Formulary Watch |

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.

PBM Ventegra Includes Avastin Biosimilar on Formulary

FDA Approves Adbry for Atopic Dermatitis in 12 to 17 Year Olds

The price for of Adbry is $1,810.87 for a two pack of syringes.

FDA Approves Welireg for Advanced Kidney Cancer

Welireg is now also indicated for patients whose renal cell carcinoma has progressed after treatment with PD-1 or PD-L1 inhibitor and a TKI therapy.

Oral Postpartum Depression Drug Zurzuvae Launches

FDA Sets Review Date for Bispecific Antibody for Solid Tumor

The FDA has set a target date of June 12, 2024, for tarlatamab to treat adult patients with advanced small cell lung cancer. If approved, it would be the first bispecific antibody for a solid tumor.

Survey Finds More than Half of Employers Not Confident in PBM Practices

Drug prices and the practices of PBMs are among the concerns expressed by employers who responded to the Pulse of the Purchaser survey by National Alliance of Healthcare Purchaser Coalitions.

MAPS Submits NDA for Psychedelic Therapy for PTSD

Optum Rx to Provide Weight Loss Management Program

Optum Rx standard formularies currently include the weight loss drugs Wegovy and Saxenda, and the PBM is evaluating Zepbound.

FDA Sets Review Date for Marstacimab to Treat Hemophilia

Marstacimab is being reviewed to prevent or reduce the frequency of bleeding episodes in people with hemophilia A or B. The FDA has set an action date in the first quarter of 2024.

ICER: Humira Among Drugs that had Unsupported Price Increases in 2022

Improper Seal Leads Cipla to Recall Vigabratrin

Cipla is recalling one lot of vigabatrin, which is used to treat seizures.

FDA Approves Two Gene Therapies for Sickle Cell Disease