In a significant development for cancer research, Kurome Therapeutics Inc. has announced the U.S. Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application for KME-0584, propelling the biotech firm into a Phase 1 clinical trial for patients with relapsed/refractory (R/R) Acute Myeloid Leukemia (AML) and high-risk (HR) Myelodysplastic Syndromes (MDS). Slated […]
Biopharmaceutical firm Gilead Sciences (Nasdaq: GILD) has announced the termination of its Phase 3 ENHANCE study in higher-risk myelodysplastic syndromes (MDS) due to a lack of promising results, according to a planned analysis. The safety data observed during the trial was found to align with the known profile of magrolimab, an investigational anti-CD47 immunotherapy drug […]
Indian pharma company Zydus Lifesciences Limited, previously known as Cadila Healthcare Limited has launched Lenalidomide Capsules, a generic of Revlimid, in the US market. The launch of Lenalidomide Capsules follows the final approvals for 5 mg, 10 mg, 15 mg and 25 mg strengths and tentative approvals for 2.5 mg and 20 mg strength from […]
Medexus Pharmaceuticals said that its strategic partner medac has resubmitted the new drug application (NDA) for treosulfan with the US Food and Drug Administration (FDA). Treosulfan is part of a preparative regimen for allogeneic hematopoietic stem cell transplantation (allo-HSCT). It is intended to be used in combination with fludarabine for the treatment of eligible patients […]
Sun Pharmaceutical Industries (Sun Pharma) along with one of its fully-owned subsidiaries has reached an agreement with Celgene, a fully-owned subsidiary of Bristol Myers Squibb, to resolve the patent litigation pertaining to generic Revlimid (lenalidomide). The patent litigation is about the submission of an abbreviated new drug application (ANDA) for a generic version of lenalidomide […]
Natco Pharma has secured the final approval from the US Food and Drug Administration (FDA) of its abbreviated new drug application (ANDA) for Lenalidomide Capsules, 5mg, 1 Omg, 15mg, and 25mg, and the tentative approval of the 2.5mg and 20mg. Lenalidomide Capsules is the generic for Bristol-Myers Squibb’s REVLIMID, which is indicated in the US […]
CA-4948 phase 1 clinical trial : US biotech company Curis said that it has dosed the first patient with CA-4948 in a phase 1 clinical trial that is evaluating the small molecule IRAK4 kinase inhibitor for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). The phase 1 clinical trial for CA-4948 will […]
Bristol Myers Squibb and Acceleron Pharma have secured approval from the European Commission (EC) for their jointly developed erythroid maturation agent Reblozyl (luspatercept) for the treatment of transfusion-dependent anemia in adult patients. The approval of Reblozyl is for transfusion-dependent anemia caused by very low-, low- and intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts, who had […]