Epoetin alfa

European Commission Expands Approval of Bristol Myers Squibb’s Reblozyl® (luspatercept) to Include First-Line Treatment of Transfusion-Dependent Anemia in Adults with Lower-Risk Myelodysplastic Syndromes (LR-MDS)

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星期三, 四月 3, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Civil service commission, BMY, Safety, Patient, Transfusion-dependent anemia, Bristol Myers Squibb, European Commission, Anemia, MDS, Epoetin alfa, Pharmaceutical industry

Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has expanded approval of Reblozyl® (luspatercept) to include the first-line treatment of adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS).

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has expanded approval of Reblozyl® (luspatercept) to include the first-line treatment of adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS).
  • This approval of Reblozyl covers all EU member states.
  • Safety results were consistent with previous MDS studies and were in line with expected symptoms in this patient population.
  • Reblozyl is also approved in the United States and Japan for the first-line treatment of anemia associated with lower-risk MDS.

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

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星期二, 一月 2, 2024
Patient, Medical Subject Headings, Marketing, Erythropoietin, European Commission, Agency, ESA, Methoxy group, INN, Bone marrow, ATC, Polyethylene, Kidney disease, Hypertension, International, European, Disease, Darbepoetin alfa, Ageing, Blood, Language, Chronic kidney disease, Oxygen, European Medicines Agency, Select, Epoetin alfa, Committee, Iron, Safety, Anatomy, Medicine, Skin, Dialysis, IIA, CHMP, CKD, Medical device

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

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星期二, 一月 2, 2024
Patient, Medical Subject Headings, Marketing, Erythropoietin, European Commission, Agency, INN, ATC, EMA, International, Darbepoetin alfa, Blood, Mouth, Civil service commission, Clinical trial, Chronic kidney disease, Oxygen, European Medicines Agency, Kidney disease, Tablet, Review, Epoetin alfa, Safety, Anatomy, Medicine, Dialysis

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.

Bristol Myers Squibb Presents Primary Efficacy and Safety Analysis of the Phase 3 COMMANDS Trial of Reblozyl for Treatment of Anemia in Erythropoiesis Stimulating Agent-Naïve Patients with Lower-Risk Myelodysplastic Syndromes at ASH 2023

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星期六, 十二月 9, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Bristol Myers Squibb, NYSE, European Commission, University, ASH, HB, Civil service commission, Patient, ASCO, BMY, Merck, ESA, MDS, Myelodysplastic syndrome, Anemia, MD Anderson Cancer Center, Society, RBC, ITT, Epoetin alfa, Pharmaceutical industry, Dietary supplement

These data are being presented in an oral presentation at the 2023 American Society of Hematology (ASH) Annual Meeting, from December 9-12.

Key Points: 
  • These data are being presented in an oral presentation at the 2023 American Society of Hematology (ASH) Annual Meeting, from December 9-12.
  • Reblozyl is being developed and commercialized through a global collaboration with Merck as of November 2021.
  • At the time of the primary analysis (March 31, 2023), 363 patients were randomized 1:1 to Reblozyl and epoetin alfa.
  • Erythroid response (HI-E) increase of at least 8 weeks was achieved by 74.2% (n=135) of Reblozyl patients vs. 53% (n=96) of epoetin alfa patients (p

Darbepoetin Alfa (Aranesp) Global Market Research Report 2023 - ResearchAndMarkets.com

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星期一, 十月 23, 2023
Health, Pharmaceutical, FDA, Sale, Daprodustat, Ageing, National library, Anemia, Food, Epoetin alfa, Bone marrow, Prevalence, Conditional sentence, US Foods, Darbepoetin alfa, GSK plc, Cell, Chronic kidney disease, Growth, Dialysis, Chronic condition, Cancer, Patient, National Library of Medicine classification, Dietary supplement, Pharmaceutical industry

The "Darbepoetin Alfa (Aranesp) Global Market Report 2023" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Darbepoetin Alfa (Aranesp) Global Market Report 2023" report has been added to ResearchAndMarkets.com's offering.
  • The prevalence of chronic diseases is on the rise, and this trend is expected to drive the growth of the darbepoetin alfa market.
  • This substantial increase in the prevalence of chronic diseases is a significant driver of the darbepoetin alfa market.
  • Product innovation is a prominent trend in the darbepoetin alfa market, with major companies adopting new technologies to maintain their market positions.

