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

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HTMLE-Commerce Sector Inquiry Finds Widespread Geo-Blocking in the EU
Bernard E. Amory, Charlotte Breuvart, Yvan N. Desmedt, Tristan J. Verminck; Jones Day;
Legal Alert/Article
April 26, 2016, previously published on April 2016
In its ongoing sector inquiry into e-commerce in the European Union, the European Commission has published its initial findings on geo-blocking. Launched in May 2015 by the European Commissioner in charge of competition, Margrethe Vestager, this inquiry forms part of the Commission-wide Digital...

 

Adobe PDFAlabama No Longer an Outlier State: Legislature Says “No” to Innovator Liability
Christopher S. Berdy, John H. Dollarhide, Ashley Nader Stubbs; Butler Snow LLP;
Legal Alert/Article
January 21, 2016, previously published on Fall 2015
Since the United States Supreme Court’s decision in Pliva, Inc. v. Mensing1, the plaintiffs’ bar has been feverishly searching for an alternate theory of recovery when the claimant took a generic prescription drug. One of those alternate theories is “innovator liability,”...

 

HTMLFDA Provides Additional Warnings for SGLT2 Inhibitors
Law Offices of Peter G. Angelos A Professional Corporation;
Legal Alert/Article
December 10, 2015, previously published on December 7, 2015
In May, the United States Food and Drug Administration released information advising physicians and patients to be cautious about the risks related to SGLT2 inhibitors. Now, the FDA has updated the warning label for the drugs to include the risk of ketoacidosis and severe urinary tract infection.

 

HTMLFDA Publishes Revised Guidance on Product Tracing Requirements for Dispensers
Carolyn A. Alenci, Rachael G. Pontikes; Duane Morris LLP;
Legal Alert/Article
November 30, 2015, previously published on November 4, 2015
On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) was enacted “to build an electronic, interoperable system by November 27, 2023, which will identify and trace certain prescription drugs as they are distributed in the United States.” This year, trading partners were...

 

HTMLFDA Holds Back-to-Back Workshops on Next-Generation Sequencing Diagnostic Tests
Edgar J. Asebey, Maureen Bennett, Christian B. Fulda, Colleen Heisey, Cristiana Spontoni; Jones Day;
Legal Alert/Article
November 27, 2015, previously published on November 2015
Last week, FDA held two workshops to gather information on developing a flexible approach for the regulation of next generation sequencing ("NGS") in vitro diagnostic tests. NGS tests facilitate the rapid sequencing and analysis of segments of DNA, yielding information that can be used to...

 

HTMLFTC Urges FDA to Rethink Its Biosimilar Naming Proposal; Other Stakeholders Agree
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
Legal Alert/Article
November 10, 2015, previously published on November 4, 2015
The Federal Trade Commission (FTC) last week disputed the effectiveness and competitive impact of the Food and Drug Administration’s recently proposed biosimilar naming policy and argued that using different nonproprietary names for biosimilars as compared to their reference biologics would...

 

HTMLMesothelioma Drug Fails in Phase II Testing
Waters Kraus LLP;
Legal Alert/Article
October 26, 2015, previously published on October 14, 2015
A mesothelioma drug that once held promise for patients and their families has failed to live up to everyone’s hope. In a phase II clinical trial, defactinib (VS-6063) proved to be no more effective than a placebo.

 

HTMLXarelto Dangers Investigated in Canada
Waters Kraus LLP;
Legal Alert/Article
October 26, 2015, previously published on October 12, 2015
The Canadian government has recently initiated a probe into the dangers associated with the blood thinner Xarelto (rivaroxaban). In July 2011, the U.S. Food & Drug Administration (FDA) approved the anti-clotting agent for patients receiving knee and hip replacements, to prevent strokes. Later...

 

HTMLFDA Draft Guidance Describes Procedures, Policies for Resolving Scientific and Medical Disputes
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
October 19, 2015, previously published on September 2015
The agency issued guidance on the resolution of disputes that arise from disagreements between sponsors and the CDER or CBER, going over the procedures in the CDER and CBER for resolving scientific and/or medical disputes that can’t be settled at the decision level.

 

HTMLPacira Sues FDA, Alleging It Illegally Attempted to Restrict Truthful and Non-Misleading Speech about Its Post-Surgery Pain Drug Exparel
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
October 19, 2015, previously published on September 2015
The drugmaker filed a First Amendment suit seeking an injunction to prevent the regulator from taking enforcement action against it over what Pacira says is truthful and non-misleading promotion of Exparel, and alleging the FDA retroactively attempted to revise the drug’s label to limit its...

 


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