Peptide hormones

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.

Trevena Announces First Patient Enrolled in NIH-Funded ACTIV-4 Host Tissue Trial of TRV027 for COVID-19

Monday, July 26, 2021 - 12:00pm

I am excited that patients are now being enrolled in this study and that TRV027 is the one of the first active treatment arms available for patient randomization.

Key Points: 
  • I am excited that patients are now being enrolled in this study and that TRV027 is the one of the first active treatment arms available for patient randomization.
  • The trial, known as ACTIV-4 Host Tissue, is testing four investigational agents that combat dysregulation of the renin-angiotensin-aldosterone system (RAAS) and the immune system caused by a COVID-19 infection.
  • The trial is enrolling approximately 1,600 patients at over 50 sites in the U.S. TRV027 is part of the initial trial launch, and additional study arms will be added to the trial over time.
  • I am very pleased that we have enrolled our first patient in the ACTIV-4 Host Tissue trial, and I look forward to investigating the potential of TRV027 to modulate the RAAS and improve outcomes for patients hospitalized with COVID-19.

BYDUREON BCise (exenatide extended-release) Approved in the US for the Treatment of Type 2 Diabetes in Pediatric Patients Ages 10 Years and Older

Friday, July 23, 2021 - 12:00pm

This is the first completed trial of a once-weekly GLP-1 RA in a pediatric population with T2D.

Key Points: 
  • This is the first completed trial of a once-weekly GLP-1 RA in a pediatric population with T2D.
  • Safety and effectiveness of exenatide extended-release have not been established in pediatric patients less than 10 years of age.
  • If this occurs, patients should discontinue BYDUREON BCise and promptly seek medical advice
    Drug-induced, immune-mediated thrombocytopenia and associated bleeding has been reported with exenatide.
  • Based in Cambridge, UK, AstraZeneca operates in over 100 countries, and its innovative medicines are used by millions of patients worldwide.

Dr. Gerald Shulman Joins Levels as Advisor

Thursday, July 22, 2021 - 6:13pm

Levels , the first biowearable system to give real-time biofeedback on nutrition and lifestyle, today announced that Dr. Gerald Shulman, MD-PhD, has joined the company as an Advisor .

Key Points: 
  • Levels , the first biowearable system to give real-time biofeedback on nutrition and lifestyle, today announced that Dr. Gerald Shulman, MD-PhD, has joined the company as an Advisor .
  • In this role, Dr. Shulman will advise on our strategy and collaborate with Levels on research to understand better the physiologic drivers of insulin resistance and other metabolic dysfunction.
  • View the full release here: https://www.businesswire.com/news/home/20210722005815/en/
    Dr. Gerald Shulman Joins Levels as Advisor (Photo: Business Wire)
    Dr. Shulman is the George R. Cowgill Professor of Medicine and Professor of Cellular and Molecular Physiology at Yale.
  • Levels is currently running a closed beta program focused on product development and has a waitlist of over 115,000 people.

$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.

Xeris Pharmaceuticals Enters Into an Exclusive License and Supply Agreement with Tetris Pharma Limited to Commercialize Ogluo® in Europe

Monday, July 19, 2021 - 1:00pm

Under the terms of the applicable agreements, Xeris will be responsible for product supply and Tetris will be responsible for the commercialization of Ogluo in the Territory.

Key Points: 
  • Under the terms of the applicable agreements, Xeris will be responsible for product supply and Tetris will be responsible for the commercialization of Ogluo in the Territory.
  • Gvoke is indicated for the treatment of severe hypoglycaemia in paediatric and adult patients with diabetes ages 2 years and above.
  • The United Kingdoms Medicines and Healthcare products Regulatory Agency (MHRA) approved Ogluo (glucagon) injection on April 29, 2021.
  • Ogluo is indicated for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus.

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.

Clarus Therapeutics Announces Comprehensive Settlement of Patent Litigation With Lipocine

Thursday, July 15, 2021 - 2:00pm

These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.

Key Points: 
  • These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
  • Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.
  • Safety and efficacy of JATENZO in males less than 18 years old have not been established.
  • Before initiating JATENZO, consider the patient's baseline cardiovascular risk and ensure blood pressure is adequately controlled.

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.