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Backed by ARCH Venture Partners and Fujifilm, as well as technology licensed from MIT, Tome is looking to create curative cell and integrative gene therapies.
In this episode we dive into regulation, real-time management, and AI’s various applications and how it can streamline different processes with guests from Microsoft and IQVIA.
As CAR T cell therapies attract significant biopharma investment, experts say there is plenty of space in the growing market for both treatments that use patients’ own cells and for those that rely on donor cells.
The companies have received all required regulatory approvals to complete the deal, the largest for the sector in the past three years and the biggest for the hot antibody-drug conjugate market.
The FDA decided last month to convene an advisory committee to discuss the companies’ proposed use of Abecma in earlier lines of treatment for multiple myeloma. Data presented Monday at the American Society of Hematology annual meeting provides a clue as to why.
With the acquisition, AstraZeneca will gain access to Icosavax’s investigational combination vaccine IVX-A12, which is being developed for respiratory syncytial virus and human metapneumovirus in older adults.
Bristol Myers Squibb has bought the rights to develop and commercialize SystImmune’s potentially first-in-class, bi-specific antibody-drug conjugate for lung and breast cancer as well as other solid tumors.
Following the regulator’s administrative complaint and threat of a lawsuit in federal court, Sanofi has decided to terminate its licensing deal with Maze Therapeutics to avoid a long litigation process.
The trial demonstrated that C3G glomerulopathy patients treated with the oral factor B inhibitor saw a significant reduction in protein in their urine. The results come days after iptacopan won the FDA’s green light for a rare blood disease.
The Indiana-based pharma shed shares after a study published Monday in JAMA showed “substantial” weight gain after patients discontinued treatment with the GLP-1 receptor agonist.
The company’s fiscal report for 2023 details revenue losses of $539 million and layoffs of 1,100 employees but notes that future GLP-1 manufacturing revenues could help stabilize its finances.
A CAR-T cell therapy for autoimmune diseases generated significant attention at the 2023 American Society of Hematology (ASH) annual meeting and Arcellx and Seagen posted promising data.
The New York-based pharma reported at ASH that odronextamab had an 80% objective response rate, with 73% of patients experiencing a complete response.
Patients treated with the investigational sickle cell therapy saw an increase in hemoglobin levels and improved red blood cell parameters.
The investigational allogeneic CAR-T therapy P-BCMA-ALLO1 appears to be more effective following strong immunosuppressive preconditioning.
These factors, along with bluebird bio’s failure to receive a priority review voucher, all hurt the company’s stock price following Lyfgenia’s approval.
Friday’s FDA approval of Vertex-CRISPR’s Casgevy and bluebird bio’s Lyfgenia has immediately revealed startling differences between these two gene therapies: price and a black-box warning.
Along with CRISPR/Cas9-based Casgevy—developed by Vertex Pharmaceuticals and CRISPR Therapeutics—the regulator on Friday approved bluebird bio’s Lyfgenia, a second gene therapy for sickle cell disease.
Another Flagship-founded company is shutting down its operations, according to an SEC filing. Axcella Health, which was focused on the development of a long COVID therapeutic, is no more.
Plexxikon, which was acquired by Daiichi Sankyo, and Novartis have agreed to settle a patent case involving the cancer drug Tafinlar and its sale in the U.S.