News

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.

Exactly how Byooviz will be priced is unclear, noted George W. Williams, M.D., a retina specialist and past president of the American Academy of Ophthalmology. The exact cost savings will help determine whether the biosimilar gains acceptance.

Blue Plans will now have an additional home delivery option that they can choose to offer their members.

Many states only have vaguely worded qualitative standards for network adequacy for cancer care. Others have quantitative standards based on distance or waiting time.

1 in 10 patients with early-onset atrial fibrillation have gene variants associated with a cardiac disease, most commonly some form of cardiomyopathy, according to research conducted by Vanderbilt researchers. Results would justify routinizing genetic testing of young afib patients, the researchers said.

A rare mutation of the ALPK3 gene has been shown to result in more serious cases of hypertrophic cardiomyopathy.

The FDA rejected Humanigen’s application for an emergency use authorization, but the race is on to develop an effective therapy for the cytokine storms that affect patients with COVID-19.

Merck plans to seek emergency use authorization for molnupiravir as the first oral treatment for COVID-19.

The Annual report shares actual cost trends and expectations for the future of healthcare.

Health officials should consider advise that people spend more time outdoors as. way to cope with this and future pandemics, the researchers suggest.

Data show that the vaccine was 94% effective against moderate infection and 100% effective against severe disease.

Medicare negotiation of drug prices would stifle the development of much-needed therapies. Curtailing defensive medicine and rolling back excessive regulation would be a better way to control healthcare costs.

A review of more than 200 studies found no greater risk of contracting COVID-19 among those with HIV but a greater chance of experiencing a severe case.

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.

Cigna has expanded its Medicare Advantage plans for the third consecutive year in as Medicare Advantage premiums lower per month in 2022.

Liquid biopsies and new MRI technology may help clinicians monitor and stratify patients by the likelihood of whether their liver disease will worsen.

Trudhesa was approved in September to treat migraine.

This week, MHE editors Briana Contreras and Peter Wehrwein chat with MHE Editorial Advisory Board Member Cindy Hundorfean for the latest episode of the Meet the Board podcast series. Hundorfean, who is CEO of Allegheny Health Network, told MHE a few things about her time with the Cleveland Clinic, where Allegheny Health Network stands in the competitive Pittsburgh healthcare market and what the organization is doing to improve the health of the population.

Many healthcare organizations are learning that creating an effective, scalable remote monitoring program is not easy. Most engage only about half of eligible patients. When patients do engage, providers struggle to keep them connected, find actionable insights in the data, and achieve optimal reimbursement.

The company has also launched a website for patients affected by hereditary angioedema, a rare genetic disorder.

Results from a survey conducted by DirectPath revealed many consumers still lack the knowledge required to make informed choices about their health plan and care, which displays as a concern for healthcare education and transparency.

The enzyme replacement therapy treats Pompe disease, a rare genetic disorder that affects children.

In this excerpt of an interview with Managed Healthcare Executive®, Paulus discusses the COVID-19 pandemic, Prime's response and the future of its headquarters building.

Data is being presented at the 10th Annual IDWeek Virtual Conference, September 29 to October 3.