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Generic Drugs Food and Drug Administration (FDA) Novartis

Robins Kaplan LLP

Piramal Healthcare US Ltd. v. Novartis Pharms. Corp.

Robins Kaplan LLP on

Case Name: Piramal Healthcare US Ltd. v. Novartis Pharms. Corp., No. 19-12651 (SRC), 2020 U.S. Dist. LEXIS 38849 (D.N.J. Mar. 5, 2020) (Chesler, J.)....more

Patrick Malone & Associates P.C. | DC Injury...

For patients’ sake, U.S. must slap down Big Pharma chiseling on tests, trials

Big Pharma is testing crucial boundaries in the way that the nation determines the safety and effectiveness of prescription medications. And regulators, for patients’ sake, need to shove back — hard....more

Robins Kaplan LLP

Novartis Pharms. Corp. v. Breckenridge Pharm., Inc.

Robins Kaplan LLP on

Case Name: Novartis Pharms. Corp. v. Breckenridge Pharm., Inc., Civ. Nos. 14-1043-RGA, 14-1196-RGA, 14-1289-RGA, 2017 U.S. Dist. LEXIS 46595 (D. Del. Mar. 28, 2017) (Andrews, J.)....more

BakerHostetler

A Step Forward in Approving Lower-Cost “Generic” Biologic Drugs

BakerHostetler on

A federal advisory panel has helped clear the path for what may be the first biosimilar biologic drug ever approved in the United States. Interestingly, generics of traditional drugs have been available in the U.S. for...more

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