Other indications for the blockbuster cancer mediation are not affected.
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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.
State officials say the new NYRx program will mean fewer restrictions and create a largest pharmacy network in the state.
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.
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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.
The suit alleges that Express Scripts, Prime and Prime customer Humana Pharmacy Solutions are able to share drug pricing and rebate information to increase prices for insulins, biologics and cancer drugs.
Out-of-pockets costs were higher among those using branded or more recently launched drugs.
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RxBenefits helps patients in self-funded plans find and apply for alternative sources of funding for specialty medicines and facilitates enrollment.
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.
The presence of a cancer-causing nitrosamine was found in the product, an oral anticoagulant to lower the risk of stroke and blood clots.
The proposed legislation, sponsored by Sens. Chuck Grassley and Maria Cantwell, aims to increase transparency of PBM business practices.
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.
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