FDA Law Blog: Biosimilars

JULY 21, 2024

The plaintiffs in that case— Alliance of Nurses for Healthy Environments, et al v. Alliance for Nurses started as a Citizen’s Petition back in 2016, making its way to District Court when FDA took no action. The unanimous Court held that the doctor-plaintiffs in Hippocratic Medicine had not suffered direct, causal injury.

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Nurses FDA Testimonials Doctors 59

The Pharma Data

NOVEMBER 7, 2020

8, 2020 /PRNewswire/ — Since doctors began treating cancer patients with immunotherapy drugs called checkpoint inhibitors nearly a decade ago, they have observed that a subset of these patients experience a side effect that clinically looks like inflammatory arthritis. NEW YORK , Nov.

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Nurses Hospitals RNA Doctors 52

The Pharma Data

NOVEMBER 13, 2020

12, 2020 (American Heart Association News) — In the late 1990s, when she was in her 40s, Dona Koster’s doctor noticed some irregularities with her heart and referred her to a cardiologist. At daybreak, her husband, Tom, drove her to the hospital, where a doctor removed 12 pounds of fluid from around her heart.

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Doctors Nurses Hospitals Disease 52

Codon

JANUARY 21, 2024

licensure of a cholera vaccine in 2016, established correlates of protection for influenza that same year, and helped accelerate approval of paratyphoid vaccines in 2019. A few people died in those early challenge trials, though, including a nurse named Clara Maass , who was challenged multiple times.

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Vaccine Trials Disease Virus 111

The Pharma Data

MAY 13, 2021

Description: How A Handsome Doctor From Texas Saved My Life. I could hear doctors and nurses speaking in hushed tones…. I gave up carbs, fats, alcohol, meat – just as the doctor ordered…. And Mary-Anne, a nurse from Arkansas, who says…. My doctor said it was all simple math…. And the energy, my god.

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Drug & Device Law

DECEMBER 29, 2023

While these five FDA findings (the last in response to the MDL court’s invitation for the FDA to participate directly in this litigation) were nails in these experts’ Rule 702 coffins, they would also support reversing this MDL’s prior adverse preemption decision ( 2016-10 ). The G/N MDL was created in 2013 and mostly settled in 2016.

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