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Lead Product(s): Budesonide,Formoterol Fumarate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Symbicort Turbuhaler
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 January 26, 2021
Details:
With this approval, Symbicort Turbuhaler becomes the first dual-combination therapy approved in China for mild, moderate and severe asthma.
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Lead Product(s): Fluticasone Propionate,Salmeterol Xinafoate
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 January 15, 2021
Details:
Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces that it has temporarily paused the launch of its generic version of GlaxoSmithKline’s Advair Diskus®.
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Lead Product(s): Benralizumab
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Fasenra
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 December 22, 2020
Details:
The company has received approval from the DCGI for Fasenra (Benralizumab solution for injection in a single dose prefilled syringe30 mg/ml) for patients with severe asthma (eosinophilic asthma).
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Lead Product(s): Fluticasone Propionate,Salmeterol Xinafoate
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 December 17, 2020
Details:
Hikma announces it has received FDA approval and launched its generic version of GlaxoSmithKline’s Advair Diskus® (Fluticasone Propionate and Salmeterol Inhalation Powder, USP), 100mcg/50mcg and 250mcg/50mcg doses in the US.
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Lead Product(s): Formoterol Fumarate,Glycopyrronium Bromide,Budesonide
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 December 14, 2020
Details:
The approval by the European Commission was based on positive results from the ETHOS Phase III trial in which Trixeo Aerosphere, showed a statistically significant reduction in the rate of moderate or severe exacerbations compared with dual-combination therapies 52 weeks.
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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): 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): Budesonide,Formoterol Fumarate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Ventofor
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Bilim Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration September 01, 2020
Details:
The collaboration will support Bilim Pharmaceutical’s launch into the Turkish market of Ventofor Combi Fix, a formulation of Budesonide Formoterol for Asthma and COPD management, delivered by the PowdAir Plus Dry Powder Inhaler (DPI).
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Lead Product(s): Benralizumab
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Fasenra
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 06, 2020
Details:
AstraZeneca has revealed positive results from a Phase IIIb trial of Fasenra (benralizumab) in severe eosinophilic asthma patients.
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Lead Product(s): Budensonide,Glycopyrrolate,Formoterol Fumarate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Breztri Aerosphere
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable
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