Formulary Watch |

Formulary Watch covers formularies, pharmacy benefit management companies, drug approvals, and other matters related to medications, their prices and insurance coverage.

Editorial Contact: Denise Myshko: dmyshko@mjhlifesciences.com

Latest News

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FDA Sets Goal Date for Lymphoma Drug Columvi
FDA Sets Goal Date for Lymphoma Drug Columvi
December 5, 2024
The combination of Columvi, gemcitabine and oxaliplatin is the first CD20xCD3 bispecific antibody to show positive results in a randomized diffuse large B-cell lymphoma phase 3 trial. The FDA’s decision is expected by July 20, 2025.

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Biden Proposes Rule to Allow Medicare, Medicaid to Cover Antiobesity Drugs
Biden Proposes Rule to Allow Medicare, Medicaid to Cover Antiobesity Drugs
November 26, 2024
Whether this proposed rule actually has any impact remains to be seen, especially with a new administration led by Donald Trump’s new health appointees.
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FDA Approves New Imatinib Oral Solution
FDA Approves New Imatinib Oral Solution
November 25, 2024
Imkeldi is a new formulation of imatinib approved as a strawberry-flavored, shelf-stable liquid designed to be more appealing to a wider range of patients, pediatric patients included.
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FDA Approves Attruby for Heart Failure Indication
FDA Approves Attruby for Heart Failure Indication
November 25, 2024
Attruby (acoramidis) is a small molecule approved to treat adults with transthyretin amyloid cardiomyopathy. It will have a list price of $18,759 for a month’s supply.
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CVS Caremark Makes Changes in Diabetes Coverage for 2025
CVS Caremark Makes Changes in Diabetes Coverage for 2025
November 25, 2024
CVS Caremark has removed several diabetes drugs favor of newer products and generics, and is even favoring an insulin infusion system developed by a company that was cofounded by Alan Lotvin, a former executive at CVS Health.
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FDA Approves Biliary Tract Cancer Antibody Treatment
FDA Approves Biliary Tract Cancer Antibody Treatment
November 21, 2024
Produced in Chinese hamster ovary cells, Ziihera (zanidatamab-hrii) is the first HER2-targeted bispecific antibody treatment for patients with previously treated, unresectable or metastatic biliary tract cancer.
FDA Clears Phase 2 Trial of Cannabis in PTSD
FDA Clears Phase 2 Trial of Cannabis in PTSD
FDA Clears Phase 2 Trial of Cannabis in PTSD
November 20, 2024
After a three-year negotiation, the FDA has dropped its objection to allowing patients to self-titrate dosing of smoked cannabis. But regulators want to see additional information about the device that will be used for inhalation.
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FDA Approves Bimzelx for Inflammatory Skin Disease
FDA Approves Bimzelx for Inflammatory Skin Disease
November 20, 2024
The FDA has approved UCB's Bimzelx for moderate-to-severe hidradenitis suppurativa, offering a new treatment option for this painful autoimmune skin disease.
Endo Recalls 16 Lots of Clonazepam Due to Mislabeling
Endo Recalls 16 Lots of Clonazepam Due to Mislabeling
Endo Recalls 16 Lots of Clonazepam Due to Mislabeling
November 19, 2024
A total of 17 lots are now part of the recall of Clonazepam because some cartons have the wrong strength on the label.
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FDA Approves First-in-Class Drug for Rare Leukemia
FDA Approves First-in-Class Drug for Rare Leukemia
November 18, 2024
Relapsed or refractory acute leukemia with a KMT2A translocation currently has an overall survival rate of less than one year when treated with frontline therapies.
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FDA Sets Review Date for Resubmitted Reproxalap in Dry Eye Disease
FDA Sets Review Date for Resubmitted Reproxalap in Dry Eye Disease
November 18, 2024
The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of April 2, 2025, for reproxalap for patients with dry eye disease. Reproxalap also is being tested in allergic conjunctivitis.
VA Adds Cancer Immunotherapy Monjuvi to National Formulary
VA Adds Cancer Immunotherapy Monjuvi to National Formulary
VA Adds Cancer Immunotherapy Monjuvi to National Formulary
November 15, 2024
Monjuvi is available under an accelerated approval to treat adults with relapsed or refractory diffuse large B-cell lymphoma.
FDA Sets Date For Resubmitted Dupixent in Inflammatory Skin Disease
FDA Sets Date For Resubmitted Dupixent in Inflammatory Skin Disease
FDA Sets Date For Resubmitted Dupixent in Inflammatory Skin Disease
