Formulary Watch |

Top 4 Drugs to Watch in the Third Quarter

FDA Approves First Interchangeable Biosimilar to Lucentis

Analysis Confirms High Costs Impact Adherence to Cancer Drugs

Prime Therapeutics Updates Medicare Formularies

FDA Approves Stelara in Children with Psoriatic Arthritis

Stelara is the first biologic targeting both cytokines IL-12 and IL-23 and offers a therapeutic option for children six years of age and older living with active psoriatic arthritis, a rare disease.

Optum to Offer $35 Insulin to Those without Insurance

FDA Approves Steroid-Free Zoryve for Plaque Psoriasis

Zoryve, the first topical PDE4 inhibitor approved to treat patients with plaque psoriasis, will be available by mid-August.

Dr. Reddy’s Launches Prescription and Nonprescription Generics

The prescription drug launches include a therapy to treat adults with multiple myeloma and a treatment for overactive bladder. Dr. Reddy’s has also acquired several therapies from Eton Pharmaceuticals, including hypotension treatments.

Opdivo/Yervoy Combo Fails in Renal Cancer Trial

The trial of the immunotherapy combination, although approved in other renal cell carcinoma indications, did not meet the endpoint of disease-free survival in patients with localized disease.

FDA Accepts BLA for Immunotherapy for Bladder Cancer

If approved, N-803 — with the brand name Anktiva — plus the Bacillus Calmette-Guérin vaccine would be the first immunotherapy combination for this indication in 23 years. The Prescription Drug User Fee Act target action date is May 23, 2023.

Marinus Launches Ztalmy for Rare Seizure Disorder

Orsini Specialty Pharmacy has been chosen as the exclusive pharmacy provider of Ztalmy.

Groups Urge Vote on Pharmacy Benefit Manager Transparency Act

FDA Approves Benlysta for Children 5 Years and Up

Benlysta is now the only biologic approved for adults and children who have lupus or lupus nephritis, an inflammation of the kidneys.

Survey: Consumers Want More Transparency about Drug Quality

FDA Gives Okay for Bracco to Import Contrast Medium

AbbVie Submits Supplemental Applications for Rinvoq

AbbVie is seeking approval in the United States and Europe for Rinvoq to treat patients with Crohn’s disease.

FDA Accepts BLA for Tysabri Biosimilar

If approved, Sandoz’ natalizumab would be the first biosimilar of Tysabri to treat patients with multiple sclerosis.

How will the Humira Biosimilars be Covered?

FDA Accepts NDA for Therapy for Genetic Form of ALS

If approved, tofersen will be the first treatment that targets a genetic cause of ALS. The FDA assigned a Prescription Drug User Fee Act action date of Jan. 25, 2023, but said it will hold an advisory committee meeting for this application.

FDA Accepts sBLA for Enhertu in Low HER2 Breast Cancer

If approved, Enhertu would offer a treatment option for patients with breast cancer who have a lower expression of HER2. The PDUFA action date is during the fourth quarter of the 2022.

Express Scripts Updates National Preferred Formulary

Many products added to the Express Scripts preferred drug list include prior authorization and other utilization management tools.

Prime Therapeutics Reduces Opioid Claims with Targeted Intervention

AIDS Healthcare Foundation Sues Express Scripts

FDA Accepts sBLA for the Biosimilar Hyrimoz

Sandoz is seeking approval for a high-concentration formulation of Hyrimoz, which references AbbVie’s Humira.

Keytruda Fails in Phase 3 Trial for Head and Neck Cancer

The KEYNOTE-412 study did not meet its primary endpoint of event-free survival.

FDA Accepts NDA for Pegcetacoplan for Advanced Macular Degeneration

Pegcetacoplan is a targeted therapy to treat patients with age-related macular degeneration. The Prescription Drug User Fee Act (PDUFA) target action date is Nov. 26, 2022.

Merck, AstraZeneca Stop Trial of Lynparza in Colorectal Cancer

An independent data monitoring committee made the recommendation to stop both arms of the trial after a planned interim analysis found the trial didn’t meet its objectives.

Navitus Health Solutions Teams up with CivicaScript

Acadia Submits NDA for Trofinetide

If approved, this would be the first therapy to treat patients with Rett syndrome, a rare genetic neurological disorder mostly in girls.

FDA Approves Opzelura for Skin Condition