FDA-&-EMA-New-Drug Approvals(Mid-2020 Recap)-insert
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            Lead Product(s): Lonapegsomatropin

            Therapeutic Area: Endocrinology Product Name: TransCon hGH

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 06, 2020

            Details:

            Paediatric Committee of the European Medicines Agency supports the investigation of TransCon hGH for treatment of growth hormone deficiency in the pediatric population from 6 months to less than 18 years of age.

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            Lead Product(s): Lonapegsomatropin

            Therapeutic Area: Endocrinology Product Name: TransCon hGH

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 26, 2020

            Details:

            TransCon hGH is designed to maintain the same mode of action as daily hGH therapies by releasing the same growth hormone molecule, somatropin.

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            Lead Product(s): Dasiglucagon

            Therapeutic Area: Endocrinology Product Name: HypoPal

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 14, 2020

            Details:

            The dasiglucagon HypoPal® rescue pen is under FDA review as a potential fast and effective treatment of severe hypoglycemia in diabetes.

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            Lead Product(s): Lonapegsomatropin

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 08, 2020

            Details:

            The fliGHt Trial data presented at ENDO Online demonstrate that subjects taking daily somatropin can safely switch to TransCon hGH, an investigational long-acting prodrug that releases somatropin, with consistent and predictable efficacy.

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            Lead Product(s): Dasiglucagon

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 22, 2020

            Details:

            The dasiglucagon HypoPal® rescue pen New Drug Application represents a major milestone in Zealand Pharma’s efforts to bring life changing therapies to people with diabetes.

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            Lead Product(s): Lonapegsomatropin

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 15, 2020

            Details:

            FDA has granted Orphan Drug Designation to TransCon hGH, as a treatment for growth hormone deficiency. There is no approved long-acting growth hormone treatment on the market in the U.S. or Europe.

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            Lead Product(s): Dasiglucagon

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 30, 2020

            Details:

            Single mini-doses of dasiglucagon effectively reduced time spent in hypoglycemia after meals in individuals who have undergone bariatric surgery.