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Lead Product(s): TransCon PTH
Therapeutic Area: Endocrinology Product Name: TransCon PTH
Highest Development Status: Phase III Product Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 23, 2021
Details:
PaTH Forward is a global, phase 2, randomized, double-blind, placebo-controlled group trial evaluating the safety and efficacy of three fixed doses of TransCon PTH. TransCon PTH continues to be well-tolerated.
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Lead Product(s): Semaglutide
Therapeutic Area: Endocrinology Product Name: Ozempic
Highest Development Status: Phase III Product Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 22, 2021
Details:
US Food and Drug Administration (FDA) has issued a Refusal to File letter covering the label expansion application for once-weekly semaglutide 2.0 mg for the treatment of type 2 diabetes which was filed on 20 January 2021.
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Lead Product(s): Semaglutide
Therapeutic Area: Endocrinology Product Name: Ozempic
Highest Development Status: Phase III Product Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 20, 2021
Details:
The submission is based on the results from the SUSTAIN FORTE trial, which included 961 T2D patients in need of treatment intensification. People treated with semaglutide 2.0 mg achieved a significant and superior reduction in HbA1c compared to semaglutide 1.0 mg.
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Lead Product(s): Semaglutide
Therapeutic Area: Endocrinology Product Name: Ozempic
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