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Former FDAer Dr. Ellis F. Unger Joins Hyman, Phelps & McNamara, P.C. as Principal Drug Regulatory Expert

FDA Law Blog

Unger has joined the firm as a Principal Drug Regulatory Expert. 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.

Drugs 40
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Velocity Clinical Research Expands to Poland

Velocity Clinical Research

In addition to being one of Poland’s top recruiting sites in cardiology trials, ClinMedica also recruits patients across a broad range of therapeutic areas involving ambulatory medicine. About Grzegorz Kania, MD Grzegorz Kania, MD specializes in cardiology as well as internal and family medicine. and Europe. and Europe.

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Towards a new understanding of cardiovascular risk in diabetes

pharmaphorum

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.

Doctors 76
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Velocity Expands to 17 Sites in Europe

Velocity Clinical Research

In my new role as Vice President Corporate Development (CEE) and Medical Director (CEE) together with my expertise of building out a site network, I intend to support the development of Velocity in Poland and in Europe more widely.” About Marek Konieczny, MD, PhD Dr. Konieczny is a specialist in cardiology and internal medicine.

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Alexion Announces Upcoming Data Presentations at the 62nd American Society of Hematology Annual Meeting and Exposition

The Pharma Data

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.

Doctors 52
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Breakthrough results for Jardiance® (empagliflozin) confirm EMPEROR-Preserved as first and only successful trial for heart failure with preserved ejection fraction

The Pharma Data

vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. vice president, Product Development, Lilly. vice president, Product Development, Lilly. Food and Drug Administration (FDA), with a decision expected later this year.

Trials 52
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Amarin Reports Third Quarter 2020 Financial Results and Provides Business Update

The Pharma Data

District Court ruling in favor of two generic companies in connection with their abbreviated new drug applications, or ANDAs, related to VASCEPA capsules in its initial triglyceride lowering indication. Research and development (R&D) expense for the three and nine months ended September 30, 2020 were $10.2 million and $30.5

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