Brand & Product Security

Articles

BST02 is a novel cell-based immunotherapy currently being evaluated in a Phase I trial for the treatment of all types of liver cancer.

FDA Grants Fast Track Designation to Tumor-Infiltrating Lymphocyte Therapy for Liver Cancer

Duplicate rebates have resulted in revenue leakage for manufacturers.

The Impact of 340B on Commercial Contracts

A look at the challenges that need to be addressed during the FDA stabilization period.

DSCSA 2024 or 2023 Déjà Vu?

FDA to evaluate Darzalex Faspro with bortezomib, lenalidomide, and dexamethasone for induction and consolidation treatment and with lenalidomide  for the maintenance treatment of adults newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant.

Johnson & Johnson Files sBLA for Darzalex Faspro Combination in Multiple Myeloma 

FDA to evaluate Padcev (enfortumab vedotin) with Merck’s Keytruda (pembrolizumab) for the first-line treatment of adults with previously untreated locally advanced or metastatic urothelial cancer. 

Approval Sought for Keytruda/Padcev Combination for First-Line Treatment of Urothelial Cancer 

New England Journal of Medicine study provides a breakdown of how hospitals—especially those that qualify for discounts under the federal 340B Drug Pricing Program—are able to make a profit off insurer pharmaceutical expenditures. 

A Behind-the-Scenes Look at Drug Price Markups 

Breyanzi is a CD19-directed CAR T-cell therapy approved to treat multiple hematologic cancers.

FDA Grants Priority Review to Pair of Applications for Breyanzi for R/R Follicular Lymphoma, Mantle Cell Lymphoma

Gammagard Liquid is now FDA-approved to treat neuromuscular disability and impairment in adults with CIDP; as a replacement treatment for primary immunodeficiency in patients aged 2 years and older; and as a maintenance treatment to improve muscle strength and disability in adults with multifocal motor neuropathy.

Gammagard Liquid Gets FDA Approval for Chronic Inflammatory Demyelinating Polyneuropathy 

Cohort study aims to determine whether or not these regulatory changes in state government have helped reverse opioid mortality rates. 

The Association Between Cannabis Legalization and Opioid Overdoses

Trial data show Enhertu produced clinically meaningful and durable responses for a survival benefit in patients previously administered treatment for HER2-expressing metastatic solid tumors.

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