SPOTLIGHT -
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.
Novo Nordisk Cuts Price on Several Insulin Products by 75%
The lower prices will take effect on Jan. 1, 2024, on both pre-filled pens and vials of basal, bolus and pre-mix insulins, including Levemir, Novolin, NovoLog and NovoLog Mix 70/30.
VA to Cover the Alzheimer’s Drug Leqembi
The VA’s guidelines would exclude anyone who has had a stroke or seizure within the last year, as well as those who have MRIs that show evidence of microhemmorrhages, aneurysms, lesions or tumors.
FDA Approves First Treatment for Rett syndrome
Daybue will be available by the end of April with a list price of about $375,000 annually.
CMS Grants Aponvie Pass Through Status
Aponvie is the first intravenous version of aprepitant adults to prevent postoperative nausea and vomiting.
CMS Grants Pass-through Reimbursement for Iheezo
Iheezo, approved in September 2022, is an ocular surface anesthesia used during cataract surgeries.