SPOTLIGHT -
FDA Approves First Treatment for Rare Immunodeficiency Disease
Leniolisib, now with the brand name Joenja, treats APDA, a genetic disorder that impairs the immune system. It will have an annual list price of $547,500 a year.
FDA Clears First New Treatment for Invasive Candidiasis in 10 Years
Rezzayo is a novel once-weekly antifungal approved to treat invasive candidiasis, a serious infection that can affect the blood, heart and brain.
FDA Rejects NDA for Extended-Release Jakafi
Regulatory officials identified additional requirements for approval of an extended-release version of Jakafi, which is under review for myelofibrosis, polycythemia vera and graft-versus-host disease.
Impurities Lead to Recall of 10 Lots of Dabigatran
The presence of a cancer-causing nitrosamine was found in the product, an oral anticoagulant to lower the risk of stroke and blood clots.
Committee Sends PBM Transparency Bill to Full Senate
The proposed legislation, sponsored by Sens. Chuck Grassley and Maria Cantwell, aims to increase transparency of PBM business practices.
FDA Grants Accelerated Approval to Zynyz for Merkel Cell Carcinoma
Zynyx will be priced comparable to other PD-1 inhibitors currently available to treat metastatic or recurrent locally advanced Merkel cell carcinoma, a rare skin cancer.
California Selects Generic Company Civica Rx as Insulin Partner
CalRx will work with Civica to provide the most commonly used short- and long-acting insulins at planned prices of no more than $30 a vial and $55 for a box of five pre-filled pens.
Hyrimoz, a High-Concentration Humira Biosimilar, Approved by FDA
Sandoz will now launch both high-concentration and low-concentration versions of Hyrimoz (adalimumab-adaz) in July.
FDA Wants More Information about AbbVie’s Parkinson’s Therapy
In a complete response letter, the FDA has requested information about the pump that will be used to deliver ABBV-951, which will provide continuous subcutaneous delivery of oral immediate-release carbidopa/levodopa.
FDA Extends Evkeeza Indication to Include Young Children
Evkeeza treats a rare form of high cholesterol. It is now approved for patients as young of 5 years of age.
Sanofi Slashes Lantus List Price by 78%
The company also will establish a $35 cap on out-of-pocket costs for Lantus for all patients with commercial insurance.
FDA Expands Illuccix Label to Identify Patients for Treatment with Pluvicto
Illuccix is for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.
Hemophilia Groups Protest BCBS of Tennessee Formulary Exclusions
The patient groups say the insurer is cutting off access to important medications. The Tennessee Blues plans say many of the drugs that it excluded from coverage have zero utilization.
HHS Names 27 Drugs Subject to Medicare Inflation Rebates
Medicare Part B beneficiaries are expected to save between $2 and $390 per average dose starting April 1, 2023.
Bacterial Contamination Leads to Recall of Antifungal Drug
Atovaquone Oral Suspension, which treats AIDS-related pneumonia, is being called because of the potential of Bacillus cereus contamination that could lead to life-threatening infections.