AGC Biologics to Manufacture First-ever FDA Approved Gene Therapy for Early-onset MLD, Orchard Therapeutics’ Lenmeldy™
Today, we announced that the U.S. Food and Drug Administration (FDA) has cleared our Milan site to begin commercial manufacturing for the lentiviral vector and genetically modified cell drug product (DP) of Orchard Therapeutics’ Lenmeldy™ (atidarsagene autotemcel), a hematopoietic stem cell (HSC) gene therapy for the treatment of pre-symptomatic late infantile, pre-symptomatic early juvenile and early symptomatic early juvenile metachromatic leukodystrophy (MLD). Lenmeldy received approval by the FDA on Monday, March 18.
MBrace Therapeutics Appoints Steve Alley as Chief Scientific Officer
SAN DIEGO (March 5, 2024) – MBrace™ Therapeutics, Inc. (“MBrace”), a clinical-stage biopharmaceutical company devoted to improving the lives of patients with cancer by developing novel antibody-drug conjugates (ADCs), today announced the appointment of Steve Alley, Ph.D., as chief scientific officer. Dr. Alley joins MBrace with over 20 years of experience at Seagen, a world-leader in ADCs that was acquired by Pfizer in 2023.
Inoviv Launches NeuroKey-3™, A Quantitative Multiplexed IP-MS Assay to Measure Key Low-Level Markers in Neurodegeneration
LONDON, March 1, 2024 /PRNewswire/ — Biomarker pioneer, Inoviv, announces the launch of its proprietary NeuroKey-3™ assay, an end-to-end service offering to measure key low-level markers in neurodegeneration in human plasma. The launch of NeuroKey-3™ signifies an important milestone in Inoviv’s mission to generate novel molecular insights that transform drug development and healthcare globally. Inoviv will […]
Inoviv Secures Investment to Expand Quantitative Proteomics Product Offerings to Accelerate Drug Development Pipelines
LONDON–(BUSINESS WIRE)–Biomarker pioneer Inoviv has secured significant funding from venture capital firm Hoxton Ventures and leading investment manager Foresight Group to expand the delivery of highly accurate, fully quantitative targeted biomarker workflows and panels. Building on previous funding from Hoxton Ventures, this latest investment will enable Inoviv to further expand its commercial activities to support […]
Allogene Therapeutics, Foresight Diagnostics Partner to Develop MRD Test for CAR T-Cell Therapy Trial
NEW YORK – Allogene Therapeutics and Foresight Diagnostics on Thursday said they will partner to develop an in vitro diagnostic test to select patients with minimal residual disease (MRD) after first-line consolidation therapy for a Phase II clinical trial of its anti-CD19 CAR T-cell therapy cemacabtagene ansegedleucel (cema-cel) in large B-cell lymphoma (LBCL). San Francisco-based […]
AGC Biologics announces plans for New Manufacturing Site in Yokohama Japan
The new four-story 20,000 m² facility will feature mammalian cell culture, messenger RNA and cell therapy services and be operational in 2026 Today, we announced plans to construct a new manufacturing facility at AGC Inc.’s Yokohama Technical Center in Japan. The new site is a part of our strategic growth strategy to create more high-quality […]
MBrace Therapeutics Announces Initiation of Patient Dosing in Phase 1 Clinical Trial Evaluating Investigational Antibody-Drug Conjugate MBRC-101
SAN DIEGO (December 19, 2023) – MBrace™ Therapeutics, Inc. (“MBrace”), a clinical-stage biopharmaceutical company devoted to improving the lives of patients with cancer by developing novel antibody-drug conjugates (ADCs), today announced the successful initiation of patient dosing in its Phase 1/1b study evaluating MBRC-101 in patients with advanced metastatic solid tumors refractory to standard treatment. […]
AGC Biologics to Prepare Late-Phase and Commercial Runs for Immunocore
Global CDMO’s Heidelberg site to support Process Performance Qualification for IMC-F106C late-stage program and prepare for commercial readiness. Today, we announced a new late-stage clinical and process performance qualification (PPQ) project at our Heidelberg, Germany site with Immunocore Holdings Plc (Nasdaq: IMCR). Immunocore intends to use the Heidelberg site to complete late-stage manufacturing and prepare for […]
Federal Jury Finds Guardant Health Willfully Infringes University of Washington Duplex Sequencing Patents Exclusively Licensed to TwinStrand Biosciences, Inc., Awards $83.4M in Damages; PTAB Rejects Invalidity Arguments on UW Patents
SEATTLE, Nov. 15, 2023 /PRNewswire/ — TwinStrand Biosciences®, the pioneer in Duplex Sequencing technology, which delivers accurate insights to researchers in applications ranging from residual cancer detection to genetic toxicology, announced a successful jury verdict in the federal patent infringement case it brought with the University of Washington against Guardant Health. The jury found that […]
PhasED-Seq™ MRD Detection: Accurate & Early Cancer Monitoring
Nov 28, 2023 AURORA, Colo., Nov. 8, 2023 /PRNewswire/ – Foresight Diagnostics, a leader in ultrasensitive minimal residual disease (MRD) detection testing, announced today that six studies utilizing their patented PhasED-Seq™ technology will be presented at the 65th American Society of Hematology Annual Meeting and Exposition (ASH 2023) taking place December 9-12, 2023, in San Diego, California. Four of these studies have been […]
