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Documents on pharmaceuticals

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HTMLALJ Essex Sets Procedural Schedule In Certain Beverage Brewing Capsules (337-TA-929)
Eric W. Schweibenz; Oblon, Spivak, McClelland, Maier & Neustadt, L.L.P.;
Legal Alert/Article
October 23, 2014, previously published on October 20, 2014
On October 17, 2014, ALJ Theodore R. Essex issued Order No. 7 in Certain Beverage Brewing Capsules, Components Thereof, and Products Containing the Same (Inv. No. 337-TA-929).


HTMLSame-Sex Marriage Recognized in West Virginia - How Will This Impact Employer-Sponsored Health Plans?
Jill E. Hall; Bowles Rice LLP;
Legal Alert/Article
October 22, 2014
Today, the Attorney General and Governor of the State of West Virginia announced that West Virginia will no longer prohibit same-sex marriage, implementing a ruling of the United States Court of Appeals for the Fourth Circuit (the federal appeals court that encompasses West Virginia, Virginia,...


HTMLFDA Fast-Tracking Experimental Drugs
McDonald Hopkins LLC;
Legal Alert/Article
October 22, 2014, previously published on October 17, 2014
The development of a pharmaceutical drug is a slow, deliberate process, and it can take years of back-and-forth between scientists and health officials before medicine makes it to the market.


HTMLFront End Changes and, Again, More DIR Columns
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
October 21, 2014, previously published on October 17, 2014
Since the beginning of the Medicare Part D program, CMS has introduced many reporting mechanisms for trying to understand drug pricing, price concessions, and the cost of providing services to Part D members. The tool CMS has turned to most often is the direct and indirect remuneration...


HTMLFederal Circuit Jurisdiction Over Patent Contract Disputes
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
October 15, 2014, previously published on October 9, 2014
In a precedential order issued in Jang v. Boston Scientific Corp., the Federal Circuit held that it has jurisdiction over the parties’ patent-related contract dispute under Gunn v. Minton even though the patents at issue have been invalidated. Despite having found Federal Circuit...


HTMLOIG Issues Special Advisory Bulletin and Report Emphasizing Prohibition on Copay Coupons for Federally Reimbursable Medications (Including Part D Covered Drugs), Notes Potential Antikickback Violations
Loeb Loeb LLP;
Legal Alert/Article
October 14, 2014, previously published on September 2014
According to the OIG, “Pharmaceutical manufacturers that offer copayment coupons may be subject to sanctions if they fail to take appropriate steps to ensure that such coupons do not induce the purchase of Federal health care program items or services.”


HTMLFederal Circuit Hears Arguments in Other Myriad Gene Patents Case
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
October 13, 2014, previously published on October 7, 2014
On October 6, 2014, the Federal Circuit heard oral arguments in a case involving the claims of the Myriad gene patents that were not invalidated by the Supreme Court’s 2013 decision. The Federal Circuit is reviewing the district court’s denial of Myriad’s motion for a preliminary...


HTMLEEOC Files Suit over Common Severance Agreement Language
Joseph F. Spitzzeri; Johnson & Bell, Ltd.;
Legal Alert/Article
October 8, 2014, previously published on September 2014
On February 7, 2014, the Chicago Office of the Equal Employment Opportunity Commission (EEOC) filed a lawsuit against CVS Pharmacy, Inc. alleging its separation agreements violate Section 707 of the Civil Rights Act of 1964. The Chicago office is widely recognized as the most aggressive of the...


HTMLCanada and the EU Successfully Conclude CETA: What It Means to the Pharmaceutical Industry
Steven Mason, Sanjaya Mendis; McCarthy Tétrault LLP;
Legal Alert/Article
October 7, 2014, previously published on October 2, 2014
On September 26, 2014, Prime Minister Harper announced that Canada and the European Union have successfully concluded negotiations on a new trade agreement, the Comprehensive Economic and Trade Agreement (CETA) that was five years in the making, and publicly released the consolidated text of the...


HTMLDEA Releases Final Rule on Disposal of Controlled Substances
Duane Morris LLP;
Legal Alert/Article
October 3, 2014, previously published on September 26, 2014
On September 9, 2014, the U.S. Drug Enforcement Administration (DEA) released notice of a final rule governing the disposal of controlled substances (the "Final Rule"). The Final Rule implements the Secure and Responsible Drug Disposal Act of 2010 (the "Disposal Act"), and...


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