Jennifer Mandal

Mar 29, 2024 | healio.com | Rob Volansky |Shenaz Bagha |Jennifer Mandal |Jinoos Yazdany

You've successfully added Rheumatoid Arthritis to your alerts. You will receive an email when new content is published. Click Here to Manage Email Alerts We were unable to process your request. Please try again later. If you continue to have this issue please contact [email protected]. Compared with the general U.S. population, Navajo Nation in Arizona, New Mexico and Utah has five times the prevalence of rheumatoid arthritis.

Nov 1, 2023 | mondaq.com | Jennifer Mandal

The Cellular, Tissue, and Gene Therapies Advisory Committee of the FDA is meeting tomorrow, Tuesday, October 31, 2023, to review a Biologics License Application by Vertex Pharmaceuticals Inc. for exagamglogene autotemcel (exa-cel). Exa-cel is a cell-based gene therapy product composed of the patient's own hematopoietic stem and progenitor cells (HSPCs) edited at the BCL11A gene with a CRISPR/Cas9 construct.

Oct 31, 2023 | jdsupra.com | Jennifer Mandal

The Cellular, Tissue, and Gene Therapies Advisory Committee of the FDA is meeting tomorrow, Tuesday, October 31, 2023, to review a Biologics License Application by Vertex Pharmaceuticals Inc. for exagamglogene autotemcel (exa-cel).  Exa-cel is a cell-based gene therapy product composed of the patient’s own hematopoietic stem and progenitor cells (HSPCs) edited at the BCL11A gene with a CRISPR/Cas9 construct.

Oct 3, 2023 | jdsupra.com | Jennifer Mandal

On September 20, Alvotech announced that FDA has accepted the resubmission of its Biologics License Application (BLA) for AVT02, a high concentration, interchangeable biosimilar to HUMIRA (adalimumab). FDA has set a Biosimilar User Fee Act (BsUFA) goal date for approval of the resubmitted AVT02 BLA of February 24, 2024.

Oct 2, 2023 | jdsupra.com | Jennifer Mandal

On September 20, Merck announced that the U.S. Food and Drug Administration (FDA) granted priority review status to Merck’s supplemental Biologics License Application (sBLA) seeking approval for its anti-PD-1 therapy KEYTRUDA (pembrolizumab) in combination with external beam radiotherapy (EBRT) plus concurrent chemotherapy, followed by brachytherapy, as a treatment for newly diagnosed high-risk locally advanced cervical cancer.