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No Sleep ‘Til District Court: Jazz Sues FDA Over Sodium Oxybate Clinical Superiority Determination

FDA Law Blog

This time, rather than use codes and patent certifications, the fight is over orphan drug exclusivity (“ODE”), with Jazz challenging FDA’s clinical superiority decision concerning sodium oxybate in the treatment of narcolepsy. 360cc(c), the statute does not permit FDA to promulgate regulations to use clinical superiority to break ODE.

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Rewiring the body clock: Deep brain imaging reveals unexpected complexity in jet lag adjustment

Medical Xpress

This region governs essential behaviors like the circadian clock, sleep, energy balance , and feeding. Po-Ting Yeh, the studys first author, explains the challenge: "It is difficult to study the basic physiological functions controlled by the hypothalamus, which lies deep inside the brain.

Provider 109
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The importance of social connection: Julianne Holt-Lunstad, Thomas Cudjoe, & Carla Perissinotto

GeriPal

Are there meaningful ways of assessing loneliness and social isolation in clinical settings and connecting patients with interventions? The Listening “EAR” approach that simplifies assessment of loneliness and social isolation in clinical settings, and other practical pointers.

IT 99
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Gabapentinoids – Gabapentin and Pregabalin: Tasce Bongiovanni, Donovan Maust and Nisha Iyer

GeriPal

2011-2014 JAMDA 2020 Efficacy of Gabapentinoids: Gabapentinoids for Pain: Potential Unintended Consequences. I understand that it can be a hard place clinically. We should be able to trust all the data that comes from our governing board. AFP 2019 Gabapentin for chronic neuropathic pain in adults. But we should highlight that.

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Writing for the Lay Public: Rosanne Leipzig and Louise Aronson

GeriPal

And then I feel like when I’m in clinic I’m helping individuals, and you only have so much time to help so many people. In clinic, I’m helping what, hundreds or thousands. When I write, I learn a ton from that. And I tend to think of writing as my version of public health. Even if I write a scholarly article.

IT 105
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Long-lasting HIV prevention shot headed toward approval

Medical Xpress

The company is working with governments and health groups in the U.K. In clinical trials, no participants who received the injection acquired HIV. But Gilead says the shot should help expand the overall number of people using PrEP in both the U.S. and abroad. © 2025 HealthDay.

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Trump Says He’ll Stop Health Care Fraudsters. Last Time, He Let Them Walk.

Physicians News Digest

By Brett Kelman Five years ago, the CEO of one of the largest pain clinic companies in the Southeast was sentenced to more than three years in prison after being convicted in a $4 million illegal kickback scheme. But after just four months behind bars, John Estin Davis walked free.