staff reporter
Articles Authored by staff reporter
FDA Warns of T-Cell Malignancy Risk Following Autologous CAR T-Cell Therapy
Although the agency said the benefits of these treatments still outweigh their risks, it is investigating the potential for serious adverse outcomes and assessing the need for regulatory action.
AbbVie Eyeing Accelerated Approval Pathway for c-Met-Targeted Antibody-Drug Conjugate in NSCLC
In the LUMINOSITY trial, patients with EGFR wild-type advanced NSCLC had overall response rates of 23 percent to 35 percent based on their level of c-Met overexpression.
KSQ Therapeutics Gets FDA Clearance to Begin Phase I/II Trial of CRISPR-Cas9-Edited TIL Therapy
The firm will evaluate its autologous tumor-infiltrating lymphocyte therapy candidate in melanoma, head and neck cancer, and non-small cell lung cancer.
UniQure Fabry Disease Gene Therapy Gets FDA IND Clearance
Following clearance of the investigational new drug application, the company is planning a first-in-human dose escalation trial in the US.
PlaqueTec Enrolling UK Patients in Blood-Based Biomarker Study for Coronary Artery Disease
Investigators are using the firm's liquid biopsy system to collect blood samples and identify proteins and biomolecules relevant to pathobiology.
Personalis, Tempus Partner to Commercialize Blood-Based Minimal Residual Disease Test
Tempus will market Personalis' NeXT Personal Dx liquid biopsy assay while Personalis completes its clinical validation in more indications.
Thermo Fisher Scientific, Pfizer Canada Grant C$300K to Study NGS in Colorectal Cancer Care
The recipients of both grants will study the effects of bringing next-generation sequencing-based testing into a community cancer center.
Carisma Therapeutics to Start Phase I Trial of CAR Monocyte in HER2-Positive Cancers
The FDA cleared the firm's investigational new drug application to study its autologous cell therapy CT-0525 in patients with solid tumors overexpressing HER2.
Candel Therapeutics Lays off Half its Workforce, Refocuses on Most Advanced Oncology Programs
By reducing staff and lowering its operating costs, Candel expects to fund operations into the fourth quarter of 2024.
Quest Diagnostics, Scipher Medicine Collaborate on Rheumatoid Arthritis Test
Quest will provide RNA extraction and sequencing services for Scipher's PrismRA test, a blood-based molecular test for predicting patient response to TNF inhibitors.