HDV

Glympse Appoints Tram Tran, M.D., as Chief Medical Officer

Retrieved on: 
수요일, 9월 8, 2021

CAMBRIDGE, Mass., Sept. 8, 2021 /PRNewswire/ --Glympse, a biotechnology company developing innovative technology to improve disease diagnosis and monitoring, today announced the appointment of Tram Tran, M.D., to the newly created role of Chief Medical Officer.

Key Points: 
  • CAMBRIDGE, Mass., Sept. 8, 2021 /PRNewswire/ --Glympse, a biotechnology company developing innovative technology to improve disease diagnosis and monitoring, today announced the appointment of Tram Tran, M.D., to the newly created role of Chief Medical Officer.
  • Dr. Tran plays a critical role within the executive team, overseeing the company's clinical development programs during a period of growth.
  • "The addition of Tram brings significant medical and biopharmaceutical expertise to our leadership team," said Caroline Loew, Ph.D., Chief Executive Officer of Glympse.
  • Using a proprietary machine learning algorithm, the Glympse biosensor protease activity assay data is used to generate real-time information about the disease.

Eiger Announces FDA Breakthrough Therapy Designation for Avexitide for Treatment of Congenital Hyperinsulinism

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목요일, 8월 5, 2021

Eiger's application was supported by data from three completed Phase 2 studies in 39 neonates, children and adolescents with congenital hyperinsulinism.

Key Points: 
  • Eiger's application was supported by data from three completed Phase 2 studies in 39 neonates, children and adolescents with congenital hyperinsulinism.
  • "Avexitide represents a promising, targeted approach for the treatment of congenital hyperinsulinism, an urgent, unmet medical need with no approved therapy," said Colleen Craig, MD, Vice President of Metabolic Diseases at Eiger.
  • Avexitide has been granted Breakthrough Therapy Designation by the FDA for the treatment of congenital hyperinsulism, Orphan Drug Designation by the FDA for the treatment of hyperinsulinemic hypoglycemia (which includes congenital hyperinsulinism), Orphan Drug Designation by the EMA for the treatment of congenital hyperinsulinism and Rare Pediatric Disease Designation by the FDA.
  • Avexitide has been granted Breakthrough Therapy Designation by the FDA, as well as Orphan Drug Designation by the FDA for the treatment of hyperinsulinemic hypoglycemia and Orphan Drug Designation by the EMA for the treatment of non-insulinoma pancreatogenous hypoglycemia syndrome (NIPHS).

Global Hepatitis D Market Insight, Epidemiology and Market Forecasts to 2030 - ResearchAndMarkets.com

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월요일, 3월 8, 2021

The "Hepatitis D - Market Insight, Epidemiology and Market Forecast - 2030" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Hepatitis D - Market Insight, Epidemiology and Market Forecast - 2030" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • The HDV market report provides current treatment practices, emerging drugs, HDV market share of the individual therapies, current and forecasted HDV market size from 2017 to 2030.
  • The report provides an edge while developing business strategies, by understanding trends shaping and driving the global HDV market.
  • What would be the HDV market growth till 2030 and what will be the resultant market size in the year 2030?

Global Hepatitis D Epidemiology Forecast Report 2017-2030 - ResearchAndMarkets.com

Retrieved on: 
목요일, 2월 11, 2021

The "Hepatitis D - Epidemiology Forecast to 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Hepatitis D - Epidemiology Forecast to 2030" report has been added to ResearchAndMarkets.com's offering.
  • The HDV epidemiology division provides insights about the historical and current HDV patient pool and forecasted trends for every seven major countries.
  • This part of The report also provides the diagnosed patient pool and their trends along with assumptions undertaken.
  • The disease epidemiology covered in the report provides historical as well as forecasted HDV epidemiology [segmented as Total Diagnosed Prevalent Cases of HDV, Gender-specific Diagnosed Prevalent Cases of HDV, Age-specific Diagnosed Prevalent Cases of HDV, Diagnosed Prevalent Cases of HDV by Impact on Liver, and Treated cases of HDV] in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2017 to 2030.

Diasome to Present Data from Phase 2 OPTI-1 Clinical Trial at the 80th Annual American Diabetes Association Virtual Scientific Sessions

Retrieved on: 
목요일, 6월 4, 2020

Posters will be publicly available for viewing on the ADA ePoster archive site after September 10, 2020.

Key Points: 
  • Posters will be publicly available for viewing on the ADA ePoster archive site after September 10, 2020.
  • Only 20-50 nanometers in size, these two-layered microscopic discs are designed to bring insulin to receptors highly expressed by liver cells.
  • Liquid HDV can be mixed with any commercially available insulin prior to administration and is compatible with any insulin delivery system.
  • HDV technology is a Phase 3-ready asset designed to improve the safety and efficacy of all insulins.

Diasome Announces Positive Results from Phase 2 OPTI-1 Study of Hepatocyte Directed Vesicle Technology in Type 1 Diabetes

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화요일, 2월 18, 2020

CLEVELAND, Feb. 18, 2020 (GLOBE NEWSWIRE) -- DiasomePharmaceuticals, Inc. , a company developing hepatocyte directed vesicle (HDV) technology that can be added to any commercially available insulin to optimize treatment for people living with diabetes, today announced positive results from its Phase 2 OPTI-1 study of injectable hepatocyte directed vesicle (HDV) added to mealtime insulin in people with type 1 diabetes (T1D).

Key Points: 
  • CLEVELAND, Feb. 18, 2020 (GLOBE NEWSWIRE) -- DiasomePharmaceuticals, Inc. , a company developing hepatocyte directed vesicle (HDV) technology that can be added to any commercially available insulin to optimize treatment for people living with diabetes, today announced positive results from its Phase 2 OPTI-1 study of injectable hepatocyte directed vesicle (HDV) added to mealtime insulin in people with type 1 diabetes (T1D).
  • The 24-week, open-label, multiple dose trial is designed to assess the safety, tolerability and efficacy of hepatocyte directed vesicle (HDV) technology when added to rapid-acting mealtime insulin.
  • Diasomes hepatocyte directed vesicle (HDV) technology is the only pharmaceutical insulin additive being developed to prevent hypoglycemia by restoring normal liver physiology in patients with diabetes.
  • HDV technology is a Phase 3-ready asset designed to improve the safety and efficacy of all insulins.

Eiger Announces 36% Durable Virologic Response at 24 Weeks Post-Treatment with Peginterferon Lambda in Phase 2 LIMT HDV Study at The International Liver Congress™ 2019

Retrieved on: 
목요일, 4월 11, 2019

LIMT HDV enrolled a total of 33 patients with chronic HDV, randomized to monotherapy Lambda 180 g (N=14) or Lambda 120 g (N=19), weekly subcutaneous injections for 48 weeks with 24 weeks of follow-up.

Key Points: 
  • LIMT HDV enrolled a total of 33 patients with chronic HDV, randomized to monotherapy Lambda 180 g (N=14) or Lambda 120 g (N=19), weekly subcutaneous injections for 48 weeks with 24 weeks of follow-up.
  • Objectives of the Phase 2 LIMT HDV study were to demonstrate comparable activity and improved tolerability of peginterferon lambda (Lambda) versus historical peginterferon alfa in HDV-infected patients.
  • "The durable virologic response observed 24 weeks post-treatment with Lambda may be a meaningful endpoint for discussions with regulatory agencies," said David Apelian, COO and Executive Medical Officer at Eiger.
  • LIMT HDV is a 1:1 randomized, open-label study of Lambda 120 or 180 g subcutaneous injections administered weekly for 48 weeks in 33 patients with chronic HDV.