Denise Myshko

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.

Investigators found only small differences in the change in LDL-C levels in the incentive groups versus the control group

The labeling of Trikafta, which treats cystic fibrosis, has been updated to warn about the possibility of liver failure that could lead to the need for transplantation.

Talicia treats H. pylori infection, a risk factor for stomach cancer; Twirla is a hormonal contraceptive.

Three products, including Pfizer’s smoking cessation product Chantix, have been removed because generics are now available.

The labeling for selective serotonin reuptake inhibitors (SSRIs) and selective serotonin-norepinephrine reuptake Inhibitors (SSNRIs) now must include information about sexual side effects in the warning and precautions and patient counseling sections.

Aetna, Cigna and UnitedHealthcare are enhancing their Medicare pharmacy benefits, including offering insulin for a copay of no more than $35 for a 30-day supply.

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.

Given together, bamlanivimab and etesevimab have an emergency use authorization from the FDA to both treat COVID-19 and prevent infection in those who have been exposed.

Effective Oct. 1, 2021, Aetna has added several cancer drugs to its formulary and has updated exclusions and nonpreferred products.

Comprehensive medication management aided by AI clinical decision support can result in a large return on investment in a high-risk population. In this study, every dollar that was invested resulted in $12 in savings or cost avoidance.

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 companies are seeking accelerated approval based on the surrogate end point of beta amyloid reduction.

The flu program is the first in programs leveraging BioNTech’s mRNA technology for vaccines for other respiratory viruses, oncology, and genetic diseases.

Effective Jan. 1 2022, the move brings the price to 2008 levels.

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.

Shifting cancer patients to the physician setting for administration of cancer therapies could save insurers $1.28 billion.

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.

People over the age 65 and those at high risk of severe COVID-19, including health care workers and those with occupational exposure, are eligible for the booster.

Biogen/Samsung Bioepis’ Byooviz is a biosimilar of Genentech’s Lucentis.

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

The vaccines advisory committee voted late on Friday, September 17, 2021, to provide emergency authorization of Pfizer’s COVID-19 vaccine as a booster for those over the age of 65, as well as for those at high risk of developing severe disease.

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.

To date, Pfizer has not received reports of adverse events related to this recall, but is making the move as a precaution.

The combination of bamlanivimab/etesevimab can now be given to both treat and prevent COVID-19 infection after exposure.

Regeneron also announced an expanded contract with the U.S. government for the purchase of additional doses of REGEN-COV.