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Documents on Antitrust & Trade Regulation, Pharmaceuticals, Internet & E-Commerce
 

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HTMLThe Cybersecurity Race: Executive Branch Takes The Lead While Congress Watches From The Bleachers
Alexander W. Major; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
April 22, 2014, previously published on April 18, 2014
The federal government sector has been abuzz lately with whispers and shouts about pending cybersecurity regulations, frameworks, and requirements. This attention is not particularly surprising, especially given the recent high-profile data breaches, the litigation threats surrounding those...

 

HTMLZogenix Prevails in Initial Challenge to Massachusetts Emergency Order Banning ZOHYDRO ER
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
April 21, 2014, previously published on April 16, 2014
When we first heard about the Complaint and Motion for Preliminary Injunction Zogenix, Inc. filed against Massachusetts Governor Deval Patrick, among others, alleging that the Commonwealth’s ban on FDA-approved ZOHYDRO ER (hydrocodone bitartrate) Extended-release Capsules is unconstitutional...

 

HTMLFTC Continues Aggressive Posture on Reverse Payment Settlement Agreements with Reference to Disgorgement
Andrew J. Forman, Daniel J. Howley, Jessica Michaels, Charles F. (Rick) Rule; Cadwalader, Wickersham & Taft LLP;
Legal Alert/Article
April 20, 2014, previously published on April 3, 2014
In two recent statements, the FTC reaffirmed its intention aggressively to pursue reverse-payment patent settlement agreements in the pharmaceutical industry.

 

HTMLFDA Seeks Information for Implementation of Drug Supply Chain Security Act
Duane Morris LLP;
Legal Alert/Article
April 15, 2014, previously published on April 11, 2014
On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) was enacted "to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within the United States." To accomplish this, the U.S. Food and Drug Administration (FDA) is...

 

HTMLGPhA Calls for US-EU Convergence in Biosimilar and Generic Medicine Regulation
James C. Shehan; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
April 15, 2014, previously published on April 10, 2014
The Generic Pharmaceuticals Association (“GPhA”) opened a new front in its ongoing battle to shape the approval process for biosimilars, while also calling for more cooperation between the US and the EU in their oversight of traditional generic drugs. In a joint letter to the European...

 

HTMLFDA Releases Draft Guidance on Section 503B Fees for Drug Compounding Outsourcing Facilities; Details Process for Paying and Calculating Fees
Duane Morris LLP;
Legal Alert/Article
April 14, 2014, previously published on April 7, 2014
On April 1, 2014, the U.S. Food and Drug Administration (FDA) published notice of its Draft Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act ("Draft Guidance"), which sets forth FDA's current thinking on the...

 

HTMLAnother REMS Antitrust Lawsuit: Mylan Sues Celgene Over THALOMID and REVLIMID to Obtain Drug Product Sample
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
April 11, 2014, previously published on April 4, 2014
In a 17-count, 84-page Complaint filed earlier this week in the U.S. District Court for the District of New Jersey, Mylan Pharmaceuticals Inc. (“Mylan”) alleges that Celgene Corporation (“Celgene”) has violated federal and state antitrust laws by preventing generic...

 

HTMLPinterest Contest Draws FTC Warning
Barry M. Benjamin, Lindsay A. Victor; Kilpatrick Townsend & Stockton LLP;
Legal Alert/Article
April 11, 2014, previously published on April 8, 2014
A Pinterest contest conducted by Cole Haan, Inc. recently resulted in an FTC warning. Shoe company Cole Haan held a contest via Pinterest that required contestants to create a board entitled “Wandering Sole.” Contestants then had to pin at least five images from Cole Haan’s...

 

HTMLMaryland District Court Dismisses Qui Tam Action Against Pharmaceutical Drug Manufacturers Under the Heightened Pleading Standards of the False Claims Act
Jhanelle A. Graham; Semmes Bowen Semmes A Professional Corporation;
Legal Alert/Article
April 10, 2014, previously published on March 2014
In United States, et al., ex rel. Jerome Palmieri v. Alpharma, Inc., et al., the relator, Jerome Palmieri, filed a qui tam action on behalf of the United States of America and various individual states (collectively, the "Qui Tam States") against his employers, Alpharma, Inc. and Alpharma...

 

HTMLFDA Begins Implementation of the Drug Supply Chain Security Act: Calls for Comments and a Workshop
William T. Koustas; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
April 4, 2014, previously published on April 2, 2014
FDA has begun its efforts to implement the Drug Supply Chain Security Act (“DSCSA”), also known as Title II of the Drug Quality and Security Act. As we have reported in prior posts (here and here), the DSCSA requires FDA to issue a series of guidance documents and hold public meetings...

 


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