Author Archives: Marisa Wexler MS

Europe Awaits Proposed New Framework for Sharing Health Data

The European Commission is expected to propose a new governing framework for health data next month, called the European Health Data Space (EHDS), with the aim of connecting national health systems to facilitate secure and efficient transfer of data across systems in different European nations. The move is expected to…

FDA Designates CT103A, CAR T-cell Therapy, an Orphan Drug

The U.S. Food and Drug Administration (FDA) has granted orphan drug status to CT103A, an experimental CAR T-cell therapy that IASO Biotherapeutics and Innovent Biologics are developing to treat relapsed or refractory multiple myeloma. Orphan drug designation is given to therapies with a potential to substantially improve…

Immune Therapy AO-176 Awarded FDA’s Orphan Drug Designation

The U.S. Food and Drug Administration (FDA) has granted orphan drug status to Arch Oncology‘s experimental immune-modulating therapy AO-176 as a potential treatment for relapsed or refractory multiple myeloma. This designation, given to therapies with the potential to improve care for conditions that affect fewer than 200,000 people…

FDA Expects Decision on Cilta-cel Approval by February 2022

The U.S. Food and Drug Administration (FDA) is expected to decide by the end of February whether or not to approve ciltacabtagene autoleucel, known as cilta-cel, an investigational CAR T-cell therapy for the treatment of relapsed or refractory multiple myeloma. The FDA extended its expected decision date to…

PT-112 Shows Promise for Heavily Treated Myeloma Patients

Phosplatin Therapeutics‘ investigational medication PT-112 showed promising efficacy and safety data in an early clinical trial of heavily-pretreated people with relapsed or refractory multiple myeloma. The findings were shared in a presentation, “A Phase I Dose Escalation Study of PT-112 in Patients with Relapsed or…

GSK Seeks Ideas for Improving Life in Myeloma Community

A new initiative by GlaxoSmithKline (GSK) is seeking project proposals that will address key needs for people in the multiple myeloma community. Submissions for the Target the Future Think Tank Challenge are open until Feb. 11. Anyone in the community, including patients, caregivers, researchers, clinicians, and advocates, all…

Investigational Myeloma Treatment KP1237 Wins FDA Orphan Drug Status

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Kleo Pharmaceuticals‘ KP1237, an investigational treatment for multiple myeloma. The designation grants various development incentives to medications that address rare disorders affecting fewer than 200,000 people annually in the U.S. Incentives include…