November 15, 2024
The FDA has provided a date of April 18, 2025, to review the application for Dupixent to treat patients with chronic spontaneous urticaria, an inflammatory skin disease.
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AstraZeneca, Daiichi Sankyo Submit New BLA for Datopotamab in Lung Cancer
AstraZeneca, Daiichi Sankyo Submit New BLA for Datopotamab in Lung Cancer
November 12, 2024
After feedback from the FDA, the companies have voluntarily withdrawn the previous biologics licensing application for datopotamab deruxtecan for patients with advanced or metastatic nonsquamous non-small cell lung cancer.
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Many Americans Unable to Afford Medications, Navitus Survey Finds
Many Americans Unable to Afford Medications, Navitus Survey Finds
November 12, 2024
Almost half of those surveyed by Navitus Health Solutions said they’ve been unable to fill a needed prescription because of cost.
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Updated: FDA Approves Aucatzyl for Adults with Aggressive Leukemia
Updated: FDA Approves Aucatzyl for Adults with Aggressive Leukemia
November 11, 2024
Aucatzyl is a CAR T-cell therapy that targets CD19 and has been designed to minimize excessive activation of the programmed T cells. The wholesale acquisition cost is $525,000
Skyrizi Overtakes Humira in U.S. Sales Numbers
Skyrizi Overtakes Humira in U.S. Sales Numbers
Skyrizi Overtakes Humira in U.S. Sales Numbers
November 8, 2024
For the first time, Skyrizi has replaced Humira as AbbVie’s sales driver, largely due to companies encouraging “product hopping” to avoid competition, creating concerns for the sustainability of the burgeoning adalimumab biosimilar market.
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FDA Suggests Removing Nonprescription Decongestant from Market
FDA Suggests Removing Nonprescription Decongestant from Market
November 7, 2024
An FDA advisory committee last year agreed that the data do not support phenylephrine as an effective nasal decongestant.
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FDA Sets Goal Date for Donidalorsen in HAE
FDA Sets Goal Date for Donidalorsen in HAE
November 4, 2024
If approved, donidalorsen would be a first-in-class RNA-targeted medicine for hereditary angioedema. The agency’s goal date is August 21, 2025.
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Semaglutide Improves Liver Fibrosis in New Trial Analysis
Semaglutide Improves Liver Fibrosis in New Trial Analysis
November 4, 2024
In the ESSENCE trial, semaglutide improved liver fibrosis in patients with metabolic dysfunction-associated steatohepatitis (MASH).
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FDA Advisory Committee Votes Down Sotagliflozin in Type 1 Diabetes and CKD
FDA Advisory Committee Votes Down Sotagliflozin in Type 1 Diabetes and CKD
November 1, 2024
Committee members said there was uncertainty around sotagliflozin in patients with kidney disease. The FDA is currently reviewing the oral therapy as an adjunct to insulin to help control glycemic levels in adults with type 1 diabetes and chronic kidney disease. The agency’s goal date is Dec. 20, 2024.
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ICER Gives Cell Therapy for Post-Transplant Complications High Rating
ICER Gives Cell Therapy for Post-Transplant Complications High Rating
October 31, 2024
ICER has given tabelecleucel a rating of A, indicating the T cell therapy for Epstein-Barr virus related post-transplant lymphoproliferative disease has a high certainty of substantial net health benefit and would be cost-effective if priced between $143,900 and $273,700.
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FDA Grants Accelerated Approval of Scemblix for Newly-Diagnosed CML
FDA Grants Accelerated Approval of Scemblix for Newly-Diagnosed CML
October 30, 2024
Scemblix (asciminib) is a new first-line option for adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP).
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FDA Accepts Organon’s Application for Prolia Biosimilar
FDA Accepts Organon’s Application for Prolia Biosimilar
October 30, 2024
Regulators are also reviewing Teva’s application for its Prolia biosimilar candidate. The FDA’s decisions are expected mid-year 2025.
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FDA Accepts Resubmission of Translarna NDA for Duchenne
FDA Accepts Resubmission of Translarna NDA for Duchenne
October 30, 2024
PTC Therapeutics' NDA resubmission of Translarna was based on data from Study 041 and the long-term STRIDE registry. No PDUFA action date was provided for regulators.
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