Zydus Lifesciences (previously called Cadila Healthcare) said that it has secured final approval from the US Food and Drug Administration (FDA) to market Bortezomib for Injection, 3.5 mg/vial, Single-Dose Vial. Bortezomib for Injection is the generic of Velcade (bortezomib), which has a market size of $1.17bn as per IQVIA MAT March 2022. It is used […]
Bristol Myers Squibb (BMS) has secured priority review from the US Food and Drug Administration (FDA) for its supplemental biologics license application (sBLA) for Breyanzi (lisocabtagene maraleucel). The sBLA is for expanding the current indication of the CD19-directed chimeric antigen receptor (CAR) T cell therapy to be used in the treatment of relapsed or refractory […]
Dr. Reddy’s Laboratories (Dr. Reddy’s Labs) has agreed to divest its rights to E7777, an engineered IL-2-diphtheria toxin fusion protein, and certain related assets to US-based Citius Pharmaceuticals in a deal worth up to $150 million. The Indian pharma company will get $40 million upfront upon the closing of the deal. It will be eligible […]
US pharma giant Pfizer has agreed to acquire Trillium Therapeutics, a publicly listed Canadian clinical stage immuno-oncology company, for $18.5 per share or $2.26 billion in an all-cash deal. The portfolio of Trillium Therapeutics has biologics that have been designed to boost the ability of patients’ innate immune systems for detecting and killing cancer cells. […]
Rylaze FDA approval : Jazz Pharmaceuticals has secured approval for its leukemia drug Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn or JZP458) from the US Food and Drug Administration (FDA). The Irish biopharma company bagged the approval for the drug to be used as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic […]
Bioniz Therapeutics has secured orphan drug designation for BNZ-1 from the European Commission (EC) for the treatment of cutaneous T-cell lymphoma (CTCL), a rare type of skin cancer. Previously, BNZ-1 was given orphan drug designation by the US Food and Drug Administration (FDA). Recently, Bioniz Therapeutics wrapped up a phase 2 study of BNZ-1 in […]
Thermo Fisher Scientific has entered into a significant agreement with Chinese cell therapy leader JW Therapeutics, granting non-exclusive commercial access to its Gibco CTS Dynabeads CD3/CD28 technology. This collaboration is set to accelerate the clinical development and commercial manufacturing of CAR-T therapies in China, focusing on JW Therapeutics’ pioneering product, relmacabtagene autoleucel (relma-cel). Enhancing CAR-T […]
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 […]
Roche has secured approval from the US Food and Drug Administration (FDA) for its cobas EZH2 Mutation Test as a companion diagnostic for TAZVERIK (tazemetostat), developed by Epizyme. According to the Swiss healthare company, the molecular test can detect abnormalities in the EZH2, or Enhancer of Zeste Homolog 2, gene in patients having follicular lymphoma […]
Takeda Pharmaceutical has secured extended approval for ADCETRIS (brentuximab vedotin) in the European Union to include the treatment of previously untreated systemic anaplastic large cell lymphoma (sALCL) in adult patients. The approval from the European Commission (EC) is for the combination of ADCETRIS with CHP (cyclophosphamide, doxorubicin, prednisone. It comes in the wake of a […]