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Tirzepatide was associated with a greater reduction in hemoglobin A1c and body weight versus semaglutide. Though, with a current list price of $1,023 for a one-month supply of tirzepatide (Mounjaro; Lilly), is it worth it?

This case and a case in Washington state are likely to be appealed to the Supreme Court.

Issued jointly by the FDA Commissioner and Chief Scientist, the decision means Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce. At the same time, the agency “recognizes that there is a supply of product that has already been distributed.”

The FDA granted the EUA based on the PANAMO phase 3 clinical trial results demonstrating that vilobelimab improved survival compared to placebo, with a 23.9% relative reduction in all-cause mortality at 28 days.

The combination of Padcev with Merck’s Keytruda has a potentially large market: approximately 8,000 to 9,000 U.S. patients would be eligible for this combination in the U.S.

A study funded by Genentech showed that the assistance programs substantially reduce prescription abandonment regardless of race or income level.

The new feature automatically applies manufacturer-sponsored coupons directly to an eligible patient’s order. So far, just a few pharma companies have made their coupons available through Amazon.

A bipartisan Senate bill, Affordable Insulin Now Act of 2023, would require plans to cover insulin for no more than $35 per month.

Members of the Senate Finance Committee want to modernize the rules around PBM business practices to lower out-of-pocket costs and increase competition.

Emergent BioSolutions hasn’t provided a price for the nonprescription Narcan but said the product will be available by late summer.

If approved, Perrigo’s Opill could be the first-ever nonprescription birth control pill.

Leniolisib, now with the brand name Joenja, treats APDA, a genetic disorder that impairs the immune system. It will have an annual list price of $547,500 a year.

Rezzayo is a novel once-weekly antifungal approved to treat invasive candidiasis, a serious infection that can affect the blood, heart and brain.

Regulatory officials identified additional requirements for approval of an extended-release version of Jakafi, which is under review for myelofibrosis, polycythemia vera and graft-versus-host disease.

Zynyx will be priced comparable to other PD-1 inhibitors currently available to treat metastatic or recurrent locally advanced Merkel cell carcinoma, a rare skin cancer.

CalRx will work with Civica to provide the most commonly used short- and long-acting insulins at planned prices of no more than $30 a vial and $55 for a box of five pre-filled pens.

Sandoz will now launch both high-concentration and low-concentration versions of Hyrimoz (adalimumab-adaz) in July.

In a complete response letter, the FDA has requested information about the pump that will be used to deliver ABBV-951, which will provide continuous subcutaneous delivery of oral immediate-release carbidopa/levodopa.

Evkeeza treats a rare form of high cholesterol. It is now approved for patients as young of 5 years of age.

Illuccix is for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.

Daybue will be available by the end of April with a list price of about $375,000 annually.

Zavzpret is the first calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray approved for patients with acute migraine.

Other news includes the launches of the first generic of an ulcer drug, the antipsychotic lurasidone, an extended-release version of topiramate for migraine, and additional strengths of the cancer drug lenalidomide. Additionally, Glenmark will distribute Cediprof's generic Adderall, and the FDA has accepted Amneal’s application for a generic naloxone nasal spray.

If approved, Jardiance would be the first SGLT2 inhibitor indicated for this population. A decision is expected in the second quarter of 2023.

Voxzogo is already available to treat patients older than five years with a genetic cause of dwarfism. The FDA has set a PDUFA of Oct. 21, 2023, for children younger than 5.

If approved, berdazimer could be the first prescription product treat molluscum, a common skin infection caused by poxvirus. The Prescription Drug User Fee Act goal date is Jan. 5, 2024.

With a Prescription Drug User Fee Act action date of Dec. 22, 2023, eplontersen is an antisense medicine to treat patients living with hereditary transthyretin-mediated amyloid polyneuropathy, which results in nerve damage.

The agency has set a new PDUFA target action date of June 30, 2023, for Roctavian. If approved, it would be the first one-time gene therapy for hemophilia. A.

The FDA plans to hold an advisory committee meeting to discuss the Alzheimer’s therapy. The agency has assigned Prescription Drug User Fee Act target action of July 6, 2023.

Shigella cause an estimated 450,000 infections in the United States each year and an estimated $93 million in direct medical costs.