Sandoz is seeking approval for a high-concentration formulation of Hyrimoz, which references AbbVie’s Humira.
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The KEYNOTE-412 study did not meet its primary endpoint of event-free survival.
Pegcetacoplan is a targeted therapy to treat patients with age-related macular degeneration. The Prescription Drug User Fee Act (PDUFA) target action date is Nov. 26, 2022.
An independent data monitoring committee made the recommendation to stop both arms of the trial after a planned interim analysis found the trial didn’t meet its objectives.
Navitus senior vice president and chief pharmacy officer Brent Eberle talks about how partnering with CivicaScript fits into its cost-plus model.
If approved, this would be the first therapy to treat patients with Rett syndrome, a rare genetic neurological disorder mostly in girls.
Opzelura is first therapy approved to treat patients with vitiligo, a disease that causes the loss of skin color.
Vivjoa, approved by the FDA in April 2022, is an oral therapy and the first for chronic yeast infections.
BMS warns about the risk of extramedullary hematopoiesis, a rare complication in which the production of blood cells occurs outside of the bone marrow.
Zonisade is the first oral liquid form of zonisamide to be approved by the FDA to treat patients with epilepsy.
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Pfizer’s Xalkori is now approved for three indications, with the most recent being ALK-positive myofibroblastic tumors
Some insulins, as well as some drugs used in emergency care, will now be offered at $0 copay for eligible patients.
A novel therapy in early development aims to permanently turn off the PCSK9 gene in the liver and lower cholesterol with a one-time treatment. It is being developed for a genetic form of high cholesterol.
Particulates were seen in a single vial, which could lead to blockage of blood vessels, including decreased blood flow to the brain, heart attack, and pulmonary embolus.
Investigators suggest that policies that improve price transparency and increase competition for generic drugs could prevent patients and Medicare from overpaying on generic drugs.
The FDA has not been able to complete inspections of facilities because of COVID-19 restrictions.
The U.S. government pre-purchases 3.2 million initial doses of the Novavax COVID-19 vaccine.
Drugs approved with an FDA breakthrough designation can provide value that offsets their higher costs, finds study conducted by Tufts Center for the Evaluation of Value and Risk in Health.
Bludigo is the first indigotindisulfonate drug product approved by the FDA.
The FDA has assigned a Prescription Drug User Fee Act action date of May 12, 2023, for [vic-]trastuzumab duocarmazine (SYD985).
In 2023, a wave of biosimilar launches is expected, including seven biosimilars of Humira.
In the future, payers plan to leverage reinsurance and value- or outcomes-based contracting to provide access to high-cost therapies.
Piclidenoson is a first-in-class, A3 adenosine receptor agonist small molecule that inhibits the inflammatory cytokines interleukin 17 and 23.
Blue Cross Blue Shield of North Carolina found that uptake of Trikafta was rapid after approval and total cost of care increased 52% despite reductions in hospitalizations and nonpharmacy costs.
The FDA approved a supplemental BLA for use of Krystexxa with methotrexate for the treatment of uncontrolled gout.
This is the second batch to be recalled because of the potential of missing labels.
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