Novartis and Bristol Myers Squibb (BMS) have both paused clinical trials of CAR-T cell therapies for lupus and other autoimmune diseases due to concerning safety findings. Novartis has placed holds on trials of rapcabtagene autoleucel (rap-cel), stopping screening, randomisation, and treatment administration in trials in lupus, myasthenia… Read More
Bristol Myers Squibb and immunotherapy developer Janux Therapeutics have announced a collaboration and exclusive worldwide license agreement. Under the terms of the agreement, the companies will develop an undisclosed, novel, tumour-activated therapeutic targeting a validated solid tumour antigen expressed across several human cancer types. Janux… Read More
Bristol Myers Squibb has extended its long-term research collaboration with global CRDMO Syngene until 2035. The expanded agreement broadens the scope of integrated services across the drug development lifecycle spanning discovery, translational sciences, pharmaceutical development and manufacturing, clinical trials, data, and information technology services, to enable seamless progression… Read More
The US Food and Drug Administration (FDA) has approved a new indication for Breyanzi (lisocabtagene maraleucel) as the first chimeric antigen receptor (CAR)-T therapy in the US for treatment of adults with marginal zone lymphoma (MZL) who have failed treatment with or relapsed after two or more prior lines… Read More
Bristol Myers Squibb has shared its first results in chronic, refractory autoimmune diseases from the Phase I Breakfree-1 study of its investigational, autologous CD19-targeted NEX-T CAR T cell therapy BMS-986353 (CC-97540). The data evaluates a total of 71 treated patients across the systemic sclerosis (SSc), systemic lupus… Read More
Bristol Myers Squibb has announced plans to acquire in vivo CAR-T company Orbital Therapeutics for $1.5 billion. The acquisition includes Orbital’s lead RNA immunotherapy preclinical candidate currently in IND-enabling studies, OTX-201, which comprises an optimised circular RNA encoding a CD19-targeted CAR for in vivo… Read More
BioNTech and Bristol Myers Squibb have revealed global interim Phase II data for their PD-L1xVEGF-A bispecific antibody pumitamig in patients with extensive-stage small cell lung cancer (ES-SCLC) which shows encouraging antitumour activity. The data for pumitamig plus chemotherapy showed a 76.3% confirmed objective response rate (cORR), 100%… Read More
NHS England has become the first national health service in Europe to offer Bristol Myers Squibb’s injectable cancer immunotherapy nivolumab (Opdivo). Nivolumab is a monoclonal antibody that binds to PD-1 (programmed death-1) on T-cells. The jab can be used to treat 15 cancer types, including… Read More
Bristol Myers Squibb (BMS) is to acquire cell therapy developer 2seventy bio for approximately $286 million. Under the terms of the agreement, BMS will commence a tender offer to acquire all outstanding shares of 2seventy bio at a price of $5.00 per share in an all-cash transaction. … Read More
DDW’s Megan Thomas reflects on the impact of AbbVie’s failed schizophrenia trials. Earlier this month, AbbVie provided updates confirming that its two Phase II EMPOWER trials investigating emraclidine as a once-daily, oral monotherapy treatment for adults with schizophrenia who are experiencing an acute exacerbation of psychotic symptoms, have failed in… Read More
The US Food and Drug Administration (FDA) has approved Cobenfy (xanomeline and trospium chloride) capsules for the treatment of schizophrenia in adults. It is the first antipsychotic drug approved to treat schizophrenia that targets cholinergic receptors as opposed to dopamine receptors, which has long been the… Read More
The US Food and Drug Administration (FDA) has granted accelerated approval of Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). It is approved in adult patients who have… Read More
Bristol Myers Squibb has completed its acquisition of RayzeBio for approximately $4.1 billion, adding radiopharmaceutical therapeutics (RPTs) to its pipeline. Chris Boerner, Chief Executive Officer, Bristol Myers Squibb, said: “By strengthening and further diversifying our oncology pipeline beyond I-O, we will unlock exciting opportunities that support… Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Bristol Myers Squibb’s advanced melanoma drug Opdualag (nivolumab-relatlimab) for patients from the age of 12. Opdualag was authorised through Project Orbis, a global partnership between the MHRA, the Therapeutics Goods Administration in Australia, Health Canada,… Read More
Bristol-Myers Squibb has received manufacturing and marketing approval in Japan for Abecma (idecabtagene vicleucel) as a third-line therapy for relapsed or refractory multiple myeloma (RRMM). Abecma is a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy. It is now approved for RRMM patients… Read More
The US Food and Drug Administration (FDA) has expanded the use of Bristol Myers Squibb’s Reblozyl (luspatercept-aamt) to include first-line treatment of anaemia in adults with lower-risk myelodysplastic syndromes (MDS). The approval is for the treatment of anaemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult… Read More
