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 […]
Bristol Myers Squibb (NYSE: BMY) has unveiled primary analysis results from the TRANSCEND FL clinical trial at the 2023 American Society of Hematology (ASH) Annual Meeting. This trial, part of a global, multicenter Phase 2 study, evaluates the efficacy of Breyanzi (lisocabtagene maraleucel, liso-cel) in patients with relapsed or refractory follicular lymphoma (FL). TRANSCEND FL: […]
Dr. Reddy’s Laboratories, an Indian pharmaceutical company, announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for a comprehensive review of its proposed biosimilar rituximab candidate, DRL_RI. This news comes on the heels of similar acceptance from the European Medicines Agency (EMA) and the United Kingdom’s Medicines and […]
Eli Lilly’s oncology arm, Loxo@Lilly, disclosed that The New England Journal of Medicine (NEJM) has published an extensive analysis of results from the BRUIN Phase 1/2 trials on pirtobrutinib, a reversible Bruton’s tyrosine kinase (BTK) inhibitor. Pirtobrutinib is being investigated for use in adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who […]
BeiGene has secured the approval of the US Food and Drug Administration (FDA) for the company’s Brukinsa (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Brukinsa FDA approval is backed by the findings of two global phase 3 clinical trials wherein Brukinsa showed superior efficacy and […]
AbbVie said that the phase 3 GLOW study in chronic lymphocytic leukemia (CLL) investigating the combination of IMBRUVICA (ibrutinib) plus VENCLEXTA/VENCLYXTO (venetoclax) (I+V) has met its primary endpoint of superior progression-free survival (PFS). The GLOW clinical trial is comparing the efficacy and safety of the ibrutinib, venetoclax combination against chlorambucil plus obinutuzumab (C+O) for first-line […]
Ascentage Pharma has entered into a clinical collaboration with Acerta Pharma, the hematology research and development center of excellence of AstraZeneca to assess the combination of Bcl-2 and Bruton’s Tyrosine Kinase (BTK) inhibitors in a type of lymphoma. As per the collaboration terms, Ascentage Pharma will sponsor a clinical trial to evaluate the efficacy and […]