If approved, datopotamab deruxtecan would be the first TROP2-directed antibody drug conjugate to treat patients with non-small cell lung cancer. The FDA’s action date is in the fourth quarter of 2024.
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Amtagvi was approved to treat patients with advanced melanoma. It is a one-time cell therapy that will be administered at authorized treatment centers and have a wholesale acquisition cost of $515,000.
The FDA has set a PDUFA date of June 21, 2024, to convert the accelerated approval to full approval and expand the labeling of the gene therapy Elevidys beyond the current use in children aged 4 and 5 with Duchenne muscular dystrophy.
Rebates, falling prices, and rebate walls, where drug manufacturers agree to a certain price in exchange for an exclusive contract with payers, limit competition and create a dynamic of misaligned incentives.
Regulators have a set a date of June 15, 2024, to review new indication for Augtyro, which is already available to treat lung cancer with ROS1-positive lung and has a list price of $29,000 for a 30-day supply.
Onivyde is also approved to treat patients with metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy.
Rocket’s application for Kresladi is being extended by three months for regulators to review additional information submitted at the request of the FDA. The new Prescription Drug User Fee Act (PDUFA) date is now June 30, 2024.
The Inflation Reduction Act has helped to close some of the gaps in insurance coverage for vaccines, including some of the newly approved ones.
Voquezna is a potassium-competitive acid blocker, which has a mechanism similar to proton pump inhibitors but with a more rapid action. It has a list price of $650 for a 30-count bottle.
Eohilia is a liquid formulation of budesonide that will be available by the end of February. It will have a wholesale acquisition cost of $1,875 per month.
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The FDA has set a Prescription Drug User Fee Act target action date of Aug. 14, 2024, for seladelpar to treat adults with primary biliary cholangitis.
The FDA has set a Prescription Drug User Fee Act date of Aug. 10, 2024, for Human Acellular Vessel to repair arteries in patients with extremity vascular trauma.
The FDA had issued a complete response letter (CRL) in July 2023 for IPX203 and asked for additional pharmacokinetic data of carbidopa, one of the drugs the oral, extended release therapy.
In three states — California, Florida, and Texas — more than 100,000 Part D enrollees exceeded $2,000 in spending on prescription drugs in 2021, finds a new analysis from KFF.
CVS’s Health Services segment — which includes its PBM CVS Caremark — now accounts for more than half of CVS’s total revenue.
Although HHS is no longer managing the distribution of COVID-19 drugs, Secretary Xavier Becerra has been closely monitoring distribution of the antivirals Paxlovid and Lagevrio.
Although most older adults support Medicare coverage of medications for weight loss drugs, only one in three favor paying more in premiums for this coverage, finds University of Michigan survey.
The Prescription Drug User Fee Act date is June 7, 2024, for the additional indication of preventing respiratory syncytial virus (RSV) in adults aged 50 to 59 who are at increased risk. It is already approved for those over the age of 60.
The FDA has set an action date of Nov. 29, 2024, to review acoramidis to treat patients with transthyretin amyloid cardiomyopathy.
The Oncologic Drugs Advisory Committee will meet on March 15, 2024, to review overall survival data for Abecma in earlier lines of treatment in relapsed or refractory multiple myeloma.
The bulk of Cigna’s $195.3 billion 2023 revenue comes from Evernorth. And Cigna is positioning itself to grow Evernorth even more.
The sale, valued at about $576.5 million, is part of Rite Aid’s restructuring plan after filing for bankruptcy in October 2023.
New research finds that in 2022, U.S. prices across all drugs were almost three times higher than in other countries.
Biogen will focus its resources on Leqembi and research of other treatments for Alzheimer’s disease.
Defender Pharmaceuticals is working with U.S. Naval Medical Research Unit and NASA to develop intranasal scopolamine for use in military personnel and astronauts.
Bristol Myers Squibb is seeking approval of Breyanzi, a CD19-directed CAR T-cell therapy, to treat patients with follicular lymphoma and mantle cell lymphoma.
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