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Late to the party: EEOC proposes wellness program regulations - McguireWoods healthcare reform guide: installment No. 50
  • McGuireWoods LLP
  • USA
  • May 28 2015

This is the 50th in a series of WorkCite articles concerning the Patient Protection and Affordable Care Act and its companion statute, the Health


Actavis loses Nameda appeal over “hot documents”
  • McGuireWoods LLP
  • USA
  • May 29 2015

The U.S. Court of Appeals for the Second Circuit's opinion (issued May 22, 2015 with a public, redacted version available May 28, 2015), affirming


Biological v. biosimilar: “860 is the magic burden per response number for now
  • McGuireWoods LLP
  • USA
  • February 4 2015

On February 3, 2015, FDA published a notice in the Federal Register requesting comments on information collection in an application for a proposed


Amarin wins truthful off-label speech challenge
  • McGuireWoods LLP
  • USA
  • August 10 2015

On August 7, Citing the First Amendment, a Southern District of New York court ruled that FDA cannot limit a manufacturer's "truthful and


NaviMed Capital closes new $110 million healthcare PE fund
  • McGuireWoods LLP
  • USA
  • July 20 2015

NaviMed Capital has announced the closing of its inaugural healthcare private equity fund, NaviMed Partners, LP. The fund has more than $110 million


Hospital’s cloud-based document-sharing practices lead to $218,400 HIPAA settlement
  • McGuireWoods LLP
  • USA
  • July 21 2015

On July 10, 2015, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced a substantial settlement with St


Look Before You Leap: Cautionary Tale of a Non-Reportable Transaction
  • McGuireWoods LLP
  • USA
  • November 29 2016

The list of non-reportable transactions challenged after the fact by the Department of Justice and the Federal Trade Commission continues to grow


Weekly Washington healthcare update - February 16, 2015
  • McGuireWoods LLP
  • USA
  • February 16 2015

Energy and Commerce Hearing Examines ICD-10 Preparedness... HHS Announces Oncology Care Model Initiative... Pennsylvania Governor Abandons


First U.S. biosimilar Zarxio (filigrastim-sndz) approved: issues remain
  • McGuireWoods LLP
  • USA
  • March 6 2015

On March 6, 2015, FDA approved the first biosimilar under the Biologics Price Competition and Innovation Act (BPCIA), Sandoz’s Zarxio. Sandoz


Weekly Washington healthcare update - April 20, 2015
  • McGuireWoods LLP
  • USA
  • April 20 2015

Energy and Commerce Health Subcommittee Explores Post-Acute BundlingCMS Releases First-ever Hospital Compare Star RatingsFiscal Year 2016 Proposed