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Cerbios header

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molecule","graph2":"TheracosBio"}]

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Sanofi

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Pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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EMA CHMP Recommends Grant of Marketing Authorization of Insulin Aspart Biosimilars

Details:

Truvelog Mix 30 is approved and available as a 100 U/ml suspension for injection. The active substance of Truvelog Mix 30 is insulin aspart, an intermediate- or long-acting insulin which is combined with fast-acting insulin and used in diabetes.

Lead Product(s): Insulin aspart

Therapeutic Area: Endocrinology Product Name: Truvelog Mix 30

Highest Development Status: Approved Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

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Deal Type: Not Applicable February 24, 2022

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Dr. Reddy's Laboratories

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Offering a portfolio of products & services including APIs, CMO services, generics, biosimilars & differentiated formulations.

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$Dr. Reddy\'s Laboratories$

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Dr. Reddy's Laboratories Announces the Launch of Cinacalcet Tablets in the U.S. Market

Details:

Cinacalcet Tablets is a therapeutic equivalent generic version of Sensipar (cinacalcet) Tablets, approved by the U.S. Food and Drug Administration (USFDA).

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

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TheracosBio

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TheracosBio Announces FDA Approval of Brenzavvy™ (bexagliflozin) for the Treatment of Adults with Type 2 Diabetes

Details:

Brenzavvy™ (bexagliflozin) is a SGLT2 inhibitor thus, reducing renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.

Lead Product(s): Bexagliflozin

Therapeutic Area: Endocrinology Product Name: Brenzavvy

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 January 23, 2023

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Novo Nordisk

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Novo Nordisk Announces FDA Approval of Label Update for Rybelsus® (semaglutide) Allowing Use as A First-Line Option for Adults with Type 2 Diabetes

Details:

Rybelsus® (semaglutide) tablets 7 mg or 14 mg is a prescription medicine used along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes.

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 January 12, 2023

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Tetris Pharma

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Tetris Pharma Signs Service Agreement With Syneos Health

Details:

Ogluo® is a ready-to-use, ambiently stored, preparation of glucagon that has been specifically designed for patients living with diabetes with severe hypoglycaemia.

Lead Product(s): Glucagon

Therapeutic Area: Endocrinology Product Name: Ogluo

Highest Development Status: Approved Product Type: Peptide

Partner/Sponsor/Collaborator: Arecor

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement December 12, 2022

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Amryt Pharma

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European Commission Approves Mycapssa® For the Treatment of Acromegaly

Details:

Mycapssa (octreotide) is an oral prescription medicine used in the long-term maintenance treatment of acromegaly in people for whom initial treatment with octreotide or lanreotide has been effective and tolerated.

Lead Product(s): Octreotide Acetate

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 December 05, 2022

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Amryt Pharma

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Amryt Announces New Patent for Mycapssa®

Details:

Mycapssa® (octreotide capsules) is approved in the US for long-term maintenance therapy in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide.

Lead Product(s): Octreotide Acetate

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 November 30, 2022

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MacroGenics

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MacroGenics Earns $60 Million Milestone with U.S. FDA Approval of Teplizumab

Details:

Under the terms of the agreements held in 2018, Provention has acquired all rights to Tzield (teplizumab) to be further developed as PRV-031 and licensing rights to MGD010 for development as PRV-3279.

Lead Product(s): Teplizumab

Therapeutic Area: Endocrinology Product Name: Tzield

Highest Development Status: Approved Product Type: Large molecule

Partner/Sponsor/Collaborator: Provention Bio

Deal Size: $395.0 million Upfront Cash: Undisclosed

Deal Type: Agreement November 17, 2022

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Visen Pharmaceuticals

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VISEN Discloses 52-week Clinical Results for Its China Phase 3 Trial of Lonapegsomatropin

Details:

ACP-011 (lonapegsomatropin), a long-acting prodrug of unmodified somatropin is being investigated as a once-weekly injection in children with growth hormone deficiency (GHD) in China.

Lead Product(s): Lonapegsomatropin

Therapeutic Area: Endocrinology Product Name: ACP-011

Highest Development Status: Approved Product Type: Peptide

Partner/Sponsor/Collaborator: Ascendis Pharma

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 17, 2022

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Provention Bio

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FDA Approves First Drug That Can Delay Onset of Type 1 Diabetes

Details:

Tzield (teplizumab-mzwv) binds to certain immune system cells and delays progression to stage 3 type 1 diabetes. Tzield may deactivate the immune cells that attack insulin-producing cells, while increasing the proportion of cells that help moderate the immune response.

Lead Product(s): Teplizumab

Therapeutic Area: Endocrinology Product Name: Tzield

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 November 17, 2022

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