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HTMLFDA Warns Nanobiotech Pharma for Using Metatags and Social Media to Make Improper Claims about Its Products
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
April 22, 2015, previously published on March 2015
The regulator sent a warning letter to the life science company for using metatags to supplement the improper promotion of its products as drugs, as well as making unapproved claims on Facebook, LinkedIn and its website.

 

HTMLOPDP Sends Warning Letter to UCLA for Promoting Investigational New Drug on Taumark Website
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
April 22, 2015, previously published on March 2015
The regulator warned UCLA, a partner in TauMark and the sponsor of the investigational new drug FDDNP, that it is violating the FD&C Act by promoting the brain diagnostic drug without market authorization and by failing to include adequate directions for use.

 

HTMLOPDP Warning Letter States That Discovery Laboratories’ Website for Surfaxin Makes Unsubstantiated Superiority Claims, Lacks Adequate Directions for Unapproved Use
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
April 22, 2015, previously published on March 2015
Discovery Laboratories was warned by the regulator after a review of its website revealed that the company made unsupported superiority claims about Surfaxin as well as claims indicating that the RDS-prevention drug is intended for a use for which it lacks approval and for which its labeling fails...

 

HTMLFDA Approves Novartis’ Zarxio As The First Biosimilar In The U.S., Clearing The Drug For The Same Indications As Neupogen And Giving It A Placeholder Nonproprietary Name
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
April 22, 2015, previously published on March 2015
The regulator granted a landmark approval to the copycat version of the already approved drug in the U.S., opening up the market to less expensive copies of biological products, while uncertainty related to a naming policy remains.

 

HTMLFDA Issues New Documents Governing Drug Compounding
Patrick C. Gallagher, Rachael G. Pontikes, Alison T. Rosenblum; Duane Morris LLP;
Legal Alert/Article
April 14, 2015, previously published on April 6, 2015
The first few months of 2015 have proven very active for the U.S. Food and Drug Administration (FDA) and its regulation of pharmaceutical compounding. On February 13, 2015, FDA announced the release of five new documents related to drug compounding and repackaging. The documents provide further...

 

HTMLHospital Wins First Round Against Largest Rival in Antitrust Suit Alleging Illegal Exclusive Dealing Agreements with Insurers
Robert G. Kidwell, Dionne C. Lomax, Farrah Short, Bruce D. Sokler; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
April 6, 2015, previously published on March 30, 2015
The waves of change affecting health care providers include reimbursement and funding developments, the impact of the Affordable Care Act, technological and medical advances, provider network design transformations imposed by payors — and antitrust. The Federal Trade Commission’s...

 

HTMLPay-For-Delay In 2014: Courts Fill In The Actavis Gaps
Jonathan Mark Watkins; Zelle Hofmann Voelbel & Mason LLP;
Legal Alert/Article
April 6, 2015, previously published by Competition Law360 on December 19, 2014
A little more than one year ago, the U.S. Supreme Court decided Federal Trade Commission v. Actavis Inc. and affirmed that antitrust principles apply to reverse payment settlement agreements — those in which a brand-name drug manufacturer pays a potential generic competitor to settle a patent...

 

HTMLFTC Tastes Sweet Victory in POM Wonderful Deceptive Advertising Appeal
Timothy J. Slattery; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
March 30, 2015, previously published on February 17, 2015
The District of Columbia Circuit Court of Appeals handed the Federal Trade Commission a critical win on January 30, 2015 by affirming the Commission’s January 2013 decision holding POM Wonderful LLC in violation of the FTC Act for its deceptive advertisements alleging pomegranate juice and...

 

HTMLNinth Circuit Affirms FTC’s Challenge to Hospital-Physician Group Merger, While Rejecting Efficiencies and Health Care Quality Arguments
Robert G. Kidwell, Dionne C. Lomax, Farrah Short, Bruce D. Sokler; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
March 30, 2015, previously published on February 11, 2015
In a much anticipated appellate health care antitrust decision, the United States Court of Appeals for the Ninth Circuit upheld a district court’s finding that a consummated hospital-physician group merger violated Section 7 of the Clayton Act, despite the provider-defendants’ assertion...

 

HTMLDOJ Releases Electrifying New Guidance on Standard-Essential Patent Policy
Timothy J. Slattery, Bruce D. Sokler; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
March 30, 2015, previously published on February 10, 2015
The Department of Justice (the “Department” or “DOJ”) continued its multi-pronged defense of standards-setting organizations (SSOs) who adopt patent policies to prevent hold-up during licensing negotiations. Last week’s business review letter is just the latest of...

 


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