In our blog post of November 18, 2013 (“No Avoiding BPCIA For Biosimilars: No Patent Declaratory Judgment Before Biosimilars Application is Filed”), we discussed the decision of the U.S. District Court for the Northern...more
There has been a lot of curiosity within the biologics industry regarding how the “patent dance” procedures of the Biologics Price Competition and Innovation Act (“BPCIA”) would operate. This interest was piqued in July 2014...more
FDA Publishes "Purple Book" to Catalog Biologics, Interchangeable and Biosimilar Products -
The US Food and Drug Administration (“FDA”) recently published its first “Lists of Licensed Biological Products with Reference...more
Biologics are large molecules made from, derived from, or extracted from a natural source such as a human, animal, or microorganism that are used in the treatment, diagnosis, or prevention of disease. Biologics include...more
On July 21, 2014, the Health Resources and Services Administration of HHS (HRSA) issued an interpretive rule interpreting Section 340B(e) of the Public Health Service Act as excluding from the 340B Drug Pricing Program orphan...more
Commencing with plan and policy years beginning on or after January 1, 2014, the Affordable Care Act amends the Public Health Service Act (“PHS Act”) to make three important changes to the rules governing health insurance...more
A company that developed a stem cell-based therapy for treating diseases and conditions was found to be in violation of the federal Food, Drug, and Cosmetic Act for failing to seek approval for its product. Cellular and...more
Rule requires most manufacturers to change government pricing methodologies, calculations, and systems.
On July 23, the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human...more
This article highlights some recent developments that employers with Puerto Rico employee benefits arrangements should consider concerning compliance with U.S. federal laws on health care reform and the Patient Protection and...more
A May 10 Wall Street Journal article, “Employers Eye Bare-Bones Health Plans Under New Law” (see the associated video on WSJ Live), highlighted a compliance strategy to minimize employer exposure for assessable payments under...more
Originally published in Tax Management Weekly Report on 11/05/2012.
In a September 27, 2012, front page article, the Wall Street Journal reported that Sears Holdings Corp. and Darden Restaurants, Inc., had adopted a...more
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