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

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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 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...

 

HTMLFDA Releases Draft Guidance on Section 503B Fees for Drug Compounding Outsourcing Facilities; Details Process for Paying and Calculating Fees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On April 1, 2014, the U.S. Food and Drug Administration (FDA) published notice of its Draft Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act ("Draft Guidance"), which sets forth FDA's current thinking on the...

 

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...

 

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...

 

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...

 

HTMLLimitations Imposed on Use of FDA Warning Letters
Anne K. Walsh; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
March 28, 2014, previously published on March 25, 2014
The Supreme Court of Arkansas recently overturned a lower court’s $1.2 billion award to the State of Arkansas, and also reversed and remanded the decision granting over $200 million in attorney’s fees and costs to the state. Putting aside the huge dollar figures at stake for Johnson...

 

HTMLPerrigo Sues FDA Over Failure to Grant Therapeutic Equivalence Rating for Testosterone Gel 505(b)(2) NDA
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
March 28, 2014, previously published on March 23, 2014
In a Complaint filed last Friday in the U.S. District Court for the District of Columbia, Perrigo Israel Pharmaceuticals Ltd. and Perrigo Company (collectively “Perrigo”) (represented by Hyman, Phelps & McNamara, P.C.) allege that FDA has shirked a duty under the Federal Food, Drug,...

 

HTMLFTC Targets Reporting of Licensing of Pharmaceutical Patents With Special Rules for Premerger Notification: What You Need to Know
Peter S. Reichertz; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
March 25, 2014, previously published on March 19, 2014
On November 15, 2013, the Federal Trade Commission (“FTC”) adopted special rules for determining whether “exclusive” licenses of pharmaceutical patents are required to be reported to the FTC and the Antitrust Division of the Department of Justice under the Hart-Scott-Rodino...

 


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