The Trump administration is reviewing the text of a final rule that would require pharmaceutical companies to disclose drug prices in television advertisements. The proposal is part of the administration's efforts to lower prescription drug prices.
A supplemental marketing application was submitted by Johnson & Johnson unit Janssen Pharmaceutica in Europe for the use of Darzalex, or daratumumab, in combination with Celgene's Revlimid, or lenalidomide, and dexamethasone as a treatment for patients with multiple myeloma who cannot be treated with autologous stem cell transplants or high-dose chemotherapy.
Sanofi and Lexicon Pharmaceuticals' new drug application for Zynquista, or sotagliflozin, to treat type 1 diabetes in adult patients in combination with insulin, has received a complete response letter. Previously, an FDA advisory committee noted that a late-stage trial showed a "consistent and clinically meaningful increase" in the risk of diabetic ketoacidosis associated with the therapy.
Enzyvant's Farber disease drug candidate RVT-801 was given fast-track and rare pediatric disease designations by the FDA.
A recall was issued by Henry Avocado for California avocados after products at its Escondido plant tested positive for Listeria monocytogenes. The recalled avocados were distributed to retail locations in Arizona, Florida, California, New Hampshire, North Carolina and Wisconsin.
Viral vector manufacturer Brammer Bio will be acquired by Thermo Fisher Scientific for about $1.7 billion. The deal would expand Thermo's capacity to create cell and gene therapies, increasing its ability to serve biotech and pharmaceutical customers.
The National Comprehensive Cancer Network has updated the guidelines on the use of non-small cell lung cancer immunotherapies, saying pembrolizumab is the preferred immune checkpoint inhibitor for patients in whom 50% or more of tumor cells express PD-L1. The guidelines also include the use of carboplatin, paclitaxel or nab-paclitaxel, and pembrolizumab for patients with squamous NSCLC; carboplatin, pemetrexed and pembrolizumab for nonsquamous tumors; and carboplatin, paclitaxel, bevacizumab and atezolizumab for patients with nonsquamous NSCLC and less than 50% PD-L1 expression.
Bluebird Bio opened a manufacturing facility in Durham, N.C., to produce lentiviral vectors for its gene and cell therapies, including bb2121 and bb21217 for patients with multiple myeloma and possibly LentiGlobin for transfusion-dependent beta-thalassemia and sickle cell disease indications.
- Page 1