Denise Myshko

Safety concerns may limit JAK inhibitors as treatment for the common skin condition.

Drugs that the FDA has approved on its fast-track accelerated approval basis are making up an increasingly larger share of Medicaid spending on pharmaceuticals.

An understanding of hemoglobin levels in patients with COPD could help guide disease management.

In COVID-19 news, FDA issues EUA for Pfizer vaccine for children. The FDA approved a therapy for macular edema and a novel pain treatment. And Novartis submits application for new indication for Kymriah.

Recently approved for children 6 to 11 years, Dupixent reduces severe asthma attacks and improves lung function.

In COVID-19 news, the FDA issues EUA for both Moderna’s and J&J’s COVID-19 booster. In new drug approvals, there is a novel therapy for macular degeneration, new therapies for eye disease and opioid overdose, as well as new therapies for asthma and HIV in children.

The tools for formulary management for atopic dermatitis need flexibility to take into account quality-of-life issues and patient access.

In COVID-19 news: An advisory committee recommends both J&J's and Moderna’s booster, Regeneron seeks full approved for its treatment and Merck seeks EUA for treatment. In cancer, the FDA approves Verzenio for early breast cancer, Keytruda for advanced cervical cancer, and Tecentriq in early nonsmall cell lung cancer.

This European study enrolled patients with more severe cases of spinal muscular atrophy than a similar study conducted in the U.S.

A new method for delivering this treatment drug for spinal muscular atrophy offers an option for patients with advanced cases of the disease. But investigators found that the new method may also carry risks of mechanical failure and infection.

Pfizer officially seeks EUA for pediatric COVID vaccine, AstraZeneca seeks EU for COVID-19 prevention, J&J submits data for COVID-19 booster, a gene therapy is approved for leukemia, and Janssen submits Stelara for psoriatic arthritis in children.

Rinvoq, a JAK inhibitor, is still under review at the FDA as a treatment of atopic dermatitis.

Incyte will be required to conduct postmarketing study and set up patient registry to monitor whether the topical JAK inhibitor has adverse effects on mothers, fetuses and infants.

The FDA is scheduled make a decision on injectable cabotegravir by Jan. 24, 2022.

Approvals include a therapy for a rare disease for children and a novel migraine prevention. New regulatory applications include Biogen’s second Alzheimer’s therapy and other indications for Opdivo and Erbitux, and Pfizer submits data for COVID-19 vaccine for children.

Small biotech companies such as Scholar Rock and Cytokinetics have treatments in late-stage trials for spinal muscular atrophy. Novartis and Biogen also have products in the pipeline.

The FDA has approved three targeted therapies for spinal muscular atrophy. They have hefty price tags so cost and affordability are live topics.

Pfizer receives an EUA for its COVID-19 booster, a biosimilar of Lucentis to treat macular degeneration is approved, Incyte receives two approvals for JAK inhibitors, one for atopic dermatitis and another for GVHD, and more FDA news.

A company developing a new therapy for hypertrophic cardiomyopathy released data recently showing that people with the obstructive form of the disease often develop hypertension, atrial fibrillation and other forms of cardiovascular disease.

Black HCM patients were more likely than White HCM patients to have mid-ventricular obstruction, according to recently reported findings.

Advisory panel endorses Pfizer vaccine booster for some, Brukinsa gets third indication, oral migraine med makes headway and other FDA-related news this week.

Tezepelumab, which is being currently reviewed by the FDA, provides small improvements in daily symptoms and quality of life but is only modestly cost-effectiveness at the anticipated price, according to the cost-effectiveness group's calculations.

Clinical appropriateness, not the cost of a drug, is the first consideration in formulary decisions, said Katie Thompson and Katie Deckelbaum of Express Scripts.

Confidio VP Thatcher Sloan described how applying formulary and utilization management effectiveness calculations to drug costs managed by PBMs may paint a truer picture of their economic value to their clients.

WellDyne executives David Skomo, RPh, and Nick Page told PBMI Annual Conference attendees that matching communication channels and messages with patient preference is the way to engage patients and increase adherence.

Amazon is gearing up for an era that includes telehealth and home testing, but the former FDA commissioner says the new model is more than a logistics challenge and that healthcare companies will prevail.

Patients faced with high out-of-pocket costs sometimes delay seeking care for appendicitis or diverticulitis, which can result in higher overall costs, increased risk of mortality, and a worse quality of life.

Approvals for a twice-yearly schizophrenia therapy and a seizure drug for infants, a full approval for Keytruda, and a revised EUA for a COVID-19 therapy round out the week.

Mobile devices for patients to report symptoms associated with immune checkpoint inhibitors address an unmet need.

Greater uptake of hepatitis C medication may help improve the health of Medicaid enrollees and reduce the economic burden of untreated hepatitis C on the U.S. healthcare system, the authors said.