Formulary Watch |

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

Mycovia Pharmaceuticals Launches Vivjoa for Chronic Yeast Infections

Vivjoa, approved by the FDA in April 2022, is an oral therapy and the first for chronic yeast infections.

BMS Updates Safety Label of Reblozyl

FDA Approves Liquid Form of Zonisamide

Zonisade is the first oral liquid form of zonisamide to be approved by the FDA to treat patients with epilepsy.

FDA Approves Xalkori for Rare Type of Tumor

Pfizer’s Xalkori is now approved for three indications, with the most recent being ALK-positive myofibroblastic tumors

UnitedHealthcare to End Copays for Some Drugs

First Patient Dosed in Trial of “Gene Editing” Medicine

Hospira Recalls One Lot of Propofol

Particulates were seen in a single vial, which could lead to blockage of blood vessels, including decreased blood flow to the brain, heart attack, and pulmonary embolus.

Analysis: Medicare Could Save Money with Mark Cuban’s Online Pharmacy

Investigators suggest that policies that improve price transparency and increase competition for generic drugs could prevent patients and Medicare from overpaying on generic drugs.

FDA Delays Decision on BeiGene’s BLA for Tislelizumab

The FDA has not been able to complete inspections of facilities because of COVID-19 restrictions.

FDA Grants EUA for Novavax COVID-19 Vaccine

Study: Breakthrough Therapies Can be Cost-Effective

FDA Approves Novel Diagnostic Dye for Endoscopy

Bludigo is the first indigotindisulfonate drug product approved by the FDA.

FDA Accepts BLA for Advanced HER2 Breast Cancer Therapy

The FDA has assigned a Prescription Drug User Fee Act action date of May 12, 2023, for [vic-]trastuzumab duocarmazine (SYD985).

Amgen Biosimilar Report: Marketplace Poised for Growth

Cell and Gene Therapies Present Challenges to Payers

Novel Psoriasis Therapy to be Submitted to FDA

Piclidenoson is a first-in-class, A3 adenosine receptor agonist small molecule that inhibits the inflammatory cytokines interleukin 17 and 23.

Cystic Fibrosis Medication Adds Significantly to Healthcare Costs