Growth factors

Treatment of Anemia Among Hematology/Oncology Specialists Spans Diverse Patient Types, Many of Which Have Multiple Contributory Factors

Retrieved on: 
Tuesday, July 14, 2020

According to the Market Dynamix survey, anemia is a highly prevalent co-morbidity for many of the patients under their management.

Key Points: 
  • According to the Market Dynamix survey, anemia is a highly prevalent co-morbidity for many of the patients under their management.
  • Hematologists/oncologists frequently receive referrals for anemia work-ups from primary care physicians as well as certain specialists, including gastroenterologists, nephrologists, and OB-GYNs.
  • While hematologists/oncologists report that anemia is often linked to multiple factors, they estimate that chronic kidney disease (CKD) is a cause in about one-in-four of the anemia cases they see.
  • Two-thirds of respondents agree that patients would prefer an oral anemia treatment over agents that are administered subcutaneously like the ESAs.

European Commission Approves Reblozyl (luspatercept) for the Treatment of Transfusion-Dependent Anemia in Adult Patients with Myelodysplastic Syndromes or Beta Thalassemia

Retrieved on: 
Friday, June 26, 2020

The European Commissions approval of Reblozyl provides eligible adult patients with beta thalassemia a new, much needed treatment option for their anemia, and with it, the possibility of becoming less dependent on red blood cell transfusions.

Key Points: 
  • The European Commissions approval of Reblozyl provides eligible adult patients with beta thalassemia a new, much needed treatment option for their anemia, and with it, the possibility of becoming less dependent on red blood cell transfusions.
  • Reblozyl is the first and only erythroid maturation agent approved in the European Union, representing a new class of therapy for eligible patients.
  • Grade 3 or 4 TEAEs were reported in 42.5% of patients who received Reblozyl and 44.7% of patients who received placebo.
  • In adult patients with beta thalassemia, thromboembolic events (TEE) were reported in 8/223 (3.6%) REBLOZYL-treated patients.

FDA Approves First Therapy for Rare Disease that Causes Low Phosphate Blood Levels, Bone Softening

Retrieved on: 
Thursday, June 18, 2020

The tumors associated with TIO release a peptide hormone-like substance known as fibroblast growth factor 23 (FGF23) that lowers phosphate levels.

Key Points: 
  • The tumors associated with TIO release a peptide hormone-like substance known as fibroblast growth factor 23 (FGF23) that lowers phosphate levels.
  • "Treatment for TIO focuses on identifying and removing the tumor that causes the disease.
  • FGF23 regulates levels of phosphate, an electrolyte that plays important roles in bone maintenance, energy production by cells and nerve function.
  • When there is not enough phosphate in the body, bones begin to soften and weaken, causing osteomalacia (marked softening of bones).

FibroGen Announces New Roxadustat Data Presented at 2020 ERA-EDTA Virtual Congress

Retrieved on: 
Monday, June 8, 2020

These data were presented in virtual oral sessions of the 57th European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Virtual Congress, taking place June 6 - 9, 2020.

Key Points: 
  • These data were presented in virtual oral sessions of the 57th European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Virtual Congress, taking place June 6 - 9, 2020.
  • Regarding safety, the overall incidence of treatment-emergent adverse events was comparable between roxadustat and darbepoetin alfa (91.6% and 92.5%, respectively).
  • The studies presented at the ERA-EDTA Virtual Congress 2020 reinforce our commitment to turning innovative science into valued therapeutic medicines for patients.
  • Ophthalmological effects of roxadustat from a Phase 3, randomized, double-blind, active-comparator study in Japanese patients on dialysis converted from ESA therapy (Study 1517-CL-307) 2 were also presented at the ERA-EDTA Virtual Congress 2020.

FDA Accepts for Review Fresenius Kabi’s BLA Submission for Pegfilgrastim Biosimilar

Retrieved on: 
Wednesday, May 27, 2020

This is Fresenius Kabis first U.S. biosimilar regulatory submission.

Key Points: 
  • This is Fresenius Kabis first U.S. biosimilar regulatory submission.
  • Pegfilgrastim is used to reduce the incidence of infection associated with febrile neutropenia, a serious side effect of chemotherapy.
  • The acceptance of Fresenius Kabis submission of pegfilgrastim marks a key milestone as we seek approval for our first biosimilar in the United States, said John Ducker, president and CEO of Fresenius Kabi USA.
  • Fresenius Kabis BLA submission for its pegfilgrastim biosimilar candidate includes analytical, pharmacokinetic, pharmacodynamic, safety and immunogenicity data.

