News

In COVID-19 news, the FDA indicated Eiger’s treatment not supported by data. An advisory committee switched its vote to yes for new ALS drug. The FDA approved Stimufend, a biosimilar to Neulasta, as well as Imfinzi for biliary tract cancer, a longer-lasting treatment for frown lines, an oral suspension for gastric ulcers, and generics of Revlimid. The agency accepted applications for novel dry eye disease and alopecia therapies. Additionally, Seres completed rolling BLA for microbiome therapeutic.

In a second committee meeting, FDA advisors supported approval of AMX0035 after the company presented additional analysis of phase 2 data of AMX0035 to treat patients with ALS. The Prescription Drug User Fee Act (PDUFA) target action date is Sept. 29, 2022.

Risk adjustment is a central feature of value-based care, but it can be abused. Natural language processing can make the process efficient and steer it clear of fraud and other problems.

A national study in Germany identified the baseline characteristics of patients with moderate-to-severe atopic dermatitis (AD) to understand how they are usually treated with Dupixent in the real world.

In COVID-19 news, the FDA authorized updated boosters. The agency also approved several new therapies, including Xenpozyme for a rare genetic disorder, and Pemazyre for myeloid/lymphoid neoplasms, Spevigo for rare type of psoriasis flare. The FDA also expanded Imbruvica’s indication for young children with GVHD and granted priority review for weekly hemophilia A therapy.

Therapeutic goals of reducing eosinophil counts below a certain level in eosinophilic esophagitis (EoE) has a marginal benefit for the impact on quality of life and treatment burden.

In this week's episode, MHE Editor Briana Contreras and Managing Editor Peter Wehrwein met with CIO of Prime Therapeutics, Jim Graham to discuss the process of an organization’s digital transformation from a traditional Pharmacy Benefit Manager to a complete data-driven drug management system. Graham addressed the risks an organization may come across to successfully transition to this system, but also mentioned the benefits to come.

CIO of Prime Therapeutics, Jim Graham, discusses with MHE how to successfully reach digital transformation in healthcare from a traditional PBM.

Telemedicine has skyrocketed during the COVID-19 pandemic, but what actions are needed for more patients to have equitable, fair access to genetics services via telegenetics?

Kaiser Family Foundation research shows that an 8% increase in enrollment from 2021 to 2022.

In COVID-19 news, both Pfizer and Moderna have submitted applications for an updated booster vaccine, and the FDA grants EUA for Novavax vaccine for adolescents. The agency also approved rapid-acting Auvelity for major depression, expanded Imbruvica for young children with GVHD, expanded use of Omnipod 5 for younger children, and accepted an NDA for GSK’s myelofibrosis drug.

The nearly $19 million boost comes after the Inflation Reduction Act extended enhanced premium tax credits for ACA marketplaces policies through 2025.

Twenty percent of nurse managers are considering leaving the profession, and amid unprecedented burnout and turnover among nurses at all levels, there’s increased urgency for healthcare organizations to develop a formal nurse manager succession plan

Back from a brief hiatus, MHE brings you a brand new episode of Tuning In to the C-Suite podcast where Editor Briana Contreras had the pleasure of speaking with Lissy Hu, president of Connected Care Networks at WellSky. Lissy and Briana discussed the shift to home-based care and where it stands after becoming much more of a norm three years into COVID-19. They also addressed the benefits and challenges of home-based care from a payer and patient’s perspective, as well as the cost of this service as its demand rises.

Sarah Raaii, co-chair of McDermott Will & Emery’s multidisciplinary post-Roe team, and Cat Duffy, policy analyst of the National Health Law Program, address the Dobbs v. Jackson Women's Health Organization decision of the U.S. Supreme Court in which the court held that the Constitution of the United States does not confer a right to abortion.

Women traveling out of state for a medication abortion may wind up using telehealth.

CVS Health and United Health Group are also reportedly among the bidders.

There are many misconceptions about healthcare technology, but you can improve your organization’s approach to IT by clearing them up and following these three steps.

In COVID-19 news, Novaxax seeks EUA for vaccine booster. The FDA has approved Bluebird’s $2.8 million gene therapy for blood disease, as well a high-concentration of Hadlima, a Humira biosimilar. The agency has also PDUFA for several products, including Lynparza/abiraterone prostate cancer, Polivy for a blood cancer, and fezolinetant for menopause.

After a failed trial in advanced breast cancer, Sanofi has stopped all studies of amcenestrant, including in early-stage breast cancer.

Shabbir J. Imber Safdar, executive director, Partnership for Safe Medicines, talks about efforts to address counterfeit drugs in the U.S. supply chain.

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

Opinion piece on the top 5 priorities for managed care by Managed Healthcare Executive Editorial Advisory Board Member, Don Hall, M.P.H.,principal of DeltaSigma, LLC.

Interviews with people with myeloproliferative neoplasms show almost all of them often feel fatigued — and that they must manage the problem on their own.

The new report is believed to be among the first to examine cardiovascular risk in myeloproliferative neoplasms through a genetic lens. Mutations in the CALR gene may restore vascular dysfunction in some patients.

The new model starts in July 2023. Practices will be required to take on two-sided risk right from the start.

In a busy week, the FDA has approved additional indications for Enhertu, Myfembree and Nubeqa, as well as a tablet form of Calquence. The agency also approved Xofluza for children, issued an EUA for monkeypox vaccine in children, extended the review of omaveloxolone, set up advisory committee meeting for microbiota-based C. diff therapy, and priority review for elacestrant in breast cancer. Additionally, Novaliq submited NDA for dry eye treatment.

Investigation into additional agents to treat patients with COVID-19 through the I-SPY COVID Trial is ongoing.