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Axinn, Veltrop & Harkrider LLP

Pounding the Compounders: FDA’s “No Compound” Lists

Axinn, Veltrop & Harkrider LLP on

Novo Nordisk recently made headlines petitioning FDA to stop the compounding of its blockbuster GLP-1 products so it can sell its patented semaglutide drugs exclusively. Compounding is the practice of creating new drug...more

WilmerHale

PTAB/USPTO Update - November 2022

WilmerHale on

USPTO News - ..On October 19, 2022 the USPTO issued a report titled “Where are U.S. women patentees? Assessing three decades of growth” examining trends in women’s patenting in the U.S. from 1990-2019. ..Director...more

Katten Muchin Rosenman LLP

FDA Reduces Regulatory Uncertainty with New Finalized Rule Defining "Biological Product" under BPCIA to Include Insulin and Other...

Katten Muchin Rosenman LLP on

Key Points - In February, the U.S. Food and Drug Administration issued a "bright-line rule" redefining "biological products" under the Biologics Price Competition and Innovation Act (BPCIA) to include insulin and other...more

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