We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.
In cooperation with Association of Corporate Counsel
  Request new password

Search results

Order by most recent / most popular / relevance

Results: 1-10 of 52

International news: focus on compliance - winter 2014

  • McDermott Will & Emery
  • -
  • China, European Union, Germany, Global, USA
  • -
  • December 2 2014

As regulatory oversight of companiesfrom Sarbanes Oxley and the Dodd-Frank Act to the Foreign Corrupt Practices Act (FCPA) and the UK Bribery

Snapshot of Sunshine rules in EU countries for the pharmaceutical industry part 1 - June 2014

  • McDermott Will & Emery
  • -
  • European Union, United Kingdom
  • -
  • June 12 2014

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. In 2013

Controlling and processing data in EU clinical trials

  • McDermott Will & Emery
  • -
  • European Union
  • -
  • November 22 2010

The legal regime for the conduct of clinical trials of medicinal products for human use in the European Union is set out in Directive 200120EC (the Clinical Trials Directive

European Commission fines pharmaceutical companies for Citalopram pay-for-delay agreements

  • McDermott Will & Emery
  • -
  • European Union
  • -
  • June 30 2013

On 19 June 2013, the European Commission announced a fine of 93.8 million for H. Lundbeck AS (Lundbeck) and a further 52.2 million of fines levied

Repackaging and parallel import of pharmaceutical products

  • McDermott Will & Emery
  • -
  • European Union
  • -
  • May 22 2007

On 27 April 2007, the European Court of Justice (the “ECJ”) handed down yet another decision in the case of Boehringer Ingelheim & others v Swingward Ltd and Dowelhurst Ltd, Case C-34804 (“Boehringer II”

The new EU clinical trials regulation aims at harmonization and transparency

  • McDermott Will & Emery
  • -
  • European Union
  • -
  • October 20 2014

On June 16, 2014, Reg. (EU) No. 5362014 on Clinical Trials on Medicinal Products for Human Use (Regulation) has entered into force. Once it becomes

EMEA and FDA focus on clinical research safety and enforcement

  • McDermott Will & Emery
  • -
  • European Union, USA
  • -
  • August 20 2009

Recent policy changes emphasize the need for sponsoring organizations to be even more vigilant in establishing, updating and monitoring their systems for compliance with clinical research requirements, whether conducted domestically or in a foreign locale

What did you say? $31 million awarded for infringement of hearing aid patent

  • McDermott Will & Emery
  • -
  • European Union
  • -
  • November 29 2012

In a case involving the alleged infringement of two patents related to hearing aids, one of which was found under judgment as a matter of law (JMOL) to not be infringed

Increased European patent protection following a landmark ruling on supplementary protection certificates

  • McDermott Will & Emery
  • -
  • European Union
  • -
  • August 30 2012

The Court of Justice of the European Union (CJEU) rendered judgment relating to a preliminary reference from the English Court of Appeal, holding that the existence of an earlier marketing authorization (MA) of a pharmaceutical product does not preclude the grant of a Supplementary Protection Certificate (SPC) for a different application of the same product

The extent of supply limitation on EU pharmaceutical trade

  • McDermott Will & Emery
  • -
  • European Union
  • -
  • December 16 2008

In its 16 September 2008 judgment, the European Court of Justice (ECJ) gave further guidance on how a dominant pharmaceutical supplier can justify limiting supplies to wholesalers