Denise Myshko

Philadelphia

Senior Editor at Formulary Watch

Contributor at Managed Healthcare Executive

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Articles

FDA Approves Dupixent for Inflammatory Skin Disease

6 days ago | managedhealthcareexecutive.com | Denise Myshko

The FDA has approved the resubmitted application of Dupixent (dupilumab) to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU). It is indicated for patients who remain symptomatic despite histamine-1 (H1) antihistamine treatment. Chronic spontaneous urticaria is a chronic inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and recurring itch.
FDA Sets Action Date for Eylea HD in Retinal Vein Occlusion

1 week ago | managedhealthcareexecutive.com | Denise Myshko

The FDA has accepted for priority review Regeneron’s supplemental biologics license application (sBLA) for Eylea HD (aflibercept) injection 8 mg. The sBLA seeks approval for Eylea HD to treat patients with macular edema following retinal vein occlusion (RVO), and for broadening the dosing schedule to include every 4-week (monthly) dosing across approved indications. The FDA's target action date is Aug.
UnitedHealth Group’s First Quarter Revenue Increases, But Company Revises Outlook

1 week ago | managedhealthcareexecutive.com | Denise Myshko

UnitedHealth Group’s first quarter 2025 revenue has grown compared with the first quarter of 2024, but the company has adjusted its performance outlook for 2025 to net earnings of $24.65 to $25.15 per share. Company leaders said in a press release that healthcare expenses, especially physician and outpatient services, within the Medicare Advantage businesses were above what they had expected.
Obesity and Use of GLP-1 Drugs are Increasing in People with Type 1 Diabetes

1 week ago | managedhealthcareexecutive.com | Denise Myshko

The use of GLP-1 receptor agonists rose in patients who have type 1 diabetes as obesity rates increased for these patients, according to a new study published online in Diabetes, Obesity and Metabolism. In the highest obesity category assessed by researchers, the proportion of adult patients using these medications increased from about 4% in the 2008 to 2011 period to about 33% in the 2020 to 2023 timeframe.
Analysis Finds Brukinsa May Provide Costs Savings Over Imbruvica in CLL

1 week ago | managedhealthcareexecutive.com | Denise Myshko

The use of Brukinsa (zanubrutinib) instead of Imbruvica (ibrutinib) as a second-line treatment for patients with chronic lymphocytic leukemia could potentially lead to fewer adverse events and result in fewer healthcare costs, according to new analysis. This analysis, using a number needed to treat (NNT) modeling method, estimated that approximately 13 patients would avoid disease progression or death over 24 months, saving about $4.7 million.
Liver Injury Ends Development of Pfizer’s Oral GLP-1 for Obesity

1 week ago | managedhealthcareexecutive.com | Denise Myshko

Pfizer has stopped clinical development of danuglipron (PF-06882961), its once-daily oral glucagon-like peptide-1 receptor agonist (GLP-1) candidate to treat obesity. Danuglipron was being studied for adults with obesity and without type 2 diabetes. Pfizer’s two dose-optimization studies of once-daily formulations of danuglipron met key pharmacokinetic objectives and confirmed a formulation and dose to be used in a phase 3 trial, according to a news release.
CEOs defend their PBMs. Don’t believe it, says a critic

1 week ago | managedhealthcareexecutive.com | Denise Myshko

At a time when Congressional efforts to reform pharmacy benefit managers (PBMs) seem to be moving forward once again — a hearing by the House Committee on Energy and Commerce was held in February 2025 to address PBM competition — the larger PBMs are fending off their critics with changes that they say improve transparency into pricing and other PBM practices and give new options to their payer clients.
FDA Approves Biocon’s Avastin Biosimilar

2 weeks ago | managedhealthcareexecutive.com | Denise Myshko

The FDA has approved the fifth biosimilar of Genentech’s Avastin (bevacizumab). Biocon Biologics' biosimilar Jobevne (bevacizumab-nwgd), like Avastin and other approved biosimilars, is a recombinant humanized monoclonal antibody used to treat several different types of cancer. Bevacizumab is a vascular endothelial growth factor (VEGF) inhibitor, which blocks blood vessel growth. It is used to treat cancers such as colorectal, lung, glioblastoma, kidney, cervical, and ovarian cancer.
Payers Consider Policy Options for Access to GLP-1 Obesity Medications

2 weeks ago | managedhealthcareexecutive.com | Denise Myshko

With up to 40% of the U.S. population potentially eligible for treatment with GLP-1 inhibitors for obesity, payers and policymakers and other experts question how they provide coverage that is affordable for patients, according to a new paper by the Institute for Clinical and Economic Review’s (ICER). “The obesity medications Wegovy and Zepbound are fairly priced from a long-term value perspective at their current estimated net price,” Sarah K.
FDA Announces Goal Date for Resubmitted Bevacizumab to Treat Wet AMD

2 weeks ago | managedhealthcareexecutive.com | Denise Myshko

The FDA has accepted the resubmission of Outlook Therapeutics’ biologics license application (BLA) for ONS-5010 (bevacizumab-vikg), an ophthalmic formulation of bevacizumab to treat patients with wet age-related macular degeneration (wet AMD). The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of Aug. 27, 2025. If approved, the therapy would be branded as Lytenava and is expected to receive 12 years of regulatory exclusivity.