FDA Grants Belantamab Mafodotin Priority Review for Myeloma
The FDA granted priority review to the biologics license application of belantamab mafodotin for the treatment of patients with relapsed or refractory multiple myeloma...
Sickle Cell Disease Gene Therapy Receives Orphan Drug Designation
ARU-1801, an investigational gene therapy for the treatment of sickle cell disease (SCD) and beta thalassemia, was granted orphan drug designation by the FDA.
ARU-1801...
BioMarin Sets High Price Tag for Hemophilia Gene Therapy Candidate
If its experimental gene therapy for patients with hemophilia A is approved by the FDA, BioMarin Pharmaceutical is considering pricing valoctocogene roxaparvovec (valrox) between...
FDA Approves Ferric Derisomaltose for Iron-Deficiency Anemia
The ferric derisomaltose injection received FDA approval for the treatment of iron-deficiency anemia in adults who are intolerant to oral iron, whose disease has...
Treatment for Lymphoplasmacytic Lymphoma Receives Orphan Designation
The FDA granted orphan drug designation to CLR 131, a phospholipid-drug conjugate that selectively delivers the radioisotope iodine-131 to tumor cells.
CLR 131 is being...
FDA Places Partial Hold on Clinical Trials of Lacutamab for Advanced T-Cell Lymphomas
The FDA has placed a partial clinical hold on the phase II TELLOMAK trial, which is evaluating the safety and efficacy of lacutamab in...
Drug Prices Increase by an Average of 5.8% for 2020
On January 1, 2020, more than 60 pharmaceutical companies raised list prices on hundreds of medications by an average of 5.8%. Nearly all price...
Study Finds Hospital Mergers Failed to Improve Quality of Care
Research published in the New England Journal of Medicine found that the recent wave of health care mergers and acquisitions had no substantial impact...
Acalabrutinib Approved for CLL Under New International Collaboration
The FDA granted a supplemental approval to acalabrutinib for the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Acalabrutinib...
Bristol-Myers Wins $752 Million From Gilead in Patent Dispute
Bristol-Myers Squibb has won a $752 million lawsuit against Gilead Sciences to settle a U.S. patent dispute regarding the chimeric antigen receptor (CAR) T-cell...
Current Issue
March 2020, Volume 6, Issue 4
This issue looks at how cost-effective analyses are used to inform health-care decisions, explains the latest maintenance of certification requirements, and more.
