Formulary Watch |

Senate Passes Bill that Caps Insulin at $35 for Medicare Beneficiaries

FDA Approves Tablet Form of Calquence

The tablet form has the same safety and efficacy as the capsule formulation and allows it to be administered with gastric-reducing therapies.

FDA Approves Enhertu for HER2 Low Breast Cancer

This is the first approved therapy targeted to patients with the HER2-low breast cancer subtype. Its approval comes four months ahead of its PDUFA action date.

FDA Schedules Second Advisory Committee Meeting for AMX0035 in ALS

The committee will meet on Sept. 7, 2022, to discuss additional analyses of data from the Amylyx’s clinical studies. The updated PDUFA goal date is Sept. 29, 2022.

FDA Issues Complete Response Letter for Nuplazid in Alzheimer’s Psychosis

FDA Accepts BLA for Biosimilar of Actemra

Fresenius Kabi expects to receive FDA approval for its tocilizumab biosimilar in 2023 and is seeking approval in both intravenous and subcutaneous administration.

Pfizer Discontinues Late-Stage Cardiomyopathy Trial

Results indicated the trial is unlikely to meet its primary endpoint, the change from baseline in the six-minute walk test at 24 weeks.

CDC Adds Diagnosis Code for Rare Primary Immunodeficiency

The new code, effective Oct. 1, 2022, allows APDS to be recognized as an distinct immunological disease.

Keytruda/Lenvima Combo Fails in Liver Cancer Trial

This is the second trial in less than a month studying Keytruda that failed to meet endpoints.

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.