Today, just two in ten patients have access to CAR-T therapy in the US. Considering this challenging landscape, the shift has focused from academic centers to community clinics, as they may be able to serve more patients.
OneChain Immunotherapeutics has received €1.9m from the Spanish Ministry of Science and Innovation to advance a ‘groundbreaking’ CAR-T therapy for acute lymphoblastic leukemia type T into clinical development.
The Committee of Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended Janssen’s CARVYKTI (cilta-cel) for the earlier treatment of relapsed and refractory multiple myeloma (RRMM).
Stella Vnook, a seasoned veteran in the pharmaceutical industry with extensive experience in senior leadership roles at Catalent, Merck, and Diverse Biotech, has been a prominent figure in the field, particularly in oncology, for over 25 years.
A collaboration to expand autologous CAR-T programs into trials for multiple cancers in a cost-efficient way, has been formed by BioNTech SE and Autolus Therapeutics plc.
Upon hearing the phrase ‘cancer treatment’, the first word that can typically spring to mind is chemotherapy – a primary therapy which uses powerful chemicals to destroy rapidly growing cancer cells in the body.
Healthcare industry professionals scored cell and gene therapy (CGT) as the industry trend to have the greatest impact on the pharmaceutical industry in 2024, in a recent survey launched by data and analytics firm GlobalData.
CASI Pharmaceuticals and Juventas Cell Therapy recently received approval from China's National Medical Products Administration (NMPA) for Yuanruida, a domestic CD19-targeting CAR-T therapy for relapsed/refractory B-Cell Acute Lymphocytic Leukemia.
Terumo Blood and Cell Technologies, a medical tech company, and BioCentriq, a cell therapy contract development and manufacturing organization (CDMO), are working together to demonstrate the capabilities of Terumo’s automated cell and gene therapy platforms...
At Advanced Therapies Europe 2023, BioPharma Reporter caught up with ScaleReady's Jenny Stjernberg to discuss her work at the biotech company, her journey from academia to commercial and female representation in the cell and gene therapies industry....
Janssen Biotech has entered into a worldwide collaboration and license agreement with Cellular Biomedicine Group to develop, manufacture and commercialize next-generation chimeric antigen receptor (CAR) T-cell therapies for the treatment of B-cell malignancies....
Bristol Myers Squibb will boost its cell therapy manufacturing network with in-house viral vector production thanks to the acquisition of Novartis’ Libertyville, Illinois facility.
The clinical stage company announces that its potential treatment for relapsed or refractory multiple myeloma receives nod for speedier review by the FDA.
A T-cell engaging bispecific antibody developed by Roche has got its first green light in Canada for the treatment of relapsed or refractory forms of the blood cancer diffuse large B-cell lymphoma (DLBCL).
California based, Theragent, a cell therapy CDMO, has signed a multi-year exclusive contract with Insight68, an AI-driven software provider that aims to digitalize and streamline the cell therapy manufacturing process.
Vector BioMed, a CDMO specializing in the manufacture of lentiviral vectors, launched this week; its first financing round was led by Viking Global Investors and Casdin Capital.
Gilead’s CAR-T therapy Yescarta (Axicabtagene ciloleucel) has been recommended for routine use on the National Health Service (NHS) in England for patients with an aggressive form of lymphoma.
The US Food and Drug Administration (FDA) has approved Kite’s retroviral vector (RVV) manufacturing facility in Oceanside, California, for commercial production.
Penn spinout, Verismo Therapeutics, says the FDA has granted Orphan Drug Designation (ODD) to its KIR-CAR T-cell immunotherapy drug, SynKIR-110, for the treatment of patients with mesothelin-expressing mesotheliomas.
San Francisco based Cellares is partnering with Lexington, Massachusetts headquartered iVexSol to accelerate and improve the quality of viral vector manufacturing and transduction.
The European Commission (EC) has approved Kite’s CAR T-cell therapy, Yescarta, (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy.
Measuring potency for gene and cell therapies is not so clear-cut, and some companies have hit roadblocks in their submissions to regulatory agencies as a result.
The BIO International Convention in San Diego this week heard the US-based Center for Breakthrough Medicines (CBM) is to speed up plans to build what it calls the largest cell therapy manufacturing operation worldwide.
Lonza has added new integrated capabilities in cell binding, cell separation, and bead removal to its closed, automated, and scalable platform for personalized therapy manufacturing.
Janssen’s Carvykti, a therapy for multiple myeloma, has been approved for conditional marketing authorization (CMA) by the European Medicines Agency (EMA).
IASO Biotherapeutics and Innovent Biologics have announced that the FDA has granted Orphan Drug Designation (ODD) to their fully human anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy for the treatment of relapsed and/or...
Kyverna Therapeutics, a cell therapy company engineering a new class of therapies for autoimmune diseases, has closed an oversubscribed $85m Series B financing round led by Northpond Ventures.
ATMPS Ltd, a UK developer of blockchain-based cell orchestration platforms for advanced therapies is collaborating with US quality and compliance consultancy, Assurea LLC, to develop a fully complaint blockchain approach for end-to-end supply chain management...
Novartis has introduced its T-Charge platform at ASH 2021, which it says will serve as the foundation for various new investigational CAR-T cell therapies in its pipeline.
Oxford Biomedica plc has announced an extended commercial supply agreement with Novartis for the manufacture of lentiviral vectors for several Novartis CAR-T products.
Biolife Solutions and its subsidiary SciSafe have opened a new 40,000 square-foot biorepository Center of Excellence in Amsterdam, located next to Schiphol Airport.
Novartis’s Kymriah CAR-T therapy did not meet its primary endpoint of event-free survival in a phase 3 study in patients with aggressive B-cell non-Hodgkin lymphoma (NHL) after relapse or lack of response to first-line treatment.
The partners announce the addition of a manufacturing facility that will become the fourth in Legend’s network. It is expected to be operational by 2023.
Autolus Therapeutics is seeking a partner for clinical development of an ACE2 fusion soluble receptor decoy designed to work against SARS-CoV-2 and its variants.
Precigen claims breakthroughs in CAR T cell therapy manufacturing that will eventually allow cancer centers to enable treatments earlier and at a lower cost.
From new research offering promise for children's cancer to FDA registrations, we track the progress made in the past few weeks in terms of advancing CAR T-cell therapy in a number of markets.
AbbVie and Caribou Biosciences have entered into a collaboration and license agreement for the research and development of chimeric antigen receptor (CAR)-T cell therapeutics.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) announced they will perform an accelerated assessment of the Marketing Authorization Application (MAA) for Janssen’s investigational CAR-T therapy, ciltacabtagene...
A new study suggests that CAR T-cells, which are already used to treat certain blood cancers, may also be successful against solid tumors if combined with other immunotherapeutic approaches.
Three studies, which are being presented during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, report promising results in the use of cutting-edge genome editing and cellular therapies for hard-to-treat blood disorders and...