FDA Extends Review Period for Gene Therapies for Beta-Thalassemia, Cerebral Adrenoleukodystrophy
The FDA extended the target dates for beti-cel and eli-cel to allow time to review additional clinical information for both applications.
Miscellaneous Hematological Agents
Red Cross Says US Blood Supply at Dangerously Low Level
People who have received COVID-19 vaccines can donate blood and platelets as long as they are symptom-free
Novel NMDA Receptor Blocker Designated Orphan Drug for Subarachnoid Hemorrhage
NP10679 is an investigational subunit-specific NMDA receptor inhibitor.
Daratumumab/Hyaluronidase-fihj With Carfilzomib, Dexamethasone Approved for Multiple Myeloma
Results showed an overall response rate of 84.8%.
Lack of Confirmatory Trials Leads to Withdrawal of Multiple Myeloma Treatment
Continued approval required further verification and description of clinical benefit in confirmatory trials.
One-Time Gene Therapy Gets Priority Review for Beta-Thalassemia
Betibeglogene autotemcel (beti-cel) is a one-time gene therapy that works by adding functional copies of a modified form of the β-globin gene into a patient’s own hematopoietic stem cells.
Guideline Updated for Blood Management During Heart Surgery
Measures of blood conservation should be undertaken, including retrograde autologous priming of cardiopulmonary bypass circuit
Red Cross Warns of Severe Blood Shortage
Hospitals’ need for blood on the rise as they deal with many patients who delayed care due to the COVID-19 pandemic
Anxiety-Related Adverse Event Clusters ID’d After Janssen Vaccine
Rate of syncope was 8.2 per 100,000 doses after Janssen COVID-19 vaccination vs 0.05 per 100,000 after flu shots
Bisphosphonates May Treat Calciphylaxis in Kidney Transplant Recipients
Moderate to severe hyperparathyroidism after kidney transplantation may have predisposed 2 cases to calciphylaxis, according to investigators.
