Lead Product(s) : Insulin Glargine,Lixisenatide
Therapeutic Area : Endocrinology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Sanofi Launches New Long-Acting Insulin Drug in India
Details : Soliqua is a combination of insulin glargine, a basal insulin analog, and lixisenatide, a GLP-1 receptor agonist. It is indicated as treatment to improve glycemic control as an adjunct to diet and exercise, in adults with obesity and type 2 diabetes.
Product Name : Soliqua
Product Type : Peptide
Upfront Cash : Inapplicable
March 27, 2023
Lead Product(s) : Insulin Glargine,Lixisenatide
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Insulin Glargine,Lixisenatide
Therapeutic Area : Endocrinology
Study Phase : Undisclosed
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
New Soliqua® Data Shows Improved Blood Sugar Control Without Weight Gain Versus Premixed Insulin
Details : Participants were randomized to switch from their prior insulin to either Soliqua once daily or premixed insulin twice daily, with starting doses determined and adjusted weekly. Any metformin or SGLT-2i treatment was maintained through the study period.
Product Name : Soliqua
Product Type : Peptide
Upfront Cash : Inapplicable
June 28, 2021
Lead Product(s) : Insulin Glargine,Lixisenatide
Therapeutic Area : Endocrinology
Highest Development Status : Undisclosed
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Study Phase : Undisclosed
Sponsor : Civica Rx
Deal Size : Undisclosed
Deal Type : Partnership
Civica Welcomes Ypsomed as Injection Pen Partner for Its Affordable Insulin Initiative
Details : Civica plans to produce three insulin biosimilars – glargine, lispro and aspart – each of which will be available both in vials and prefilled pens, and to ensure redundancy of supply, Ypsomed will provide injector dosing pens from their manufacturing...
Product Name : Undisclosed
Product Type : Peptide
Upfront Cash : Undisclosed
January 31, 2023
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Highest Development Status : Undisclosed
Sponsor : Civica Rx
Deal Size : Undisclosed
Deal Type : Partnership
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Study Phase : Approved FDF
Sponsor : HEC Group
Deal Size : Inapplicable
Deal Type : Inapplicable
Lannett Announces Subject Dosing Complete For Pivotal Clinical Trial Of Biosimilar Insulin Glargine
Details : Biosimilar insulin glargine is the most significant opportunity in the company's current pipeline. Recent estimated U.S. sales of long acting insulin glargine (Glaricon) are approximately $10 billion annually, according to IQVIA, although manufacturer re...
Product Name : Glaricon
Product Type : Peptide
Upfront Cash : Inapplicable
August 31, 2022
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Sponsor : HEC Group
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Study Phase : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lannett Initiates Pivotal Clinical Trial for Biosimilar Insulin Glargine
Details : The first study, which the FDA reviewed, suggested that the HEC insulin glargine product would be biosimilar to US-approved Lantus® (the reference biologic) in terms of meeting the study's pharmacokinetics (PK) and pharmacodynamics (PD) endpoints.
Product Name : Glaricon
Product Type : Peptide
Upfront Cash : Inapplicable
March 29, 2022
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Highest Development Status : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Study Phase : Preclinical
Sponsor : GeneSys Biologics
Deal Size : Undisclosed
Deal Type : Financing
Civica Takes First Foray Into Biosimilars With GeneSys Insulins Partnership
Details : Civica will produce three insulins – glargine, lispro and aspart (biologics corresponding to, and interchangeable with, Lantus, Humalog and Novolog respectively) – each of which will be available both in vials and prefilled pens.
Product Name : Insulin Glargine-Generic
Product Type : Peptide
Upfront Cash : Undisclosed
March 03, 2022
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Highest Development Status : Preclinical
Sponsor : GeneSys Biologics
Deal Size : Undisclosed
Deal Type : Financing
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Study Phase : Approved FDF
Sponsor : Biocon
Deal Size : $3,335.0 million
Deal Type : Acquisition
Details : The acquisition of biosimilars assets of Viatris significantly strengthens BBL’s position in providing affordable access to patients through its portfolio in diabetes, oncology, immunology and other non-communicable diseases including Semglee (Insulin ...
Product Name : Semglee
Product Type : Peptide
Upfront Cash : $2,335.0 million
February 28, 2022
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Sponsor : Biocon
Deal Size : $3,335.0 million
Deal Type : Acquisition
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Study Phase : Approved FDF
Sponsor : Biocon
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The Semglee® (insulin glargine injection), is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus and is packaged in prefille...
Product Name : Semglee
Product Type : Peptide
Upfront Cash : Inapplicable
January 18, 2022
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Sponsor : Biocon
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Viatris Wins Court Decisions on Sanofi Appeals of Lantus® Patent Invalidations
Details : Decisions reaffirm Viatris' ability to provide patient access to interchangeable for the reference brand, Lantus®, allowing for substitution at the pharmacy counter. Semglee® is indicated to help control high blood sugar with type 1 diabetes and type 2...
Product Name : Semglee
Product Type : Peptide
Upfront Cash : Inapplicable
December 29, 2021
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Study Phase : Approved FDF
Sponsor : Biocon
Deal Size : Inapplicable
Deal Type : Inapplicable
Viatris and Biocon Biologic Announce Approval for First Interchangeable Biosimilar Treatment
Details : Semglee is indicated to control high blood sugar in adults with Type 2 diabetes and adults and pediatric patients with Type 1 diabetes. It is not recommended for the treatment of diabetic ketoacidosis.
Product Name : Semglee
Product Type : Peptide
Upfront Cash : Inapplicable
July 28, 2021
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Sponsor : Biocon
Deal Size : Inapplicable
Deal Type : Inapplicable
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