In a significant development in the healthcare industry, Bristol Myers Squibb (NYSE: BMY) and 2seventy bio, Inc. (Nasdaq: TSVT) have announced a favorable vote by the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) regarding Abecma (idecabtagene vicleucel). The committee’s 8-3 vote supports the therapy’s benefit/risk profile for patients with triple-class exposed […]
In a significant move within the pharmaceutical industry, Novartis has entered into an agreement to launch a voluntary public takeover offer to acquire MorphoSys AG, a Germany-based global biopharmaceutical company renowned for developing innovative medicines in oncology. This acquisition, valued at EUR 2.7 billion, or EUR 68 per share, marks a strategic step for Novartis […]
AstraZeneca has announced a definitive agreement to acquire Gracell Biotechnologies Inc. (Gracell, NASDAQ: GRCL) for an upfront cash payment of $1.0 billion, representing a 62% premium to Gracell’s closing market price on December 22, 2023. The deal includes an additional contingent value right of $0.30 per ordinary share, bringing the total potential transaction value to […]
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 […]
Takeda Pharmaceutical Company has revealed promising interim results from its global Phase 3 trial of TAK-755, a recombinant ADAMTS13 protein in development for the prophylactic treatment of congenital thrombotic thrombocytopenic purpura (cTTP). This makes TAK-755 the only recombinant ADAMTS13 protein under development, targeting an unmet medical need in TTP patients by replacing the missing or […]
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 […]
Bristol Myers Squibb (BMY) has secured full marketing authorization for Reblozyl (luspatercept) from the European Commission (EC) for treating anemia associated with non-transfusion-dependent (NTD) beta thalassemia in adult patients. Presently, Reblozyl is approved in the European Union (EU), the US, and Canada for addressing anemia resulting from transfusion-dependent beta thalassemia and transfusion-dependent lower-risk myelodysplastic syndromes. […]
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 […]
The Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson, announced the US Food and Drug Administration’s approval of its first bispecific T-cell engager antibody, TECVAYLI (teclistamab-cqyv). The medication is intended for the treatment of relapsed or refractory multiple myeloma patients. TECVAYLI is indicated for patients previously treated with a proteasome inhibitor, immunomodulatory drug, and […]
Pfizer has agreed to acquire Global Blood Therapeutics (GBT), a publicly-listed American biopharma company, in a deal worth around $5.4 billion with an aim to boost its presence in rare hematology. Global Blood Therapeutics is particularly focused on developing drugs for the treatment of sickle cell disease (SCD). The company’s sickle cell disease drug Oxbryta […]