U.S. FDA Approves Bristol Myers Squibb’s Reblozyl® (luspatercept-aamt) as First-Line Treatment of Anemia in Adults with Lower-Risk Myelodysplastic Syndromes (MDS) Who May Require Transfusions

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星期二, 八月 29, 2023
Biotechnology, General Health, FDA, Health, Pharmaceutical, Myelodysplastic syndrome, Epoetin alfa, Bristol Myers Squibb, RBC, European Hematology Association, ESA, Diarrhea, Hematology, Cell therapy, American Society of Clinical Oncology, Multimedia, BMY, MD Anderson Cancer Center, ASCO, MDS, Congress, Hypertension, Peripheral edema, HB, Phase 3, Patient, University, Anemia, Annual general meeting, EHA, Nausea, Periodic breathing, Merck, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, NYSE, Society, Food, Fatigue, Pharmaceutical industry, Medical device, Lancet

These results underscore Reblozyl’s ability to address chronic anemia earlier in the treatment journey in a broader range of patients.

Key Points: 
  • These results underscore Reblozyl’s ability to address chronic anemia earlier in the treatment journey in a broader range of patients.
  • HI-E increase of at least 8 weeks was achieved by 74.1% (n=109) of Reblozyl patients vs. 51.3% (n=79) of epoetin alfa patients (p
  • RBC-TI of at least 12 weeks was achieved by 66.7% (n=98) of Reblozyl patients vs. 46.1% (n=71) of epoetin alfa patients (p=0.0003).
  • Patients treated with Reblozyl demonstrated durable responses with nearly 2.5 years of median RBC-TI ≥12 weeks (126.6 weeks, week 1 to end of treatment).

Frost & Sullivan Awarded Duopharma Biotech with the 2022 Malaysian Company of the Year Award

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星期四, 七月 27, 2023
Anemia, Automotive Executive of the Year Award, Korea Muslim Federation, Diabetes, Health care, Policy, Cancer, KMF, Epoetin alfa, Oncology, Dialysis, Biotechnology, Frost, Hospital, Patient, Halal, SAN, Biosimilar, Generic drug, Pharmaceutical industry, ASEAN

SAN ANTONIO, July 27, 2023 /PRNewswire/ -- Frost & Sullivan recently researched the Malaysian biosimilars industry and, based on its findings, recognizes Duopharma Biotech Berhad (Duopharma Biotech) with the 2022 Malaysian Company of the Year Award. Duopharma Biotech delivers accessible and affordable healthcare to the Malaysian population by leveraging biosimilars, which are scientifically approved alternatives to drugs derived from biological sources.

Key Points: 
  • Duopharma Biotech is the first pharmaceutical company to offer biosimilar products in the Malaysian market.
  • SAN ANTONIO, July 27, 2023 /PRNewswire/ -- Frost & Sullivan recently researched the Malaysian biosimilars industry and, based on its findings, recognizes Duopharma Biotech Berhad (Duopharma Biotech) with the 2022 Malaysian Company of the Year Award .
  • Duopharma Biotech delivers accessible and affordable healthcare to the Malaysian population by leveraging biosimilars, which are scientifically approved alternatives to drugs derived from biological sources.
  • Each year, Frost & Sullivan presents a Company of the Year award to the organization demonstrating excellence in growth strategy and implementation in its field.

