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HTMLRemedies Proposed in UK Retail Banking Sector to Address Lack of Competition
Alan Davis, Matt Evans; Jones Day;
Legal Alert/Article
October 28, 2015, previously published on October 2015
The UK Competition and Markets Authority (“CMA”) has provisionally concluded there is a lack of effective competition in the UK retail banking market and has proposed a number of remedies to improve customers’ knowledge and awareness, encourage them to switch providers, and make...

 

HTMLFDA Indicates Shared Nonproprietary Names Not Appropriate for All Biological Products, Including Biosimilars
Edgar J. Asebey, Maureen Bennett, Colleen Heisey, Janet M. McNicholas, Christian Paul; Jones Day;
Legal Alert/Article
September 11, 2015, previously published on September 2015
On August 28, 2015, the U.S. Food & Drug Administration ("FDA") released a draft guidance document describing its current position on biological product nonproprietary naming, including the need for biological products to bear a nonproprietary name to which is attached an...

 

HTMLOPDP Warns Duchesnay over Kim Kardashian’s Social Media Endorsement of Morning Sickness Drug
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
September 1, 2015, previously published on August 2015
The regulator issued a warning letter stating Kardashian’s endorsement of the company’s Diclegis pill on social media was misleading because she failed to include risk information and limitations of use.

 

HTMLCourt Prohibits FDA from Bringing Charges against Drugmaker Amarin for Promoting Fish Oil Drug for Off-Label Uses
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
September 1, 2015, previously published on August 2015
A New York federal judge granted Amarin’s bid for “preliminary relief,” allowing the drugmaker to promote its Vascepa pill for off-label use without the threat of an FDA misbranded action, as long as its communications are truthful and nonmisleading.

 

HTMLFDA Revises Draft Guidance on Brief Summary and Adequate Directions for Use in DTC Print Ads and Promotional Labeling for Prescription Drugs
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
September 1, 2015, previously published on August 2015
In a bid to give consumers better and more actionable information, the regulator revised recommendations for disclosing risk information in DTC prescription drug ads and promotional labeling in print media as it relates to the brief summary requirement and the requirement that adequate directions...

 

HTMLFDA Guidance Explains How the Agency Will Determine Whether a 510(K) Submission Should Be Accepted for Substantive Review
Scott S. Liebman; Loeb & Loeb LLP;
Legal Alert/Article
September 1, 2015, previously published on August 2015
The regulator issued guidance to go over the necessary elements and contents of a complete 510(k) submission in a bid to enhance the consistency of acceptance decisions.

 

HTMLCourt Finds Swap Agreement and Underlying Lease Agreement Are Not Severable
Philippe Goutay, Anselme Mialon; Jones Day;
Legal Alert/Article
June 26, 2015, previously published on June 2015
In a decision dated January 20, 2015, the Paris Court of Appeal confirmed an earlier decision held by a lower court in a case involving a floating rate lease agreement and a swap contract.

 

HTMLMembers of the Securities Regulator and the Enforcement Committee Issue Proposals on Dual Enforcement of Market Abuses
Philippe Goutay, Anselme Mialon; Jones Day;
Legal Alert/Article
June 26, 2015, previously published on June 2015
As previously reported, recent case law requires amending rules providing for the dual enforcement of market abuses both by the enforcement body of the securities regulator and criminal courts.

 

HTMLProvisions Applying to French Branches of Non-EU Credit Institutions Are Revised
Philippe Goutay, Anselme Mialon; Jones Day;
Legal Alert/Article
June 26, 2015, previously published on June 2015
Pursuant to Article 47(1) of CRD IV, Ordinance no. 2015-558 dated May, 21, 2015 amended with immediate effect the provisions applying to French branches of non-EU credit institutions.

 

HTMLPosition Limits and Reporting on Commodity Derivatives to Take Effect Next Month
Philippe Goutay, Anselme Mialon; Jones Day;
Legal Alert/Article
June 26, 2015, previously published on June 2015
Beyond providing for a French regime of banking separation, French Law no. 2013-672 of July 26, 2013 had sought to anticipate MiFID 2 on a number of issues. Among such issues, starting from July 1, 2015, the Autorité des Marchés Financiers ("AMF") will be empowered to impose...

 


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