Politics and Policy

The FDA would not issue an emergency use authorization for Eiger BioPharmaceuticals’ peginterferon lambda to treat patients with mild-to-moderate COVID-19.

If approved, NOV03 would be the first prescription eye drop to address excessive tear evaporation. The FDA has assigned a PDUFA action date of June 28, 2023.

A phase 3 trial showed that Imfinzi in combination with chemotherapy reduced the risk of death by 20% compared with chemotherapy alone.

Konvomep, an oral liquid of omeprazole and sodium bicarbonate, will be available in the first quarter of 2023

With this approval, about 300 children between 12 months and 24 months will be eligible for treatment with Orkambi.

HHS is providing $11 million to Grand River Aseptic Manufacturing to accelerate manufacturing of the Jynneos monkeypox vaccine. The facility will be operational later this year.

Spevigo is a monoclonal antibody that inhibits interleukin-36 (IL-36) signaling approved to treat for adults with generalized pustular psoriasis flares.

This application is for a new formulation of carbidopa/levodopa extended-release capsules to treat patients with Parkinson’s disease.

Xenpozyme, the first disease-specific treatment for acid sphingomyelinase deficiency (ASMD), is expected to be available in the United States in the coming weeks at a wholesale acquisition cost of $7,142 per vial.

The approval of the updated bivalent boosters is based on data from clinical studies of the omicron variant BA.1, and animal data on the omicron BA.4 and BA.5 variant.

The Centers for Medicare and Medicaid Services released results today showing that on a per capita basis, the net savings for low-revenue accountable care organizations (ACOs) was higher than the net savings for high-revenue ACOs.

The target action date for the agency’s decision for efanesoctocog alfa, a factor VIII therapy, is Feb. 28, 2023.

Pemazyre is the first approved treatment specifically for patients with FGFR1 rearrangement, a rare blood cancer.

Imbruvica is the first approved treatment option for children under 12 with chronic graft versus host disease and the first BTKi therapy approved for pediatric patients.

Pending authorization, Moderna will be ready to ship the updated bivalent booster in September 2022.

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

Omnipod 5 is now available through retail pharmacies, as well as specialty and mail-order pharmacies.

The updated COVID-19 vaccine booster specifically addresses the omicron BA.4/BA.5 variants. If authorized, it will be available to ship immediately.

Novavax’s vaccine is the first protein-based COVID-19 vaccine authorized in the United States.

Axsome anticipates Auvelity to be commercially available in the fourth quarter of 2022.

Recent approvals include a first generic for the infertility drug Cetrotide, as well as generics of Revatio, Velcade and Esbriet.

Mirena, a long-acting hormonal IUD, was previously approved to prevent pregnancy for up to seven years.

If approved, fezolinetant would treat patients with moderate-to-severe hot flashes and/or night sweats associated with menopause. The PDUFA date is Feb 22, 2023.

Hadlima, a biosimilar of Humira, will be launched next year to treat patients with certain chronic autoimmune diseases.

Bluebird bio has set a wholesale acquisition cost of $2.8 million for the gene therapy beti-cel, now with the brand name Zynteglo, and is offering an outcomes-based contract with an 80% risk sharing.

The FDA has set a Prescription Drug User Fee Act date in the fourth quarter of 2022.

The FDA is expected to make a decision on approval of the combination of Polivy with Rituxan and the R-CHP regimen by April 2, 2023.

If authorized, Novavax’s vaccine would be the first protein-based COVID-19 booster for adults.

The four drugs recently launched include a generic of Clindagel, which received a competitive generic therapy designation from the FDA, for acne and Vasostrict for low blood pressure.

Xofluza is a single-dose, oral therapy and is now approved for children five years and older for both the treatment and prevention of influenza.