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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.

 

HTMLWhat’s Really in Your Supplements?
Selina A. Billington; Wilson Elser Moskowitz Edelman & Dicker LLP;
Legal Alert/Article
April 15, 2015, previously published on March 16, 2015
New York State Attorney General’s Investigation Has Sparked a Coalition of State Attorneys General Against Herbal Supplement Manufacturers: What does this mean for the industry as a whole in terms of product liability exposure?

 

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...

 

HTMLJ&J and Bayer Launch New Xarelto Study
Waters Kraus LLP;
Legal Alert/Article
April 7, 2015, previously published on March 20, 2015
Johnson & Johnson and Bayer are reportedly seeking additional Food and Drug Administration (FDA) approval for Xarelto, the companies’ lucrative blood thinner that many lawsuits claim can cause injuries and death from uncontrollable bleeding.

 

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...

 

HTMLLawyer in Vietnam Oliver Massmann Pharmaceutical Market
Oliver Massmann; Duane Morris Vietnam LLC;
Legal Alert/Article
March 30, 2015, previously published on January 26, 2015
Vietnam’s healthcare system is currently in general on the move due to the economic growth and the rapid development.

 

HTMLOmnicare Opinion Expands Liability for Expressions of Opinion Under Section 11
Brittany M. Cambre, Samuel J. Casey, Patricia A. Gorham, Joel J. Hughey, Peter Ligh; Sutherland Asbill & Brennan LLP;
Legal Alert/Article
March 26, 2015, previously published on March 25, 2015
The Supreme Court, in Omnicare, Inc. v. Laborers District Council Construction Industry Pension Fund, 575 U.S. --- (March 24, 2015), expanded the scope of liability for expressions of opinions under Section 11 of the Securities Act of 1933. While keeping to a relatively constrained view of the...

 


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