Frost & Sullivan Awarded Duopharma Biotech with the 2022 Malaysian Company of the Year Award

Retrieved on: 
星期四, 七月 27, 2023
Anemia, Automotive Executive of the Year Award, Korea Muslim Federation, Diabetes, Health care, Policy, Cancer, KMF, Epoetin alfa, Oncology, Dialysis, Biotechnology, Frost, Hospital, Patient, Halal, SAN, Biosimilar, Generic drug, Pharmaceutical industry, ASEAN

SAN ANTONIO, July 27, 2023 /PRNewswire/ -- Frost & Sullivan recently researched the Malaysian biosimilars industry and, based on its findings, recognizes Duopharma Biotech Berhad (Duopharma Biotech) with the 2022 Malaysian Company of the Year Award. Duopharma Biotech delivers accessible and affordable healthcare to the Malaysian population by leveraging biosimilars, which are scientifically approved alternatives to drugs derived from biological sources.

Key Points: 
  • Duopharma Biotech is the first pharmaceutical company to offer biosimilar products in the Malaysian market.
  • SAN ANTONIO, July 27, 2023 /PRNewswire/ -- Frost & Sullivan recently researched the Malaysian biosimilars industry and, based on its findings, recognizes Duopharma Biotech Berhad (Duopharma Biotech) with the 2022 Malaysian Company of the Year Award .
  • Duopharma Biotech delivers accessible and affordable healthcare to the Malaysian population by leveraging biosimilars, which are scientifically approved alternatives to drugs derived from biological sources.
  • Each year, Frost & Sullivan presents a Company of the Year award to the organization demonstrating excellence in growth strategy and implementation in its field.

FIBROGEN INVESTIGATION CONTINUED BY FORMER LOUISIANA ATTORNEY GENERAL: Kahn Swick & Foti, LLC Continues its Investigation of the Officers and Directors of FibroGen, Inc. - FGEN

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星期六, 七月 1, 2023
Epoetin alfa, Certification, Committee, KSF, Death, Food, Roxadustat

NEW ORLEANS, June 30, 2023 (GLOBE NEWSWIRE) -- Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC (“KSF”), announces that KSF continues its investigation into FibroGen, Inc. (NasdaqGS: FGEN).

Key Points: 
  • NEW ORLEANS, June 30, 2023 (GLOBE NEWSWIRE) -- Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC (“KSF”), announces that KSF continues its investigation into FibroGen, Inc. (NasdaqGS: FGEN).
  • The Company was subsequently sued in a securities class action lawsuit for failing to disclose material information, violating federal securities laws.
  • Recently, the Lead Plaintiffs in the case moved for certification of the class as the case continues to move forward.
  • KSF’s investigation is focusing on whether FibroGen’s officers and/or directors breached their fiduciary duties to the Company’s shareholders or otherwise violated state or federal laws.

FIBROGEN INVESTIGATION CONTINUED BY FORMER LOUISIANA ATTORNEY GENERAL: Kahn Swick & Foti, LLC Continues its Investigation of the Officers and Directors of FibroGen, Inc. - FGEN

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星期六, 六月 17, 2023
Epoetin alfa, Certification, Committee, KSF, Death, Food, Roxadustat

NEW ORLEANS, June 16, 2023 (GLOBE NEWSWIRE) -- Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC (“KSF”), announces that KSF continues its investigation into FibroGen, Inc. (NasdaqGS: FGEN).

Key Points: 
  • NEW ORLEANS, June 16, 2023 (GLOBE NEWSWIRE) -- Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC (“KSF”), announces that KSF continues its investigation into FibroGen, Inc. (NasdaqGS: FGEN).
  • The Company was subsequently sued in a securities class action lawsuit for failing to disclose material information, violating federal securities laws.
  • Recently, the Lead Plaintiffs in the case moved for certification of the class as the case continues to move forward.
  • KSF’s investigation is focusing on whether FibroGen’s officers and/or directors breached their fiduciary duties to the Company’s shareholders or otherwise violated state or federal laws.