Christine Blank

The FDA has assigned a Prescription Drug User Fee Act action date of June 16, 2023.

The rate reflects a continued trend toward moderation of the overall increase in drug prices.

Sean Dickson of West Health Policy Center discusses Reuters' analysis of drug launch prices.

The EUA allows Jynneos to be used in children at high risk for monkeypox and as an intradermal injection, rather than subcutaneous, for adults.

A rise in the number of long COVID is sparking research efforts by the HHS, the CDC and drug companies to understand the conditions and develop treatments.

OptumRx profiles four therapies that are expecting FDA decisions in the next few months.

The bipartisan bill introduced in the Senate in May would require PBMs to report to the FTC how much money they make through spread pricing and pharmacy fees.

Next year, seven biosimilars of Humira are expected to launch, but leaders from the Biosimilars Forum are concerned not all will make it onto formularies.

The U.S. government pre-purchases 3.2 million initial doses of the Novavax COVID-19 vaccine.

The United States has acquired adult and pediatric doses of the COVID-19 vaccine for delivery in early fall in a contract worth $3.2 billion, as well as an additional 150,000 doses of bebtelovimab for about $275 million.

The FDA is accepting comments on the proposed rule through Oct. 26, 2022.

The trial was an observational study aimed at collecting real-world data on the Alzheimer’s treatment.

On June 15, 2022, the FDA’s Vaccines and Related Biological Products Advisory Committee unanimously voted in favor of both vaccines.

The committee recommended Moderna’s and Pfizer’s COVID-19 vaccines were recommended for children 6 months to five years, as well as Moderna’s vaccine for children ages 7 to 16.

Efanesoctocog alfa is a new class of factor VIII therapy with once-weekly prophylactic dosing. The application for approval expected to be filed mid year.

The recalls were made because the medications failed sterility testing.

Novavax’s COVID-19 vaccine demonstrated 90.4% efficacy with a low number of serious and severe adverse events, including myocarditis.

The Access to Oncology Medicines Coalition brings together pharma companies and other organizations to help countries develop the capacity and access to essential cancer medicines.

The FDA emergency use authorization allows the nonprescription test to use at-home sample collection with testing performed in a laboratory.

Mounjaro is a first-in-class medicine that activates both the GLP-1 and GIP receptors, which leads to improved blood sugar control.

Olumiant is the first immunomodulatory treatment for COVID-19 to receive FDA approval.

The move to limit Janssen’s vaccine comes after an analysis finds there is a risk of thrombocytopenia syndrome (TTS), a rare syndrome of blood clots and low levels of blood platelets.

The FDA’s Prescription Drug User Fee Act action date for its regulatory decision for Imfinzi for BTC is during the third quarter of 2022.

UnitedHealthcare considers Aduhelm unproven and not medically necessary for treating Alzheimer’s disease.

Lenvima is approved to treat thyroid cancer, renal cell carcinoma and in combination with Keytruda for metastatic kidney cancer.

Moderna is also studying booster doses of the COVID-19 vaccine for all pediatric cohorts.

Veklury gets full approval for use in children and the Biden Administration commits to expanding the Test-to Treat initiative and getting COVID-19 anti-virals to those who need them.

The World Health Organization now recommends Paxlovid and Veklury for non-severe COVID-19 at high risk of hospitalization but still advises against use in mild disease with low risk of hospitalization.

The FDA has granted orphan drug designation to a potential first-in-class therapy for scleroderma and a PD-1 inhibitor for small cell lung cancer.

The InspectIR Systems Breathalyzer test can provide results in three minutes.