Ohio Living

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...

FierceBiotech | February 11, 2020

The FDA has placed a clinical hold on LogicBio Therapeutics’ planned genome editing trial. LogicBio wants to trial the therapy in methylmalonic acidemia (MMA) patients aged two years and up but has run into resistance at the FDA. Details of the nature of the regulatory resistance and how soon it is likely to be resolved are scarce. LogicBio provided scant information in its statement to disclose the FDA clinical hold. According to analysts at Jefferies who spoke to management at LogicBio, ...

INDUSTRIAL IMPACT

BioNTech SE | February 22, 2022

BioNTech SE and Medigene AG a clinical-stage immuno-oncology company focusing on the development of T cell immunotherapies, announced that they have entered a multi-target research collaboration to develop T cell receptor (TCR) based immunotherapies against cancer. The initial term of the collaboration is three years. Medigene will contribute its proprietary TCR discovery platform for the development of TCRs against multiple solid tumor targets nominated by BioNTech. Medigene&rsqu...

Emergent BioSolutions | October 09, 2020

NIAID has initiated a Phase 3 clinical trial to evaluate the safety, tolerability, and efficacy of hyperimmune globulin products, including Emergent’s COVID-19 Human Immune Globulin (COVID-HIG), as a potential treatment in adult patients hospitalized with COVID-19. Emergent is planning additional clinical trials to evaluate COVID-HIG for potential use in other patient populations or individuals at high risk of exposure. Emergent BioSolutions, Inc. Inc. (NYSE:EBS) today announced the initia...