FDA Law Blog

FEBRUARY 21, 2022

Dr. Unger is a cardiologist and former Director of the Office of Drug Evaluation-I in FDA’s Office of New Drugs in the Center for Drug Evaluation and Research (“CDER”). He completed his cardiology training at The Johns Hopkins Hospital in 1987. Unger led a translational research program on promotion of angiogenesis.

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The Pharma Data

JANUARY 12, 2021

12, 2021 (American Heart Association News) — Researchers are soon expected to release initial findings from a national cardiac registry of NCAA athletes who have tested positive for COVID-19 , giving hope to health care professionals trying to better understand the impact of the disease on the heart. TUESDAY, Jan.

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pharmaphorum

NOVEMBER 16, 2020

People always say that patients and doctors should share decision making and discuss treatments with one another, but in reality, most of us just follow the guidelines. The only problem at the moment is that it’s not what doctors are taught to do. The mean benefit there would be 1.7 Applying a new model.

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The Pharma Data

DECEMBER 16, 2020

The absolute numbers are small, and individual women should not be alarmed, said senior researcher Dr. Samir Kapadia, chairman of cardiovascular medicine at the Cleveland Clinic in Ohio. But while the reasons for the disparity are not nailed down, doctors need to be aware of it, Kapadia said. of Black women, compared to 0.1%

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The Pharma Data

NOVEMBER 4, 2020

If your doctor decided that urgent treatment with ULTOMIRIS is needed, you should receive meningococcal vaccination as soon as possible. Your doctor will decide if you need additional vaccination. Your doctor will give you a Patient Safety Card about the risk of meningococcal infection.

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The Pharma Data

JANUARY 21, 2021

21, 2021 – – With rising obesity rates, more young women American women are developing type 2 diabetes , putting them at hugely increased risk for heart disease, new research shows. ” One other expert said such research is long overdue. 20 in the journal JAMA Cardiology. THURSDAY, Jan.

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The Pharma Data

JANUARY 5, 2021

5, 2021 — Kids born with heart defects may be more likely to develop anxiety , depression and/or attention-deficit/hyperactivity disorder (ADHD), regardless of the severity of their heart condition. These children often miss school and social activities due to doctors’ visits or health restrictions. . TUESDAY, Jan.

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The Pharma Data

JANUARY 27, 2021

Adding a chapter on pregnancy complications puts that issue “front and center,” said Dr. Salim Virani, chair of the report’s writing committee and a professor of cardiology and cardiovascular research at Baylor College of Medicine in Houston. And the problems don’t end once the pregnancy does.

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The Pharma Data

JULY 8, 2021

vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. vice president, Product Development, Lilly. vice president, Product Development, Lilly. ” The EMPEROR-Preserved trial investigated Jardiance 10 mg compared with placebo. .”

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The Pharma Data

NOVEMBER 4, 2020

However, while telemedicine seemed to make it easy to check in with a primary care doctor, a new study suggests that wasn’t the case for everyone. To come to that conclusion, the researchers used 2016-2017 data on more than 910,000 participants in a national questionnaire from the U.S. .” WEDNESDAY, Nov.

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The Pharma Data

NOVEMBER 16, 2020

When taken on its own, the polypill reduced by about 20% the risk of heart attack, stroke, procedures to reopen clogged arteries and other heart disease, the researchers reported. It would be easier for patients, who wouldn’t have to juggle fistfuls of daily medications, and for doctors who’d only have to write one prescription.

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The Pharma Data

NOVEMBER 4, 2020

Expanded m edical society recommendations in support of the efficacy and safety of VASCEPA : The European Society of Cardiology expanded their guidelines to recommend use of VASCEPA in treating acute coronary syndrome patients. Research and development (R&D) expense for the three and nine months ended September 30, 2020 were $10.2

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The Pharma Data

JANUARY 26, 2021

Mr. Serota is a founding member of the National Business Group on Health’s Institute on Healthcare Costs and Solutions, a Board member of Brain Research Foundation, and an advisory board member of Paragon Biosciences. Notably, Mr. Serota was appointed by President George W. About Itamar Medical Ltd.

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