Erythropoietin

Akebia Receives FDA Approval of Vafseo® (vadadustat) Tablets for the Treatment of Anemia due to Chronic Kidney Disease in Adult Patients on Dialysis

Retrieved on: 
Thursday, March 28, 2024

CAMBRIDGE, Mass., March 27, 2024 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the U.S. Food and Drug Administration (FDA) has approved Vafseo® (vadadustat) Tablets for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Vafseo is a once-daily oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin to manage anemia. Vafseo is now approved in 37 countries.

Key Points: 
  • "At Akebia we are committed to kidney patients, a dedication that has driven our team to achieve this milestone.
  • We believe this commitment uniquely positions the company to execute a successful launch designed to drive toward a potential new oral standard of care for dialysis patients."
  • Approximately 500,000 adult patients in the U.S. on dialysis suffer from anemia due to CKD1, which may be associated with many adverse clinical outcomes.
  • Today, most CKD patients are treated for anemia with injectable erythropoiesis-stimulating agents mostly administered at dialysis centers.

Juvena Therapeutics Receives FDA Orphan Drug Designation for JUV-161 for the Treatment of Myotonic Dystrophy Type 1

Retrieved on: 
Tuesday, January 23, 2024

Juvena Therapeutics , a biotechnology company unlocking the potential of stem cell-secreted proteins to treat muscle and metabolic diseases including muscular dystrophies and obesity, today announced the U.S. Food and Drug Administration (FDA) granted Orphan Drug designation to the company’s flagship candidate, JUV-161.

Key Points: 
  • Juvena Therapeutics , a biotechnology company unlocking the potential of stem cell-secreted proteins to treat muscle and metabolic diseases including muscular dystrophies and obesity, today announced the U.S. Food and Drug Administration (FDA) granted Orphan Drug designation to the company’s flagship candidate, JUV-161.
  • JUV-161 is an investigational therapeutic for the treatment of Myotonic Dystrophy Type 1 (DM1), a rare, multi-systemic, autosomal dominant inherited disease and the most common form of adult muscular dystrophy.
  • “People living with DM1 deserve safe, effective, and rejuvenating treatments that can repair and restore tissue health to improve muscle function and metabolism,” said Dr. Hanadie Yousef, Co-Founder and CEO of Juvena Therapeutics.
  • Additionally, Juvena has identified multiple secreted protein hits that induce disease-modifying effects across several metabolic organs and therapeutic areas.

Human medicines European public assessment report (EPAR): Mircera, methoxy polyethylene glycol-epoetin beta, Date of authorisation: 20/07/2007, Revision: 30, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Mircera, methoxy polyethylene glycol-epoetin beta, Date of authorisation: 20/07/2007, Revision: 30, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Mircera, methoxy polyethylene glycol-epoetin beta, Date of authorisation: 20/07/2007, Revision: 30, Status: Authorised

Human medicines European public assessment report (EPAR): Jesduvroq, daprodustat, Status: Withdrawn application

Retrieved on: 
Tuesday, January 2, 2024

Jesduvroq contains the active substance daprodustat and was to be available as tablets to be taken by mouth.

Key Points: 
  • Jesduvroq contains the active substance daprodustat and was to be available as tablets to be taken by mouth.
  • Patients with chronic kidney disease may not produce enough erythropoietin, a hormone that stimulates the production of red blood cells.
  • The evaluation had finished and the European Medicines Agency had recommended approving the marketing authorisation.
  • The company withdrew the application before the European Commission had issued a decision on the Agency’s recommendation.

Keros Therapeutics Presents Clinical Data from its KER-050 Program at the 65th American Society of Hematology Annual Meeting and Exposition

Retrieved on: 
Monday, December 11, 2023

“Additionally, we are encouraged by the preliminary data from the lowest three dose cohorts from our ongoing Phase 2 clinical trial in MF.

Key Points: 
  • “Additionally, we are encouraged by the preliminary data from the lowest three dose cohorts from our ongoing Phase 2 clinical trial in MF.
  • Data for hematological response and markers of hematopoiesis were presented from exploratory analyses of these mITT24 patients.
  • All data presented from this trial is as of the data cut-off date.
  • 13 of those 18 patients (72.2%) achieved TI for at least 24 weeks over the first 48 weeks of treatment.

