Recombinant proteins

Viatris Inc. and Biocon Biologics Receive Historic Approval for First Interchangeable Biosimilar Semglee® (insulin glargine-yfgn injection) for the Treatment of Diabetes

Thursday, July 29, 2021 - 4:29am

The company is eligible to have exclusivity for 12 months before the FDA can approve another biosimilar interchangeable to Lantus.

Key Points: 
  • The company is eligible to have exclusivity for 12 months before the FDA can approve another biosimilar interchangeable to Lantus.
  • Semglee is indicated to control high blood sugar in adults with Type 2 diabetes and adults and pediatric patients with Type 1 diabetes.
  • Biocon Biologics, Executive Chairperson, Kiran Mazumdar-Shaw said: "We are extremely proud to be the first to obtain approval of an interchangeable Biosimilar product in the U.S.
  • This will allow pharmacy level substitution and thereby provide convenient and affordable access to Semglee, a quality Biosimilar Insulin Glargine."

FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes

Wednesday, July 28, 2021 - 10:20pm

Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with (can be substituted for), its reference product Lantus (insulin glargine), a long-acting insulin analog.

Key Points: 
  • Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with (can be substituted for), its reference product Lantus (insulin glargine), a long-acting insulin analog.
  • Semglee (insulin glargine-yfgn) is the first interchangeable biosimilar product approved in the U.S. for the treatment of diabetes.
  • "This is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce health care costs," said Acting FDA Commissioner Janet Woodcock, M.D.
  • The FDA released new materials for health care providers to enhance understanding about biosimilar and interchangeable biosimilar products, including a fact sheet about interchangeable biosimilar products.

$11.4 Billion Global Rapid Acting Insulin Market (2021 to 2027) - Industry Analysis Report and Forecasts - ResearchAndMarkets.com

Thursday, July 22, 2021 - 5:01pm

A rapid-acting insulin is considered as an insulin analog created to mimic meal-induced insulin secretion.

Key Points: 
  • A rapid-acting insulin is considered as an insulin analog created to mimic meal-induced insulin secretion.
  • By performing rapid-acting insulin opportunity analysis assessment, higher availability of constant glucose tracking will assist in complex analysis of clinic rapid insulin action which was not earlier feasible.
  • Based on Product Type, the market is segmented into Insulin Lispro, Insulin Aspart and Insulin Glulisine.
  • There is a growing case of diabetes and an increasing geriatric population, which is boosting the regional rapid-acting insulin market.

New Data for Genentech’s Hemlibra (emicizumab-kxwh) Reinforce Safety Profile in People With Hemophilia A

Monday, July 19, 2021 - 6:00am

The data were presented at the virtual International Society on Thrombosis and Haemostasis (ISTH) 2021 Congress, July 17-21.

Key Points: 
  • The data were presented at the virtual International Society on Thrombosis and Haemostasis (ISTH) 2021 Congress, July 17-21.
  • These results provide further confidence in Hemlibras favorable safety profile in people with hemophilia A with factor VIII inhibitors, who have historically faced significant treatment challenges.
  • Nearly one in three people with severe hemophilia A develop factor VIII inhibitors, antibodies that bind to and block the efficacy of replacement factor VIII.
  • Hemlibra has been approved in more than 100 countries worldwide for the treatment of people with hemophilia A with factor VIII inhibitors.

TempraMed's VIVI Cap 1 is changing the way people who inject insulin live their lives

Friday, July 16, 2021 - 2:00pm

TempraMed's recently launched VIVI Cap 1 is an easy-to-use reusable insulin pen cap that keeps diabetes insulin at a safe temperature 24/7 365 days a year, for years on end without need for any user intervention.

Key Points: 
  • TempraMed's recently launched VIVI Cap 1 is an easy-to-use reusable insulin pen cap that keeps diabetes insulin at a safe temperature 24/7 365 days a year, for years on end without need for any user intervention.
  • From the point of manufacturing up until it is used, insulin needs to be kept between 36 to 46F.
  • During use, insulin does not have to be refrigerated but it should stay below 86F and should not freeze.
  • Thus, reducing the risk of using damaged insulin and wasting money from discarded insulin that might have been compromised.

Insights on the Human Insulin Global Market to 2026 - by Product Type, Distribution Type, Disease Type and Region - ResearchAndMarkets.com

Tuesday, July 13, 2021 - 4:41pm

The "Human Insulin Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2021-2026" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Human Insulin Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2021-2026" report has been added to ResearchAndMarkets.com's offering.
  • The global human insulin market exhibited moderate growth during 2015-2020.
  • Looking forward, the publisher expects the market to grow at a CAGR of around 5% during the forecast period (2021-2026).
  • Human insulin (HI) is a form of synthetic insulin that is synthesized in laboratories for pharmaceutical use.

