Formulary Watch |

FDA Grants Priority Review for Glofitamab for Blood Cancer

Genentech’s glofitamab is a bispecific antibody being reviewed to treat adults with large B-cell lymphoma. The FDA is expected to make a decision on approval by July 1, 2023.

FDA Accepts Second UCB Application for Generalized Myasthenia Gravis

Rozanolixizumab is a monoclonal antibody that addresses a different driver of generalized myasthenia gravis. An FDA decision is expected in the second quarter of 2023.

FDA Accepts BLA for RSV Prevention in Infants

Nirsevimab is a single-dose, long-acting antibody to protect infants from respiratory syncytial virus (RSV) lower respiratory tract infections. The FDA action date is in the third quarter of 2023.

Blue Cross Organizations Launch Drug Contracting Collective

Synergie Medication Collective, which launches this month, is focused on improving affordability and access to gene therapies, infusible cancer drugs and other medications administered in a clinical setting.

Drug Makers Start 2023 With Price Hikes

Celltrion Submits BLA for New Formulation of Infliximab

CT-P13 SC is a subcutaneous formulation of Celltrion’s Inflectra, a biosimilar of Remicade. The BLA seeks approval to treat patients with inflammatory bowel disease.

Wegovy Approved for Teens; Supply May be Delayed

Glass Particles in Vial Lead to Vancomycin Recall

Hospira is calling one lot of vancomycin hydrochloride, an antibiotic to treat patients with serious infections caused by methicillin-resistant staphylococci.

Orasis Submits NDA for Blurry Vision Treatment

If approved, CSF-1 would be the second therapy to treat patients with presbyopia, or age-related blurry vision.

Regence Reduces Annual Drug Spend by $37 Million with Biosimilars

FDA Approves New Therapy for Urea Cycle Disorders

Olpruva is a new formulation of sodium phenylbutyrate to treat patients with urea cycle disorders, a genetic condition that causes ammonia to build up in the blood.

Best Read Healthcare Trend Stories in 2022

Among the best-read healthcare trend and PBM-related stories are ICER’s report on unsupported prices, fake drugs containing meth, an anti-tau drug that shows promise in Alzheimer’s, oncology docs say prior auth hurts patients, and satisfaction with PBMs declines.

FDA Clears Twice a Year Monoclonal Antibody for MS

Best Read Product Recall Stories in 2022

Among the most-read product recall stories are those of amoxicillin, metformin, sodium bicarbonate Omnipod 5, and clopidogrel and atenolol.

FDA Issues Complete Response Letter for Palovarotene

Palovarotene is a therapy for an ultra-rare disease that transforms the body’s soft tissue into bone. The FDA has requested additional information from clinical trials.

Best Read PBM News Stories in 2022

Among the most-read stories about PBMs include Transcarent and Prescryptive Health teaming up for employer pharmacy; Kroger Health ending agreement with Express Scripts; Mark Cuban Cost Plus Drugs teaming up with EmsanaRx and Vivio Health; and Abarca Health takes on a challenging implementation.

FDA Accepts Application for Nonprescription Naloxone

A decision by the FDA is expected by April 28, 2023, and, if approved, Harm Reduction Therapeutics will launch RiVive in early 2024.

Best Read Safety Articles of 2022

Among the top safety stories this year are Genentech’s warning to Ocrevus label, FDA’s update to GnRH agonists, a study about JAK-inhibitor side effects, FDA’s warning about Prolia in kidney disease and safety issues related to the potential Alzheimer’s disease drug lecanemab.

Best Read Drug Approvals Stories in 2022

Among the top-read FDA approval stories include the fast-acting Auvelity to treat major depressive disorder; an extended use for Mirena IUD; the first generic of Symbicort for asthma; Camzyos, a first-in-class treatment for obstructive hypertrophic cardiomyopathy; and Imbruvica’s expanded indication for children with chronic graft versus host disease.

FDA Approves First Bispecific Antibody for Follicular Lymphoma

Lunsumio is Genentech’s first approved T-cell engaging bispecific antibody and targets CD20 on the surface of B cells and CD3 on the surface of T cells.

Best Read Drug Coverage News in 2022

Drug coverage decisions and new offerings from OptumRx, Caremark, Cigna and Wellcare made the list of the top-read drug coverage news in 2022.

FDA Approves First-in-Class HIV-1 Treatment

ICER: Draft Review Suggests Lecanemab’s Cost-effectiveness Range of $8,500-$20,600

FDA Accepts sBLA for Padcev, Keytruda Combo for Urothelial Cancer

New Acute Myeloid Leukemia Therapy has Monthly Price of $32,200

Rezlidhia is an oral, small molecule inhibitor of mutated IDH1 that was approved by the FDA to treat patients with relapsed or refractory acute myeloid leukemia.

Impurities Lead to Lupin Recall of Quinapril

Testing of the blood pressure medication revealed nitrosamine levels that were above acceptable limits.

FDA Approves Actemra for Hospitalized Patients with COVID-19

Actemra is the first FDA-approved monoclonal antibody to treat hospitalized adults with COVID-19. The EUA for use of Actemra in children remains in place.

ICER: Monoclonal Antibodies Not Cost-Effective in Multiple Sclerosis

CAR-T Therapies Cost Prohibitive for Diffuse Large B-Cell Lymphoma Treatment

FDA Clears Tymlos for Osteoporosis in Men

Tymlos is already available to treat postmenopausal women with osteoporosis.