In a major development for the biotechnology sector, Adaptive Biotechnologies Corporation witnessed a remarkable 29% surge in its stock value following a key regulatory milestone. The company announced that its flagship product, the clonoSEQ Assay, has secured In Vitro Diagnostic Regulation (IVDR) certification in the European Union, making it the first and only test approved […]
Johnson & Johnson (NYSE: JNJ) has recently announced encouraging outcomes from the second interim analysis of the Phase 3 CARTITUDE-4 study, which is pivotal in the evolving landscape of multiple myeloma treatment. This significant study assesses the effectiveness of CARVYKTI (ciltacabtagene autoleucel; cilta-cel) against the standard therapies, which include combinations of pomalidomide, bortezomib, and dexamethasone […]
GSK plc has unveiled promising results from the DREAMM-7 phase III trial, which highlights a notable advancement in the treatment of relapsed or refractory multiple myeloma. The trial compared the effectiveness of Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone (BorDex) against the standard of care daratumumab plus BorDex combination. The findings, set to […]
Pfizer Inc. has announced a significant development in the treatment of multiple myeloma, a type of cancer that affects plasma cells in the bone marrow. The European Commission (EC) has granted conditional marketing authorization for ELREXFIO (elranatamab), a targeted immunotherapy designed for adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at […]
GSK plc has unveiled positive outcomes from the DREAMM-7 head-to-head phase III trial, evaluating Blenrep (belantamab mafodotin) as a treatment for relapsed or refractory multiple myeloma. This pivotal trial demonstrated a statistically significant progression-free survival (PFS) benefit for Blenrep combined with bortezomib and dexamethasone (BorDex) against the daratumumab plus BorDex regimen. Trial Details and Efficacy […]
Pfizer Inc. has earned accelerated approval from the U.S. Food and Drug Administration (FDA) for its innovative drug, ELREXFIO (elranatamab-bcmm). This drug aims to treat adult patients diagnosed with relapsed or refractory multiple myeloma (RRMM) who have undergone at least four previous therapy lines, including essential treatments. Rooted in Promising Clinical Trials The endorsement stems […]
Eugia Pharma Specialities Limited, a fully-owned subsidiary of India-based Aurobindo Pharma Limited, has received final approval from the US Food and Drug Administration (FDA). This nod enables the pharmaceutical company to manufacture and market the Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL), in a Single-Dose Vial. This product has been demonstrated to be bioequivalent and […]
Legend Biotech has announced the submission of a Type II variation application to the European Medicines Agency (EMA) for CARVYKTI (ciltacabtagene autoleucel or cilta-cel), based on data obtained from the CARTITUDE-4 study (NCT04181827). This study focuses on the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma who have undergone one to three prior […]
LaNova Medicines has signed an exclusive license deal worth over $600 million for its pre-clinical stage antibody drug conjugate (ADC) called LM-305 with AstraZeneca. LM-305 is designed to target G protein-coupled receptor, class C, group 5, member D (GPRC5D). The antibody drug conjugate consists of an anti-GPRC5D monoclonal antibody, a cytotoxic payload monomethyl auristatin E […]
NATCO Pharma said that it has launched additional strengths for the generic version of Revlimid (lenalidomide capsules), in the strengths of 2.5mg and 20mg in the US. The Indian pharma company has launched the product through its marketing partner Teva Pharmaceuticals, which is a US-based affiliate of Israeli pharma company Teva Pharmaceutical Industries. With the […]