Global Erythropoietin (EPO) Drugs Market Research Report 2023-2031: Biosimilars and Patent Expirations Drive Transformation in the EPO Landscape - ResearchAndMarkets.com

Retrieved on: 
Thursday, September 7, 2023

The "Global Erythropoietin Drugs Market Report and Forecast 2023-2031" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Erythropoietin Drugs Market Report and Forecast 2023-2031" report has been added to ResearchAndMarkets.com's offering.
  • The Erythropoietin (EPO) drugs market is a vital segment of the pharmaceutical industry that focuses on the development and distribution of medications aimed at stimulating red blood cell production.
  • In summary, the EPO drugs market is driven by factors such as the rising prevalence of chronic kidney disease and the increasing use of EPO drugs in oncology.
  • Additionally, the expiration of patents for some originator EPO drugs has further contributed to market growth
    The major companies in the market are as follows:

Pharmaceuticals Top Trending Markets - By The Business Research Company

Retrieved on: 
Monday, September 11, 2023

LONDON, Sept. 11, 2023 /PRNewswire/ -- As per The Business Research Company's analysis, the pharmaceuticals market is poised for substantial growth in the coming years, with projections indicating a remarkable trajectory. It is anticipated that the market will surge to $2,050 billion by 2025 and further escalate to a staggering $3,206 billion by the year 2030. This dynamic expansion is attributed to various factors, including advancements in healthcare technologies, increasing global healthcare expenditures, and the growing prevalence of chronic diseases, all of which drive demand for pharmaceutical products and services.

Key Points: 
  • In this thriving pharmaceutical landscape, business intelligence and market insights play a pivotal role in guiding companies towards informed decision-making.
  • Reports from The Business Research Company (TBRC) offer invaluable assistance to businesses within the pharmaceuticals industry.
  • Interested to know more about The Business Research Company?
  • The Business Research Company has published over 6500+ detailed industry reports, spanning over 3000+ market segments and 60 geographies.

Pharmaceuticals Top Trending Markets - By The Business Research Company

Retrieved on: 
Monday, September 11, 2023

LONDON, Sept. 11, 2023 /PRNewswire/ -- As per The Business Research Company's analysis, the pharmaceuticals market is poised for substantial growth in the coming years, with projections indicating a remarkable trajectory. It is anticipated that the market will surge to $2,050 billion by 2025 and further escalate to a staggering $3,206 billion by the year 2030. This dynamic expansion is attributed to various factors, including advancements in healthcare technologies, increasing global healthcare expenditures, and the growing prevalence of chronic diseases, all of which drive demand for pharmaceutical products and services.

Key Points: 
  • In this thriving pharmaceutical landscape, business intelligence and market insights play a pivotal role in guiding companies towards informed decision-making.
  • Reports from The Business Research Company (TBRC) offer invaluable assistance to businesses within the pharmaceuticals industry.
  • Interested to know more about The Business Research Company?
  • The Business Research Company has published over 6500+ detailed industry reports, spanning over 3000+ market segments and 60 geographies.

Pharmaceuticals Top Trending Markets - By The Business Research Company

Retrieved on: 
Friday, September 8, 2023

LONDON, Sept. 8, 2023 /PRNewswire/ -- As per The Business Research Company's analysis, the pharmaceuticals market is poised for substantial growth in the coming years, with projections indicating a remarkable trajectory. It is anticipated that the market will surge to $2,050 billion by 2025 and further escalate to a staggering $3,206 billion by the year 2030. This dynamic expansion is attributed to various factors, including advancements in healthcare technologies, increasing global healthcare expenditures, and the growing prevalence of chronic diseases, all of which drive demand for pharmaceutical products and services.

Key Points: 
  • In this thriving pharmaceutical landscape, business intelligence and market insights play a pivotal role in guiding companies towards informed decision-making.
  • Reports from The Business Research Company (TBRC) offer invaluable assistance to businesses within the pharmaceuticals industry.
  • Interested to know more about The Business Research Company?
  • The Business Research Company has published over 6500+ detailed industry reports, spanning over 3000+ market segments and 60 geographies.

The Enhanced Games: letting athletes use drugs could lead to worse problems than cheating

Retrieved on: 
Tuesday, July 11, 2023

The Enhanced Games seeks to answer these questions by removing all restrictions on doping.

Key Points: 
  • The Enhanced Games seeks to answer these questions by removing all restrictions on doping.
  • In lifting the ban on performance-enhancing drugs, the Enhanced Games challenges a core tenet of modern sports ethics – that sport should be doping-free.
  • However, it is far from clear that enhanced sport will open new horizons of sports performance, support athlete autonomy, or promote fair competition.

Peak performance?

    • Anti-doping rules limit the substances that athletes can use to reach peak performance.
    • Anabolic steroids can help weightlifters to lift heavier and erythropoietin can help distance runners to run faster.
    • So the prohibition of these substances appears to place a ceiling on the pursuit of sporting achievement.
    • Furthermore, sports are designed to test a specific cluster of skills and capacities, including physical, psychological, tactical and technical abilities.

Time to abandon a failed system?

    • However, lifting the doping ban would grant further competitive advantage to athletes who represent economic superpowers such as the US and China.
    • These governments could invest huge sums into drug research and development for the benefit of their athletes.
    • The Enhanced Games will increase the risk to athletes’ health, render competition even more unfair and threaten to undermine the fundamental purpose of sport.