Lead Product(s) : Insulin Glargine,Lixisenatide
Therapeutic Area : Endocrinology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Soliqua
Molecule Type : Peptide
Upfront Cash : Not Applicable
March 27, 2023
Lead Product(s) : Insulin Glargine,Lixisenatide
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Insulin Glargine,Lixisenatide
Therapeutic Area : Endocrinology
Study Phase : Undisclosed
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Soliqua
Molecule Type : Peptide
Upfront Cash : Not Applicable
June 28, 2021
Lead Product(s) : Insulin Glargine,Lixisenatide
Therapeutic Area : Endocrinology
Highest Development Status : Undisclosed
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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...
Brand Name : Undisclosed
Molecule 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
Sponsor : HEC Group
Deal Size : Not Applicable
Deal Type : Not Applicable
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...
Brand Name : Glaricon
Molecule Type : Peptide
Upfront Cash : Not Applicable
August 31, 2022
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Sponsor : HEC Group
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Study Phase : Phase I
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : HEC-Glargine
Molecule Type : Peptide
Upfront Cash : Not Applicable
March 29, 2022
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Highest Development Status : Phase I
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Insulin Glargine-Generic
Molecule 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
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 ...
Brand Name : Semglee
Molecule Type : Peptide
Upfront Cash : $2,335.0 million
February 28, 2022
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Sponsor : Biocon
Deal Size : $3,335.0 million
Deal Type : Acquisition
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Study Phase : Approved
Sponsor : Biocon
Deal Size : Not Applicable
Deal Type : Not Applicable
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...
Brand Name : Semglee
Molecule Type : Peptide
Upfront Cash : Not Applicable
January 18, 2022
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Sponsor : Biocon
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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...
Brand Name : Semglee
Molecule Type : Peptide
Upfront Cash : Not Applicable
December 29, 2021
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Study Phase : Approved
Sponsor : Biocon
Deal Size : Undisclosed
Deal Type : Agreement
Details : Under the terms of this agreement, Tabuk Pharmaceuticals will hold the marketing authorisation for select speciality products including Glaricon and be responsible to register, importing, and promoting them in Saudi Arabia and other Middle East countries...
Brand Name : Glaricon
Molecule Type : Peptide
Upfront Cash : Undisclosed
December 07, 2021
Lead Product(s) : Insulin Glargine
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Sponsor : Biocon
Deal Size : Undisclosed
Deal Type : Agreement
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