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Lead Product(s): Somatrogon
Therapeutic Area: Endocrinology Product Name: PF-06836922
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 04, 2021
Details:
The submission is backed by global Phase 3 trial evaluating the safety and efficacy of somatrogon administered once weekly to pediatric patients with GHD. This study met its primary endpoint of non-inferiority compared to GENOTROPIN® for injection administered once daily.
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Lead Product(s): Teplizumab
Therapeutic Area: Endocrinology Product Name: PRV-031
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: SVB Leerink
Deal Size: $100.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering January 13, 2021
Details:
Provention Bio intends to use its net proceeds from the public offering for development activities for PRV-015, PRV-101, and PRV-3279; potential acquisition or in-licensing of other product candidates; and for other general corporate purposes.
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Lead Product(s): TransCon hGH
Therapeutic Area: Endocrinology Product Name: TransCon hGH
Highest Development Status: Phase III Product Type: Peptide
Partner/Sponsor/Collaborator: Sequoia China
Deal Size: $150.0 million Upfront Cash: Undisclosed
Deal Type: Series B Financing January 09, 2021
Details:
Proceeds of the Series B financing will be used to accelerate the clinical development of the potential best-in-class portfolio drug candidates and to build a strong foundation for commercialization.
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Lead Product(s): Testosterone Undecanoate
Therapeutic Area: Endocrinology Product Name: Kyzatrex
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 05, 2021
Details:
KYZATREX® has generated strong results in both safety and efficacy studies for KYZATREX® for treatment of primary and secondary hypogonadism in men.
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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 December 29, 2020
Details:
Novo Nordisk filed a label extension application to the European Medicines Agency (EMA) for the existing marketing authorisation for Ozempic®, a once-weekly glucagon-like peptide-1 (GLP-1) analogue, to introduce a new dose of 2.0 mg.
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Lead Product(s): Glucagon
Therapeutic Area: Endocrinology Product Name: Ogluo
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 December 11, 2020
Details:
The positive Opinion is based on the results from a Phase 3, multi-center, randomized controlled, non-inferiority study to evaluate the liquid stable glucagon auto-injector as a treatment for severe hypoglycemic events compared with Novo Nordisk’s GlucaGen® HypoKit®.
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Lead Product(s): Tirzepatide
Therapeutic Area: Endocrinology Product Name: LY3298176
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 December 09, 2020
Details:
Using the efficacy estimandi, the highest dose of tirzepatide led to an A1C reduction of 2.07 percent and reduced body weight by 9.5 kg (11.0 percent). More than half (51.7 percent) of participants in the treatment arm achieved an A1C less than 5.7 percent.
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