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It was a busy week for the FDA. Regulators approved several new therapies, including the first for a rare bone disorder, a combination product for metastatic prostate cancer and a long-acting botulinum toxin for cervical dystonia, as well as an accelerated approved for multiple myeloma. The agency also set review dates for three products, including for full approval of Tarpeyo for a rare kidney disease, an additional indication for Tibsovo for myelodysplastic syndromes and a combination antibiotic for complicated UTIs.

About 20% to 30% of patients with ulcerative colitis will experience acute severe ulcerative colitis in their lifetime.

The patient was in her 70s and began experiencing the floaters the day after undergoing treatment.

Blue Shield is replacing CVS Caremark with Prime Therapeutics as the company that will negotiate with drug manufacturers beginning in January 2025. The insurer is also teaming up with Mark Cuban Cost Plus Drug Company and Amazon Pharmacy.

Cindy Gaines, MSN, RN, chief clinical transformation officer at Lumeon, addresses the current status of electronic health records in the healthcare industry and how automation is filling in its gaps through technology.

In an episode of Managed Healthcare Executive’s “Between the Lines” video series, Leslie Cho, M.D., and Seth Shay Martin, M.D., M.H.S., discussed bempedoic acid, the CLEAR Outcomes trial and the implications for cardiovascular disease prevention.

Joe Pugliese, president and CEO of the patient advocacy group Hemophilia Alliance, discusses recent announcements by manufacturers of two ultra-expensive gene therapies for hemophilia that they will offer payers partial or full reimbursement if patients fail on their therapies.

Scientists say it could lead to new drugs for vitiligo and other pigmentation diseases.

Interoperability has been an aspiration in the healthcare IT world for many years. The finalization of new rules means they finally have a chance to prove its merits.

Ibudilast is a small molecule being developed by biopharmaceutical company MediciNova for the potential treatment of MS. The company, based in La Jolla, California, is currently calling the oral formulation MN-166.

As the Federal Trade Commission weighs a ban, hospitals and some physician organizations are on opposite sides of the issue.

The track record on outsourcing clinical services is mixed.

This clinical trial is a part of the NIH's Researching COVID to Enhance Recovery (RECOVER) Initiative, aimed at understanding, treating and ultimately preventing the symptoms experienced by individuals following SARS-CoV-2 infection.

The FDA has approved Talvey, a new therapy for treating multiple myeloma patients. The agency has also issued a complete response letter for avasopasem for severe oral mucositis and set a PDUFA date for a monthly MS drug.

However, patients who cannot get insurance coverage will be able to access AspyreRx at a significant self-pay discount.

A discussion with Jeffrey Casberg, M.S., who joined the Managed Healthcare Executive editorial advisory board in July 2023. Casberg is senior vice president of clinical pharmacy at IPD Analytics and has played a leadership role in its drug management strategy business. A pharmacist by training, Casberg has had a long career in managed care.

Briana Contreras, an editor of Managed Healthcare Executive, had the pleasure of catching up with MHE Editorial Advisory Board Member, Ateev Mehrotra, MD, MPH, who is a professor of healthcare policy at Harvard Medical School and an Associate Professor of Medicine and Hospitalist at Beth Israel Deaconess Medical Center.

A post hoc analysis of two phase 3 trials identified that as many as 95% of patients with chronic rhinosinusitis with nasal polyps (CRSwNP) had type 2 inflammatory signatures depending on the definition of inflammation used.

Charging more than $2 million for a single treatment was once unthinkable, but no more.

Recent years have brought a host of new orphan medications for rare disorders, and more are coming. But the U.S. hasn’t yet settled on a way to handle their often astronomical prices — and neither has any other country.

More than half of participants completed the eight-week course, the authors said.

FDA Approves new indications for two cancer drugs: Lonsurf combination for metastatic colorectal cancer and Jemperli as frontline treatment for advanced endometrial cancer. The agency has also rejected the BLA for therapy to treat rare skin cancer.

To support a value-based care model, healthcare organizations should focus on creating meaningful engagement throughout the patient's journey. This includes contacting patients at the right time through the right channel with relevant messages.

A recent report shared the market's expansion is mainly driven by the growing prevalence of chronic diseases, which has increased the demand for remote health monitoring and efficient healthcare solutions.

The answer is no. Research findings reported in JAMA Network Open show no association between hepatitis B status and poor birth outcomes among those who get pregnant with freeze-thaw embryo transfer whereas among natural births, hepatitis B infection in mothers is linked to miscarriage and preterm birth.

Two studies show that high heart failure rates in the Black population are a legacy of discriminatory mortgage policies.