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Results: 1-10 of 1,163

Judge upholds poaching claims in pharmaceutical data antitrust case
  • McDermott Will & Emery
  • USA
  • August 22 2014

On Friday, August 15, 2014, Judge Gerald McHugh of the Eastern District of Pennsylvania let stand several counterclaims that IMS Health Inc


Physicians write letter to FDA regarding biosimilar naming concerns
  • McDermott Will & Emery
  • USA
  • August 25 2014

On Thursday, August 14, 2014, several physicians wrote a letter to Commissioner Hamburg of the U.S. Food and Drug Administration (FDA) expressing


Sham-wow! antitrust liability may attach to sham administrative petitions
  • McDermott Will & Emery
  • USA
  • October 1 2014

Addressing whether the “sham” exception to Noerr-Pennington immunity is limited to sham litigation in courts, the U.S. Court of Appeals for the


Silence of ANDA with respect to a claim limitation does not constitute infringement
  • McDermott Will & Emery
  • USA
  • October 1 2014

In Hatch-Waxman litigation that involved Abbreviated New Drug Applications (ANDAs) that were silent as to certain claimed limitations, the U.S. Court


Focus on regulatory law - October 2014
  • McDermott Will & Emery
  • France
  • October 3 2014

The applicant claimed that the provisions of I, Article L. 430-8 of the French Commercial Code, which allows the Competition Authority to fine


Just in time for the holidays: another HIPAA settlement
  • McDermott Will & Emery
  • USA
  • December 11 2014

On December 2, 2014, the Office for Civil Rights (OCR) and Anchorage Community Mental Health Services, Inc., (ACMHS) entered into a Resolution


FDA issues draft guidance on communications over internet and social media platforms
  • McDermott Will & Emery
  • USA
  • July 22 2014

On June 17, 2014, the U.S. Food and Drug Administration (FDA or the Agency) issued two draft guidance documents, providing recommendations for two


Generic drug and API producers deal with the Bolar exemption
  • McDermott Will & Emery
  • Germany
  • February 26 2014

To allow generic drug companies to enter the market as seamlessly as possible after expiration of patent rights, the Bolar exemption allows certain


CMS proposes to restrict diagnoses from home visits for Medicare Advantage risk adjustment
  • McDermott Will & Emery
  • USA
  • February 25 2014

The Centers for Medicare and Medicaid Services has proposed to limit how Medicare Advantage Organizations can use in-home wellness or risk assessment


Commission publishes fourth monitoring report on pharmaceutical patent settlements
  • McDermott Will & Emery
  • European Union
  • February 11 2014

The European Commission has published its fourth Report on the Monitoring of Patent Settlements (the report), concerning pharmaceutical patent