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Pharmaceutical Industry Genetic Markers

Sheppard Mullin Richter & Hampton LLP

Day 2 Notes at the 2020 J.P. Morgan Healthcare Conference

The Big Cost; Cancer is the Answer; and SDOH Evolves - The Big Cost: You’re okay today, and then tomorrow you’re not. Life has changed and there’s a new reality. Whether it’s an acute event – an accident, a heart attack, a...more

Foley & Lardner LLP

The Era of Personalized Medicine Has Arrived - PMC’s Annual Progress and Outlook Report

Foley & Lardner LLP on

The Personalized Medicine Coalition (PMC) released its annual “Personalized Medicine At FDA: A Progress & Outlook Report” (Report) that monitors current successes and challenges in bringing personalized therapies to market....more

Hogan Lovells

FDA Cleared First DTC Genetic Tests for Health Risks

Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) granted marketing authorization for 23andMe’s Personal Genome Service (PGS) Test for 10 diseases or conditions. This was the first FDA authorization for a...more

Foley & Lardner LLP

EMA’s New Draft Guideline On Good Pharmacogenomic Practice - Implications For Personalized Medicine

Foley & Lardner LLP on

Embracing personalized medicine, the European Medicines Agency (EMA) released a draft guidance document titled Draft Guideline on Good Pharmacogenomic Practice (“Guidance”) on good pharmacogenomic practice with the stated...more

BakerHostetler

The Proposed Common Rule: The Tribe Has Spoken, and They Have Concerns

BakerHostetler on

On September 8, 2015, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a notice of proposed rulemaking (NPRM) to update the federal policy for the Protection of Human Subjects, more...more

Foley & Lardner LLP

Personalized Medicine: An Industry Report

Foley & Lardner LLP on

Increasingly, the development of new pharmaceuticals utilize genetic information to stratify patient subpopulations and/or predict efficacy and adverse events – the development paradigm of personalized medicine....more

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