Sigilon Therapeutics Announces Clinical Hold on SIG-001 Phase 1/2 Study in Hemophilia A

Friday, July 9, 2021 - 12:30pm

The clinical hold was initiated following the Companys submission of a serious adverse event (SAE) and temporary enrollment halt to the FDA and other regulatory agencies.

Key Points: 
  • The clinical hold was initiated following the Companys submission of a serious adverse event (SAE) and temporary enrollment halt to the FDA and other regulatory agencies.
  • The third patient, who received the highest dose of study drug, developed inhibitors to Factor VIII (FVIII) a well-known complication of FVIII therapy.
  • All three patients enrolled in this study will continue to be followed per study protocol, while the company investigates the SAE.
  • Sigilon Therapeutics seeks to develop functional cures for chronic diseases through its Shielded Living Therapeutics platform.

Chemotherapy Induced Neutropenia (CIN) Market Insight, Epidemiology and Market Forecast Report 2021-2030 - ResearchAndMarkets.com

Wednesday, July 7, 2021 - 8:34am

The "Chemotherapy Induced Neutropenia (CIN) Market Insight, Epidemiology and Market Forecast - 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Chemotherapy Induced Neutropenia (CIN) Market Insight, Epidemiology and Market Forecast - 2030" report has been added to ResearchAndMarkets.com's offering.
  • This 'Chemotherapy Induced Neutropenia (CIN) Market Insights, Epidemiology, and Market Forecast-2030' report delivers an in-depth understanding of the CIN, historical and forecasted epidemiology as well as the CIN market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
  • United States contributes to the major share of the Chemotherapy Induced Neutropenia (CIN) market as compared to other 7MM countries.
  • The current market of Chemotherapy Induced Neutropenia (CIN) is mainly covered by Neulasta, Neupogen, and their biosimilars.

New Data on Phase 1 Proposed Biosimilar Gan & Lee Insulins Aspart (GL-ASP), Lispro (GL-LIS), and Glargine (GL-GLA) Presented at the American Diabetes Association's 81st Scientific Sessions

Friday, July 2, 2021 - 8:00am

The new data pertained to three proposed biosimilar Gan & Lee insulin analogs, insulin aspart (GL-ASP), insulin lispro (GL-LIS), and insulin glargine (GL-GLA), and were presented by the primary investigators from Profil, (Germany).

Key Points: 
  • The new data pertained to three proposed biosimilar Gan & Lee insulin analogs, insulin aspart (GL-ASP), insulin lispro (GL-LIS), and insulin glargine (GL-GLA), and were presented by the primary investigators from Profil, (Germany).
  • These data demonstrate pharmacokinetic and pharmacodynamic bioequivalence between each of the proposed biosimilar Gan & Lee insulins and their respective reference compounds.
  • In addition, the safety profiles were comparable between each of the three proposed biosimilar Gan & Lee insulins and their respective reference compounds1,2,3.
  • The data presented from the abstracts, are a major milestone in the biosimilar clinical development programs at Gan & Lee.

New Data on Phase 1 Proposed Biosimilar Gan & Lee Insulins Aspart (GL-ASP), Lispro (GL-LIS), and Glargine (GL-GLA) Presented at the American Diabetes Association's 81st Scientific Sessions

Friday, July 2, 2021 - 8:00am

The new data pertained to three proposed biosimilar Gan & Lee insulin analogs, insulin aspart (GL-ASP), insulin lispro (GL-LIS), and insulin glargine (GL-GLA), and were presented by the primary investigators from Profil, (Germany).

Key Points: 
  • The new data pertained to three proposed biosimilar Gan & Lee insulin analogs, insulin aspart (GL-ASP), insulin lispro (GL-LIS), and insulin glargine (GL-GLA), and were presented by the primary investigators from Profil, (Germany).
  • These data demonstrate pharmacokinetic and pharmacodynamic bioequivalence between each of the proposed biosimilar Gan & Lee insulins and their respective reference compounds.
  • In addition, the safety profiles were comparable between each of the three proposed biosimilar Gan & Lee insulins and their respective reference compounds1,2,3.
  • The data presented from the abstracts, are a major milestone in the biosimilar clinical development programs at Gan & Lee.