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The therapy had received accelerated approval in 2011 but a phase 3 confirmatory trial found it did not meet the end point of progression-free survival.

The sickle cell disease therapy will now be on the Preferred Drug List.

Amida Care’s Doug Wirth says they should work with state-level officials to make sure services are covered after Biden administration’s guidance that coverage is mandatory.

Newly approved drugs put the brakes on particular “driver mutations,” that when unimpeded, rev up the runaway cell growth and division that characterizes cancer.

This is the first new approval for lupus in a decade.

The agent targets excessive daytime sleepiness.

Patients with high amplification of the MET gene had a response rate of 38.1%, more than twice the response rate of those with medium amplification.

Pharmacies will need to obtain pre-dispense authorization for clozapine.

The favorable results could mean a new treatment option for patients with HIV whose disease has not responded to other treatments. They may also be another step toward HIV treatment that doesn’t depend on daily pills.

Approval of the first interchangeable biosimilar; new indications for Keytruda, Botox, and Nucala; Shingrix label's expanded to a new patient population; and Ardelyx’s Complete Response Letter round out this week's FDA news.

Some fatal cases of ketoacidosis have occurred, and high-risk patients should be monitored when starting treatment.

Study finds antibiotics, antidepressants, anti-platelets and other drugs contribute to adverse events and mortality.

In this special episode of Tuning In to the C-Suite podcast, MHE Associate Editor Briana Contreras met with HM Insurance Group Sales Director Adam Gottesman to discuss the ongoing and critical need for reinsurance in healthcare.

Gurpreet “Sunny” Singh, chairman of the board at Edifecs, said he follows a philosophy in life that stretches from his time at Montana State University in the 1980s, directly to his work today, at Edifecs, and in India to improve the lives of billions through innovative wellbeing initiatives with RoundGlass. “My father always encouraged me to pursue my passions and to dream big. He also raised me to be generous and compassionate – to honor the human spirit. This is something that I’ve carried with me for my entire life, and it’s shaped the work that I do.”

Hospitals can't go back to their old ways. They need high-tech, high-touch strategies to engage patients.

The FDA is requesting an additional study to demonstrate tenapanor lowers serum phosphorus.

FDA approval means that pharmacists can swap biosimilar Semglee, an insulin product, for brand-name Lantus, although state-level pharmacy rules may apply.

Wide ranging report covers a lot of ground. It sounds an optimistic note about biosimilars but is critical of white bagging.

In this week’s episode of Tuning In to the C-Suite podcast, MHE had the pleasure of speaking with Sach Jain, CEO of Carrum Health. In the discussion Jain touched on how adopting value-based care is treating conditions and lowering cost burdens, but there remains to be concern in medical spend when it comes to planned surgeries. Jain also talked about how adopting bundled payments can be just as good of a solution as the newer price transparency rule when assisting in patient’s high medical costs.

The findings were similar in people with or without diabetes.

The United States does not have a uniform health system and has no universal healthcare coverage. The health disadvantage of the U.S. relative to other high-income countries is health disparities in health services.

Michael Zeglinski, senior vice president and CEO of specialty and infusion pharmacy at OptumRx, has applied the experiences he had playing the French horn in orchestras to his increasingly important roles in healthcare: “Being in an orchestra has its own dynamics — the conductor, being part of a team and doing your best to contribute to the whole. All of that applies to business.”

Key factors for determining shift length will help manage fatigue-related risks while meeting operational demands.

Study shows that nonsmall cell lung cancer patients who smoke but quit after their diagnosis have better overall survival, progression-free survival than patients who continue to smoke.

A substantial discount would be needed to meet cost-effectiveness thresholds.

As COVID-19 precautions are dwindling throughout the world, this upcoming flu season could re-heighten those precautions.

The FDA would like to see additional data on clinical benefit for patients with anal cancer.

Angiotensin receptor blockers may be less likely to cause side effects than ACE inhibitors.