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HTMLFDA Reports Results of Annual Crack Down on Illegal Internet Pharmacies
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
June 29, 2015, previously published on June 26, 2015
Last week, FDA announced that more than 1,050 websites had illegal drugs and devices seized or received warning letters as part of the Eighth Annual International Internet Week of Action (IIWA). IIWA is an international effort of law enforcement, customs, and regulatory bodies (including FDA, the...

 

HTMLPublic Statements Made by Pharmaceutical and Biotech Company Executives May Raise FDA's Hackles if They Do Not Meet Basic Requirements for Promotional Communications
Joanne S. Hawana; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
June 26, 2015, previously published on June 23, 2015
For players in the highly regulated pharmaceutical and health care industries, it is common knowledge that manufacturers and distributors of FDA-regulated products are required to promote their products in compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and FDA’s...

 

HTMLCalifornia Lawsuit Filed on Behalf Of 12 Injured by Xarelto
Waters Kraus LLP;
Legal Alert/Article
June 18, 2015, previously published on April 22, 2015
Bayer Corp. and Janssen Pharmaceuticals Inc. (a unit of Johnson & Johnson) have been sued in a California lawsuit by 12 people injured from using the companies’ blood thinner Xarelto. The plaintiffs who filed the California lawsuit were taking Xarelto to treat atrial fibrillation or to...

 

HTMLDefactnib Shrinks Size of Mesothelioma Tumors
Waters Kraus LLP;
Legal Alert/Article
June 17, 2015, previously published on May 18, 2015
A clinical trial focused on finding an effective treatment for mesothelioma reportedly is showing encouraging results. The clinical trial involves Defactnib (VS-6063), an Oral Focal Adhesion Kinase Inhibitor developed by the drug maker Verastem, Inc.

 

HTMLFederal Judge Makes Important Ruling in Xarelto Lawsuits
Waters Kraus LLP;
Legal Alert/Article
June 17, 2015, previously published on June 1, 2015
As the number of Xarelto lawsuits rises due to the drug’s link to uncontrollable bleeding in patients, cases filed in federal court have been assigned to a single judge in the Eastern District of Louisiana — Judge Eldon Fallon. In May 2015, Judge Fallon ordered lawyers in the Xarelto...

 

HTMLFDA Puts out Guidance to Require Submissions in ICH’s Electronic Format for Certain Pharmaceutical Product Applications Within Two Years
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
June 16, 2015, previously published on May 2015
The regulator issued guidance in accordance with the FDCA that outlines Electronic Common Technical Document (eCTD) specification requirements for submissions of new drug or biological products, requiring that all submissions be done electronically and in the ICH-developed format within the next...

 

Adobe PDFStrategies in Inter Partes Review Proceedings for Biotech/Pharma Patents
Robert H. Resis; Banner & Witcoff, Ltd.;
Legal Alert/Article
June 2, 2015, previously published on Spring/Summer 2015
In October 2013, about one year after inter partes review (IPR) proceedings became available, the chief judge of the Federal Circuit called the Patent Trial and Appeal Board (PTAB) a “death squad.” Certainly, a high percentage of early IPR petitioners enjoyed success getting the PTAB to...

 

Adobe PDFChallenging and Defending Obviousness at the PTAB
Brittany M. Martinez, Bradley J. Van Pelt; Banner & Witcoff, Ltd.;
Legal Alert/Article
June 2, 2015, previously published on Spring/Summer 2015
In the first two-and-a-half years of inter partes review (IPR) precedent, IPRs have proven to be an effective means of challenging the validity of a patent. More than 73 percent of claims originally challenged in IPR petitions have been either cancelled by the patent owner or found unpatentable by...

 

Adobe PDFThe Supreme Court's Impact on IP Rights in 2015
Jordan N. Bodner, Camille Sauer; Banner & Witcoff, Ltd.;
Legal Alert/Article
June 2, 2015, previously published on Spring/Summer 2015
The U.S. Supreme Court has generated quite a few closely-watched intellectual property decisions in 2014, analyzed in Banner & Witcoff’s Spring and Fall 2014 Newsletters. The trend has continued during the start of the 2014-15 term, with decisions on the appropriate standard for reviewing...

 

HTMLFDA Makes More Electronic Submissions Mandatory
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
June 1, 2015, previously published on May 22, 2015
UPDATE: On May 27, 2015, FDA announced that it was granting additional time for companies to begin submitting electronic postmarketing safety reports for drugs and biologics. Although the effective date for the requirement is June 10, 2015, the Agency is delaying the compliance date until September...

 


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