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FDA use of Real-World Evidence in Regulatory Decision Making
23 Sep 2025 03:56 GMT
… severe hypocalcemia). FDA Drug Safety Communication: FDA adds Boxed … Pharmaceuticals, Inc
Medicare claims data
Retrospective cohort study
In FDA … trial used to approve Pradaxa. FDA … Dabigatran)
Epogen, Procrit, Aranesp (Erythropoietin stimulating agents …
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<![CDATA[Oncologists Choose Top Goals and Therapies for Treating MDS]]>
25 Sep 2025 19:03 GMT
… trial was a frontline trial of luspatercept vs epoetin … treatment decisions. The starting treatment dose per the FDA … have been on the medication long enough.
Conclusions … www.fda.gov/drugs/;resources-information-approved-drugs/fda-approves- …
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Eye on Pharma: Europe and MENA Region See Expanding Biosimilar Pipelines
25 Sep 2025 11:46 GMT
… the reference product during both treatment and observation periods. Experts … European Medicines Agency approval to begin a phase 3 trial of … Europe, complementing its teriparatide, bevacizumab, epoetin, adalimumab, tocilizumab, ustekinumab, aflibercept, …
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PSG Report: Humira Biosimilars Ease Specialty Drug Claim Costs
13 Aug 2025 03:43 GMT
… Trend report published by Pharmaceutical Strategies Group (PSG).
… Tufts Medical Center and leads the Specialty Drug Evidence … for Lucentis, Epogen/Procrit, and Remicade biosimilars.
But … for the targeted oncology treatment Herceptin (trastuzumab) had …
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Health Minister Halts Export of Vital Medicinal Product
14 Aug 2025 09:16 GMT
… and their access to uninterrupted treatment.
The ban will be in … brand name for Erythropoietin (Epoetin beta).
The medicine is an injectable solution …
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Identification and Validation of Hub Genes in Hidradenitis Suppurativa
24 Sep 2025 16:07 GMT
… The following drugs are not used in HS treatment based on … use of this drug may induce HS),89 epoetin alfa, busulfan, … the drug-gene interaction database for precision medicine and drug discovery platforms … Jun/MMPs. Acta pharmaceutica. 2024;74(3):461–478 …
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Luspatercept’s Benefit in MDS: Dr Garcia-Manero on COMMANDS Trial
07 Jul 2025 14:46 GMT
… a major shift in the treatment approach for erythropoiesis-stimulating … a phase 3 trial comparing luspatercept vs epoetin alfa. Luspatercept is … not measure this in clinical trials, so we have to … And they are great drugs. These drugs really help our patients …
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COMMANDS and ELEMENT-MDS Trials: Long-Term Analysis, Survival, Duration of Response, and Hemoglobin Levels
24 Jun 2025 17:22 GMT
… a phase 3 trial comparing luspatercept with epoetin alfa in … escalation or standard-dose epoetin, with treatment continuing until disease … . The ongoing ELEMENT-MDS trial, also highlighted briefly, is … the same agents. This trial aims to determine whether …
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Self-Administered Subcutaneous Isatuximab May Ease Multiple Myeloma Treatment Burden: Xavier Leleu, MD, PhD
26 Jun 2025 01:29 GMT
… of the phase 3 IRAKLIA trial (NCT05405166), which Leleu … patients. The future of the treatment [of] cancer, when a … drug, like G-CSF [granulocyte colony-stimulating factor], like EPO [epoetin … subcutaneous formulation manual push drugs that we inject into …
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Real-World Treatment Patterns, Clinical Outcomes, and Costs in Patients with Higher-Risk Myelodysplastic Syndromes Across France, Germany, and the United Kingdom
24 Jun 2025 14:26 GMT
… deferasirox, deferiprone, darbepoetin, epoetin, granulocyte colony-stimulating factor … treatment costs, while the first-line drug … compared with clinical trials. It is also … Medicines Corporation; speakers’ bureau for Astellas Pharma, Jazz Pharmaceuticals …