedanib Esylate

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

            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 October 14, 2020

            Details:

            In a recently published INBUILDtm trial, Nintedanib showed significantly lower annual rate of decline in FVC (Forced Vital Capacity) – a measure of lung health – with various progressive fibrosing interstitial lung diseases.

            Zydus Cadila

            • Development Update

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            Lead Product(s): Formoterol Fumarate,Glycopyrrolate

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Forglyn

            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 October 08, 2020

            Details:

            The administration of the two drugs Formoterol fumarate (LABA) + Glycopyrrolate (LAMA) in a single inhalation will improve outcomes due to the desired synergistic effect of the two drugs and a better adherence to the treatment.

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            Lead Product(s): Fluticasone

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Aermony RespiClick

            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 October 05, 2020

            Details:

            Aermony RespiClick™ (fluticasone propionate inhalation powder) is packaged in an innovative device with features designed to simplify the administration of inhaled therapy and reduce patient error and confusion.

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            Lead Product(s): Cefiderocol,Linezolid

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Fetroja

            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 28, 2020

            Details:

            U.S.FDA has approved a supplemental New Drug Application for FETROJA® (cefiderocol) for the treatment of patients 18 years of age or older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).

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            Lead Product(s): Fluticasone,Salmeterol Xinafoate

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: AirDuo

            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 21, 2020

            Details:

            AirDuo® Digihaler® and ArmonAir® Digihaler® are part of Teva’s Digihaler® portfolio,including ProAir® Digihaler®, the first and only digital rescue inhaler indicated in patients 4 years or older for the treatment of bronchospasm who have reversible obstructive airway disease.

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            Lead Product(s): Fluticasone Furoate,Umeclidinium Bromide,Vilanterol

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Trelegy Ellipta

            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 09, 2020

            Details:

            FDA has approved a new indication for Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol ‘FF/UMEC/VI’) for the treatment of asthma in patients aged 18 years and older adding to its current license for use in patients with COPD.

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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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