Remove 2009 Remove Nurses Remove Pharmaceuticals Remove Regulations
article thumbnail

New Phase 3 Data Show TAK-620 (maribavir), an Investigational Drug for the Treatment of Transplant Recipients with Refractory/Resistant Cytomegalovirus (CMV) Infections, Meets Primary Endpoint

The Pharma Data

About Takeda Pharmaceutical Company Limited. Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Minerva Med.

article thumbnail

PMA Preemption Decision Slides to the Bottom of the “Parallel Claim” Slippery Slope

Drug & Device Law

Thus, “the MDA sets forth a general rule pre-empting state duties having the force and effect of law (whether established by statute, ordinance, regulation, or court decision ). E.g. , Kindred Nursing Centers Ltd. 662, 684-85, 686 (2009) (citations, including to Twombly , omitted). Ortho Pharmaceutical Corp. ,

article thumbnail

A Painful Preemption Decision

Drug & Device Law

555 (2009), a prescription drug preemption case, despite the relevant drug(s) being over-the-counter (“OTC”), and thus approved under an entirely different FDA regulatory process. Bayer Healthcare Pharmaceuticals Inc. The FDA also promulgated an acetaminophen-specific OTC regulation. 14, 2022), leaves us scratching our heads.