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On Thursday, June 13, the Supreme Court of the United States issued three decisions: FDA v. Alliance for Hippocratic Medicine, No. 23-235: This case involves an attempt to rescind the Food and Drug Administration’s...more
Does your company's health plan provide prescription drug coverage? If so, you have until October 15, 2023 to send a notice to individuals who are enrolled in Medicare Part A or Part B and are eligible for the company's...more
Does your company's health plan provide prescription drug coverage? If so, you have until October 15, 2022 to send a notice to individuals who are enrolled in Medicare Part A or Part B and are eligible for the company's...more
The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform signed into law by President Obama in March 2010. This year, the BPCIA turns 10. While the U.S. Biosimilars Pathway has...more
We recognize that many of our clients sponsor ERISA welfare benefit plans and are currently undergoing their open enrollment process and issuing related participant communications. To assist our clients with that process, we...more
FCA overturns cefaclor damages decision on prejudgment interest issue, provides guidance on NIA defence - On November 23, 2018, the Federal Court of Appeal (FCA) allowed in part Apotex’s appeal of a decision awarding Eli...more
On March 1, 2018, the U.S. Food and Drug Administration (FDA) issued two new draft guidances which further the FDA’s implementation of the Drug Supply Chain Security Act (DSCSA). The DSCSA amended the Federal Food, Drug, and...more
Pharmaceutical industry stakeholders know that drug prices, market competition, supply chain challenges, and shortages of critical drug products have been top of mind for policymakers in recent years. Among others tackling...more
With the U.S. biosimilar pathway created by the Biologics Price Competition and Innovation Act (BPCIA) now fully up and running, there are now seven ongoing biosimilar litigations in the U.S. Here are brief updates on recent...more
On June 9, 2016, California’s End of Life Option Act (the “Act”) will go into effect. The Act authorizes an adult who is suffering from a terminal disease and meets other qualifications to request an aid-in-dying drug that...more
On October 6th, California’s governor signed Senate Bill 671, which permits pharmacists to substitute an interchangeable biological product for a prescribed biological product. The California legislature had attempted to pass...more
As we have been reporting this week, the Federal Circuit handed down its decision in Amgen Inc. v. Sandoz Inc. -- a case of first impression relating to the Biologics Price Competition and Innovation Act ("BPCIA") for...more
On July 21, the Federal Circuit interpreted the patent litigation procedures and requirements of the Biologics Price Competition and Innovation Act (BPCIA), including whether a company submitting an abbreviated BLA (“k...more
Yesterday, we noted that the Generic Pharmaceutical Association (GPhA) recently expressed its opposition to a California bill (SB-598) that would authorize a pharmacist to select a biosimilar when filling a prescription order...more
Last week, the Generic Pharmaceutical Association (GPhA) released a statement regarding a California bill (SB-598) that the GPhA asserted would "introduce[] burdensome provisions that could raise costs and limit patient...more