By Kurt R. Karst – A little over three months ago, we on a Complaint and a Motion for Temporary Restraining Order and Preliminary Injunction Takeda Pharmaceuticals U.S.A., Inc.’s (“Takeda”) filed against FDA in the U.S. District Court for the District of Columbia challenging the …
By James C. Shehan – FDA’s Oncologic Drugs Advisory Committee unanimously voted in favor of approval of EP2006, Novartis’s biosimilar version of Amgen’s Neupogen® (filgrastim) for all five of the indications for which Neupogen is approved. This ground-breaking event manages to both move the US a …
By Kurt R. Karst – Late last month, the Pharmaceutical Research and Manufacturers of America (“PhRMA”), the Biotechnology Industry Organization (“BIO”), and the Generic Pharmaceutical Association (“GPhA”) jointly filed a Petition for a Writ of Certiorari (Case No. 14-751) with the U.S. Supreme Court asking the …
By Kurt R. Karst – It’s been many months since we last posted on the issue of so-called “premature notice” (and over a year since we first posted on the issue). Premature notice is notice – ineffective notice – of a Paragraph IV certification sent to …
By Kurt R. Karst – In what is, to our knowledge, a first-of-its-kind written decision, Judge Esther Salas of the U.S. District Court for the District of New Jersey issued an Oral Opinion and Order on December 22, 2014 granting without prejudice in part and denying …
By Kurt R. Karst – Last week, the Federal Trade Commission (“FTC”) announced the issuance of the Bureau of Competition’s annual summary of agreements filed with the Commission during the last fiscal year (Fiscal Year 2013) – Agreements Filed with the Federal Trade Commission under the …
By Anne Marie Murphy – On December 24th, in response to industry requests, FDA issued a guidance document indicating that it will not enforce product tracing requirements of the Drug Supply Chain Security Act ("DSCSA") prior to May 2015. The guidance, states in relevant part: FDA recognizes that …
By Kurt R. Karst & Michelle L. Butler – Ever since FDA withdrew a notice of appeal in Depomed Inc. v. U.S. Department of Health and Human Services et al., Case No. 1:12-cv-01592, to the U.S. Court of Appeals for the District of Columbia Circuit (see …
By Kurt R. Karst – Queue up the dueling banjo scene from the film Deliverance. . . . Early last month we saw an interesting press release from Veloxis Pharmaceuticals, Inc. (“Veloxis”) announcing FDA’s October 30, 2014 tentative approval of the company’s 505(b)(2) NDA 206406 for ENVARSUS …
By James E. Valentine* & Anne Marie Murphy – As we previously reported, last month the National Institutes of Health (“NIH”) published a Notice of Proposed Rulemaking on clinical trials registration and results submission (“NPRM”), and is requesting public comment by February 19, 2015. The NPRM generally …
By Kurt R. Karst – December 16th was a good day for Hyman, Phelps & McNamara, P.C. We learned that the U.S. Court of Appeals for the Fourth Circuit handed our client, Mylan Pharmaceuticals, Inc. (“Mylan”), a significant victory. In a 3-0 panel decision (Circuit Judges …
By Karla L. Palmer – On December 4, 2014, in the United States District Court for the District of Tennessee, Main Street Family Pharmacy, LLC and its co-owner David Newbaker each pled guilty to a misdemeanor criminal violation of the Federal Food, Drug, & Cosmetic Act …
By James C. Shehan – Over the past year, the plight of seriously ill patients seeking access to unapproved drugs has led five states to pass laws that permit manufacturers to provide patients in those states with investigational drugs on an emergency basis without going through …
By Kurt R. Karst – 'Tis the season to give back. And that’s exactly what the U.S. Court of Appeals for the Third Circuit did late last week when it vacated and remanded for further proceedings a September 3, 2013 decision from the U.S. District Court …
By Kurt R. Karst – Last Friday, the U.S. Court of Appeals for the Federal Circuit issued its highly anticipated decision in Sandoz Inc. v. Amgen Inc. and Hoffman-La Roche Inc., Case No. 2014-1693 (Fed. Cir. 2014). The case involves two patents Roche licensed to Amgen …
