FDA-&-EMA-New-Drug Approvals(Mid-2020 Recap)-insert
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            Lead Product(s): Budensonide,Glycopyrrolate,Formoterol

            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 Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 24, 2020

            Details:

            The UK pharma giant has received approval for its Breztri Aerosphere, formerly dubbed PT010, culminating the drug’s bumpy regulatory journey in a win. Now, AstraZeneca can challenge the leader in the area — GlaxoSmithKline’s Trelegy — without obstacle.

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            Lead Product(s): Brompheniramine Maleate,Dextromethorphan Hydrobromide,Phenylephrine Hydrochloride

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Dimetapp

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Foundation Consumer Healthcare

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement July 16, 2020

            Details:

            This diverse portfolio of products includes Breathe Right® Nasal Strips, the world’s #1 nasal strip, and Children’s Dimetapp®, the #1 pharmacist-recommended brand for children's cough and cold products, as well as Anbesol®, Alavert®, Dristan®, Primatene Tablets® and FiberCon®.

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            Lead Product(s): Budensonide,Glycopyrrolate,Formoterol

            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 Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 24, 2020

            Details:

            Results from the positive Phase III ETHOS trial showed AstraZeneca’s triple-combination therapy Breztri Aerosphere demonstrated a statistically significant reduction in moderate or severe exacerbations compared with 2 dual-combination therapies in moderate to very severe COPD.

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            Lead Product(s): Formoterol,Glycopyrronium Bromide

            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 May 18, 2020

            Details:

            Approval by the NMPA was based on positive results from the Phase III PINNACLE 4 trial1 in which Bevespi Aerosphere demonstrated a statistically significant improvement in lung function as compared to its monotherapy components and placebo.

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            Lead Product(s): Aclidinium Bromide

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Circassia Pharmaceuticals

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Termination April 09, 2020

            Details:

            On completion of the Transaction, AstraZeneca will acquire the U.S. commercial rights to Tudorza® and Duaklir® together with certain ancillary rights and assets, from Circassia.