Bioarray Genetics

Industry Outlook

PRNewswire | July 10, 2023

Poseida Therapeutics, Inc. a clinical-stage cell and gene therapy company advancing a new class of treatments for patients with cancer and rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for P-CD19CD20-ALLO1, the Company's first allogeneic dual CAR-T cell product candidate, which targets both CD19 and CD20 antigens for the treatment of relapsed or refractory B-cell malignancies and is being devel...

Industrial Impact

Novaliq GmbH | August 10, 2022

Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, announced the submission of a New Drug Application to the U.S. Food and Drug Administration seeking approval for CyclASol® a proposed novel treatment for the signs and symptoms of dry eye disease. CyclASol® has demonstrated in two pivotal studies fast onset of therapeutic effect in the indication, clinical meaningful improveme...

Cell and Gene Therapy

Merck and Orna Therapeutics | August 17, 2022

Merck known as MSD outside the United States and Canada, and Orna Therapeutics, a biotechnology company pioneering a new investigational class of engineered circular RNA therapies, today announced a collaboration agreement to discover, develop, and commercialize multiple programs, including vaccines and therapeutics in the areas of infectious disease and oncology. Under the terms of the agreement, Merck will make an upfront payment to Orna of $150 million, which will be expensed b...

Cell and Gene Therapy

Imara | November 22, 2021

Imara Inc. a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare inherited genetic disorders of hemoglobin and other serious diseases, today announced a change to the primary endpoint for the Ardent clinical trial, a Phase 2b study of tovinontrine (IMR-687) in patients with sickle cell disease (SCD), based on the recommendation of the U.S. Food and Drug Administration (FDA). Imara requested f...