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Lead Product(s): Cinacalcet
Therapeutic Area: Endocrinology 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 October 01, 2020
Details:
Cinacalcet Tablets is a therapeutic equivalent generic version of Sensipar (cinacalcet) Tablets, approved by the U.S. Food and Drug Administration (USFDA).
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Lead Product(s): Insulin Lispro
Therapeutic Area: Endocrinology Product Name: Lyumjev
Highest Development Status: Approved Product Type: Peptide
Partner/Sponsor/Collaborator: Eli Lilly
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership October 07, 2020
Details:
Companies will partner to promote Lyumjev, Lilly's new rapid-acting insulin, with Dexcom G6 Continuous Glucose Monitoring (CGM), highlighting the benefits of using each .
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Lead Product(s): Hydrocortisone
Therapeutic Area: Endocrinology Product Name: Alkindi
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 29, 2020
Details:
ALKINDI SPRINKLE is the first and only FDA-approved granular hydrocortisone formulation for adrenocortical insufficiency specifically designed for children.
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Lead Product(s): Sildenafil Citrate
Therapeutic Area: Endocrinology Product Name: Viagra
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Farmalider SA
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition September 29, 2020
Details:
Aspargo’s Sildenafil Oral Spray is an oral liquid suspension of sildenafil citrate administered via a spray pump that dispenses 12.5 mg of sildenafil citrate per push of the pump (referred to as ASP-001) or via an individual single liquid unit dispensing 100 mg per unit.
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Lead Product(s): Dulaglutide
Therapeutic Area: Endocrinology Product Name: Trulicity
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 September 03, 2020
Details:
The approval expands the label of once-weekly Trulicity to include 3.0 mg and 4.5 mg doses based on data from AWARD-11. The phase 3 trial showed the additional doses led to further benefits in A1C and body weight reduction when compared to Trulicity 1.5 mg.
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Lead Product(s): Semaglutide
Therapeutic Area: Endocrinology Product Name: Rybelsus
Highest Development Status: Approved Product Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 01, 2020
Details:
Rybelsus (semaglutide tablets) is the world’s first and only oral GLP-1 receptor agonist (RA), which physicians in the UK, including GPs, can now prescribe for adults with insufficiently controlled type II diabetes to improve glycaemic control.
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Lead Product(s): Insulin
Therapeutic Area: Endocrinology Product Name: MiniMed 770G
Highest Development Status: Approved Product Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 01, 2020
Details:
The 770G System is a first-of-a-kind device for patients aged 2 to 6 years. It is the first legally marketed device that can automatically adjust insulin delivery based on continuous glucose monitor values for this patient population.
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Lead Product(s): Octreotide
Therapeutic Area: Endocrinology Product Name: Mycapssa
Highest Development Status: Approved Product Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 31, 2020
Details:
MYCAPSSA, the first and only oral somatostatin analog, approved by the U.S. FDA on June 26, 2020 for the long-term maintenance treatment of patients with acromegaly who have responded to and tolerated treatment with octreotide or lanreotide.
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Lead Product(s): Osilodrostat
Therapeutic Area: Endocrinology Product Name: Isturisa
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 28, 2020
Details:
Data from the Phase III LINC-3 study, published in Lancet Diabetes & Endocrinology, demonstrate that Isturisa® (osilodrostat) rapidly decreases mean urinary free cortisol (mUFC) in patients with Cushing’s disease.
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Lead Product(s): Levothyroxine Sodium
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Cediprof
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement July 16, 2020
Details:
The companies have entered into an interim exclusive supply and distribution agreement for Cediprof's FDA approved Levothyroxine Sodium Tablets USP. Lannett to Commence Marketing on August 3, 2020.
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