Formulary Watch |

Study: Health Plan Design Influences Biosimilar Adoption

Optum Rx Revenue Grew 16% in 2023

FDA Finds No Link Between GLP-1 Drugs and Thoughts of Suicide

Regulators will continue to evaluate a possible link by reviewing meta-analysis of clinical trials across all GLP-1 products and analyzing postmarketing data in the Sentinel System.

Harrow Launches Vevye for Dry Eye Disease

Vevye is a water- and preservative-free solution of cyclosporine, which allows for improved bioavailability.

Brent Eberle: “Not all Cost-Plus is Created Equal"

Court Approves Rite Aid’s Sale of Elixir PBM to MedImpact

The transaction is valued at about $575 million. The sale is part of Rite Aid’s restructuring plan after filing for bankruptcy in October 2023.

FDA Assigns Review Date for Full Approval of Tivdak for Cervical Cancer

Tivdak was granted accelerated approval in September 2021 to treat patients with recurrent or metastatic cervical cancer. The goal date for full approval is May 9, 2024.

FDA Issues CRL for Zolbetuximab Biologics License Application

The FDA cited issues with a third-party manufacturing company. Zolbetuximab is being reviewed to treat patients with stomach cancer.

FDA Approves Gel for Skin Infection Caused by Poxvirus

Zelsuvmi, a first-in-class topical treatment approved for patients with molluscum contagiosum, will be available in the second half of 2024.

Drug Channels Acquired by HMP Global

Adam Fein, founder of Drug Channels, said the acquisition will allow the company to upgrade its technology, grow the company and provide live and in-person events.

FDA Accepts Accord’s BLA for Stelara Biosimilar

If approved, Accord’s biosimilar would treat several autoimmune conditions and would be launched no later than May 15, 2025

CVS Caremark to Remove Branded Humira from Formularies

UCB Launches Zilbrysq for Generalized Myasthenia Gravis

Coherus Launches Loqtorzi for Nasopharyngeal Carcinoma

Loqtorzi has a wholesale acquisition cost of $8,892.03 per single-use vial.

Glass in Vials Leads to Recall of Several Hospira Products

The presence of glass can lead to serious adverse events, including inflammation of a vein and blockage of blood vessels or life-threatening blood clots.

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FDA Approves Rare Disease Drug Wainua

Wainua is approved to treat patients with hereditary transthyretin-mediated amyloid polyneuropathy and can be self-administered via an auto-injector.

FDA and Novo Nordisk Warn about Counterfeit Ozempic

The FDA has seized thousands of units of counterfeit Ozempic 1 mg.

FDA Grants Full Approval to Tarpeyo for Rare Kidney Disease

This is the first treatment for patients with primary immunoglobulin A nephropathy to be granted full approval.

Merck Receives Complete Response Letter for Cough Drug Gefapixant

This is the second complete response letter for gefapixant, and FDA officials said the application did not provide evidence of effectiveness.

Harm Reduction Launches Naloxone Nasal Spray

Nonprescription RiVive was approved in July 2023 to reverse opioid overdose. Harm Reduction is donating 200 doses to Remedy Alliance for distribution.

New Study Planned for Bevacizumab to Treat AMD

Outlook Therapeutics plans to begin a study in the first quarter of 2024 to address the issues identified in a FDA complete response letter. If approved, Lytenava would be the only bevacizumab product to specifically treat age-related macular degeneration.

FDA Approves Topical for Rare Skin Disorder

Filsuvez treats children and adults with epidermolysis bullosa, a condition that causes the skin to blister, and junctional epidermolysis bullosa, which causes lesions in the mouth.

Lupin Gets Approval for Chantix Generic

In other generic news, the FDA has approved generics of the osteoporosis drug Forteo and Amneal is developing a generic version of Vascepa.

FDA Approves Zoryve Foam for Seborrheic Dermatitis

Zoryve foam will have the same wholesale acquisition cost as the cream version: $858 per tube.

FDA Issues Complete Response Letter for Cosibelimab in Cutaneous Squamous Cell Carcinoma

The FDA cited issues related to an inspection of Checkpoint Therapeutics’ third-party contract manufacturing organization.