Formulary Watch |

Pfizer/BioNTech COVID-19 Booster EUA Expanded to Ages 16 to 17

FDA Grants Emergency Use of AstraZeneca’s COVID-19 Prevention Med

FDA Approves Therapy for Multiple Sclerosis-Related Spasticity

The oral granules formulation allows it to be used with soft foods and with feeding tubes.

Pfizer/BioNTech’s COVID-19 Vaccine Provides Some Protection Against Omicron

Monoclonal Antibody Drug Effective Against Omicron, GSK and Vir Say

PharmaEssentia Launches Besremi for Rare Blood Disease

Besremi was approved in November to treat adults with polycythemia vera.

Amber Specialty is Chosen to Dispense Livtencity

Livtencity, manufactured by Takeda, was approved in November 2021 and is the first therapy to treat cytomegalovirus infection after transplants.

FDA Requires New Boxed Warning on Xeljanz, other JAK Inhibitors

Gilead Recalls Two Lots of COVID-19 Therapy Veklury

Glass has been detected in the two lots of Veklury, which is used to treat patients who are hospitalized with COVID-19.

Secura Bio Withdraws U.S. Oncology Indications for Copiktra, Farydak

Both Copiktra and Farydak had received accelerated approvals, and the FDA had required confirmatory trials. Secura Bio has determined such trials are not feasible.

Drug Shortages Update — December 5, 2021

Darzalex Faspro Gets New Multiple Myeloma Indication

Sandoz Recalls One Lot of Enoxaparin

A temperature change during shipping could impact the product’s effectiveness. Enoxaparin is used to prevent deep vein thrombosis.

BMS Updates Safety Label for Inrebic

FDA Accepts for Priority Review Supplemental Application of Reblozyl

The FDA is reviewing Reblozy to treat anemia in patients with beta thalassemia. The PDUFA action date is March 27, 2022.

Pharmacy Organizations Criticize CMS COVID-19 Decision

FDA Approves Vaccine for Hepatitis B

PreHevBrio is a three-antigen hepatitis B vaccine for adults in the United States. It is expected to be available in the first quarter of 2022.

Merck Submits Application for Vaxneuvance for Children, Adolescents

The FDA has set a PDUFA action date of April 1, 2022.

ICER: Fair Access to Prescription Drugs Varies Across Payers

FDA Accepts BMS Application for Psoriasis Therapy

The FDA has assigned a Prescription Drug User Fee Act goal date of Sept. 10, 2022, for deucravacitinib. If approved, it would be the first TYK2 inhibitor approved for the treatment of any disease.

Advisory Committee Recommends Authorization of the COVID-19 Anti-viral Molnupiravir

If the FDA authorizes molnupiravir, it would be the first oral anti-viral to treat COVID-19 that patients can take at home.

Study: Hospitals Charge Insurers, Cash Patients More for Drugs

The FDA Grants Priority Review for Lynparza for Early Breast Cancer

FDA Approves Imaging Agent to Detect Ovarian Cancer

Cytalux is the first imagining agent to illuminate ovarian cancer during surgery.

Study Finds Patients with Hypertension Take Drugs that Raise Blood Pressure

Merck Releases Updated Data on its COVID-19 Antiviral

Merck now says molnupiravir reduces the risk of hospitalization or death from COVID-19 by 30% after all data have been analyzed. Previously, an interim analysis showed a 50% reduction in hospitalization or death.

New COVID-19 Variant is Identified

Study: Generic Statins Led to Significant Cost Savings

FDA Pauses Clozapine REMS Program

Walgreens Offering Biosimilar and Interchangeable Insulin Semglee