Formulary Watch |

Prime Therapeutics Drops Two Drugs from Medicare Formularies

The changes were made because generics are now available; the change impacts specific client formularies.

Amoxicillin in Shortage Due to Increased Demand

FDA Approves Hepatitis B Therapy for Adolescents

This approval expands the use of Vemlidy to children 12 years of age and older. Vemlidy is already available for adults living with this chronic liver disease.

Accelerated Approval and the Tension Between Safety and Access

FDA Grants Priority Review for Adult RSV Vaccine

If approved, GSK’s vaccine could be the first available to help protect adults over the age of 60. The Prescription Drug User Fee Act date is May 3, 2023.

Study: PBMs’ Reimbursement Puts Pharmacies at Risk

CytoDyn Withdraws BLA for HIV Therapy

The withdrawal is related to the quality of the data collection and monitoring of the pivotal clinical trials by the clinical research organization.

FDA Again Extends Review for Pompe Disease Therapy

The FDA cited COVID-19-related travel restrictions that have impacted the agency’s inspection of a manufacturing site in China.

Paxlovid Has Hospitalization, Mortality Benefits Among the Vaccinated

Genmab Submits Applications for Bispecific Therapy for Large B-cell Lymphoma

Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells

Glass in a Vial Leads to Recall of One Lot of Octreotide

Administration of a solution containing glass could lead to irritation or swelling, vasculitis/phlebitis, allergic reactions, and pulmonary embolism.

Impurities Lead to Recall of Two Lots of Quinapril/Hydrochlorothiazide

The recall was triggered by the presence of nitrosamine above the proposed limit.

Centene Selects Express Scripts to Administer Pharmacy Benefits

Digital Health Assistant Company Offers Generics for $25 Monthly Subscription

FDA Postpones Advisory Committee Meeting for OTC Birth Control

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

Updated: FDA Approves First Bispecific Antibody for Multiple Myeloma

Tecvayli targets BCMA and CD3 to activate the body’s immune system. It was approved for heavily pretreated patients with relapsed or refractory multiple myeloma.

FDA Grants Priority Review for Novel C. Difficile Therapeutic

If approved, SER-109 would be the first oral microbiome therapeutic available. The Prescription Drug User Fee Act action date is April 26, 2023.

PSG Survey: Payer Satisfaction with PBMs Declines

FDA Grants Priority Review for Acute Myeloid Leukemia Drug

Quizartinib, which is under review to treat adult patients with newly diagnosed acute myeloid leukemia who are FLT3-ITD positive, has a Prescription Drug User Fee Act date (PDUFA) of April 24, 2023.

FDA Clears Novel Liver Cancer Combo Treatment

FDA Accepts NDA for Novaliq’s New Dry Eye Therapy

Novaliq’s CyclASol uses the EyeSol technology that allows for improved bioavailability and better efficacy. The PDUFA target action date set by the FDA is June 8, 2023.

FDA Accepts Supplemental Application for Camzyos

The FDA has assigned a PDUFA goal date of June 16, 2023, for an expanded indication to reduce the need for septal reduction therapy (SRT), which is a procedure to treat hypertrophic cardiomyopathy.

FDA Grants Six Months Pediatric Exclusivity for Eylea

Eylea is being reviewed as a treatment for retinopathy in premature infants.

Mark Cuban’s Pharmacy and Vivio Team up to Manage Specialty Drugs

The arrangement allows Vivio customers to stop overpaying for drugs, the company said.

Drugs and Older Age: An Increasingly Deadly Combination

Novavax COVID-19 Vaccine Booster Gets FDA EUA

Up, Up and Not Going Away: Cancer Drug Prices

Cigna Removes Brands in Favor of Generics for 2023

OptumRx’s Top Pipeline Drugs to Watch This Fall

FDA Extends Review Time for Biogen’s ALS Therapy

If approved, tofersen will be the first treatment that targets a genetic cause of ALS. The updated PDUFA date is April 25, 2023.