FibroGen to Present at Upcoming Investor Conferences

Retrieved on: 
Wednesday, May 27, 2020

A replay will be available for approximately 30 days.

Key Points: 
  • A replay will be available for approximately 30 days.
  • FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing and commercializing a pipeline of first-in-class therapeutics.
  • The company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines to treat unmet needs.
  • Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia.

Placenta Growth Factor Pipeline Review, H1 2020: Companies Involved in Therapeutics Development - ResearchAndMarkets.com

Retrieved on: 
Thursday, May 21, 2020

The "Placenta Growth Factor - Pipeline Review, H1 2020" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Placenta Growth Factor - Pipeline Review, H1 2020" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • This latest report provides comprehensive information on the Placenta Growth Factor (Vascular Endothelial Growth Factor Related Protein or PGF) targeted therapeutics, complete with analysis by indications, stage of development, mechanism of action (MoA), route of administration (RoA) and molecule type.
  • Placental growth factor (PGF) is a member of the VEGF (vascular endothelial growth factor).
  • This report also reviews key players involved in Placenta Growth Factor (Vascular Endothelial Growth Factor Related Protein or PGF) targeted therapeutics development with respective active and dormant or discontinued projects.

European Medicines Agency Accepts Astellas' Marketing Authorization Application for Roxadustat

Retrieved on: 
Thursday, May 21, 2020

As a HIF-PH inhibitor, roxadustat activates a response that occurs naturally when the body responds to reduced oxygen levels in the blood.

Key Points: 
  • As a HIF-PH inhibitor, roxadustat activates a response that occurs naturally when the body responds to reduced oxygen levels in the blood.
  • Roxadustat is approved and launched for the treatment of anemia associated with CKD in Japan in DD patients and in China in both DD and NDD patients.
  • A supplemental New Drug Application (sNDA) has been submitted to Japan's Pharmaceuticals and Medical Devices Agency for NDD patients and a New Drug Application (NDA) has been submitted in the US in both DD and NDD patients.
  • Roxadustat in the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients, Not on Dialysis, in Comparison to Darbepoetin Alfa (Dolomites).

Global TGF Beta Receptor Type 1 Pipeline Insights, 2020: Therapeutics Development & Assessment, Companies Involved, Drug Profiles, Dormant Products, Discontinued Products

Retrieved on: 
Thursday, April 2, 2020

DUBLIN, April 2, 2020 /PRNewswire/ -- The "TGF Beta Receptor Type 1 - Pipeline Review, H1 2020" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, April 2, 2020 /PRNewswire/ -- The "TGF Beta Receptor Type 1 - Pipeline Review, H1 2020" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • TGF Beta Receptor Type 1 pipeline Target constitutes close to 17 molecules.
  • This report outlays comprehensive information on the TGF Beta Receptor Type 1 targeted therapeutics, complete with analysis by indications, stage of development, mechanism of action (MoA), route of administration (RoA) and molecule type.
  • Furthermore, this report also reviews key players involved in TGF Beta Receptor Type 1 targeted therapeutics development with respective active and dormant or discontinued projects.

I-Mab Submits IND Application to Initiate Study of TJM2 for Treatment of Cytokine Storm Associated with Severe COVID-19 in South Korea

Retrieved on: 
Monday, March 30, 2020

The IND submission follows the announcement on March 13, 2020 of a similar program initiated by I-Mab in the U.S.

Key Points: 
  • The IND submission follows the announcement on March 13, 2020 of a similar program initiated by I-Mab in the U.S.
  • The proposed clinical trial in South Korea is a single-arm, open-label pilot study that will evaluate the effects of TJM2 on reducing cytokine levels, including GM-CSF, in patients with severe COVID-19 disease.
  • The Company has successfully completed a Phase I single ascending dose study of TJM2 in the United States (NCT03794180), in which TJM2 exhibited favorable safety, tolerability, PK/PD, and immunogenicity profiles.
  • TJM2 also received IND clearance from Chinas National Medical Products Administration for a multiple-dose Phase 1b study in patients with rheumatoid arthritis (RA).