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Pharma Groups Denied Restraining Order in Nevada Drug Pricing Lawsuit
Judge James C. Mahan of the US District Court denied the Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Innovation Organization (BIO)’s motion for a temporary restraining order that would force Nevada to “cease and desist all action implementing or enforcing” contested sections of Nevada’s Senate Bill 539.
Judge James C. Mahan of the US District Court denied the Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Innovation Organization (BIO)’s motion for a temporary restraining order that would force Nevada to “cease and desist all action implementing or enforcing” contested sections of Nevada’s Senate Bill (SB) 539.
SB 539, signed into law by Republican Governor Brian Sandoval, requires drug makers to annually disclose list prices for insulins, profits made, and discounts provided to pharmacy benefit managers. It also requires drug makers to explain spikes in insulin pricing. Trade groups PhRMA and BIO called the drug “unprecedented” and “unconstitutional.”
In his decision, Mahan indicated that the court could rule a temporary restraining order only if the moving party showed that immediate and irreparable loss or damage would result before the opposing party’s motion for a preliminary injunction could be heard. He called such a restraining order an “extraordinary remedy” that would not be granted without the plaintiff’s demonstrating the possibility of irreparable. Mahan said that PhRMA and BIO had not shown that they would suffer such damage, in part because the first disclosures from industry concerning drug pricing will not be due until July of 2018.
Now that the motion for the restraining order has been denied, the state will have until September 27, 2017 to file its reply to PhRMA and BIO’s motion for preliminary injunction.
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
BioRationality: Commemorating the 15th Anniversary of the BPCIA
April 8th 2025Affirming that analytical characterization is often sufficient for biosimilar approval, minimizing unnecessary clinical testing, and enhancing FDA-led education to counter stakeholder misconceptions are key recommendations put forth in this opinion piece by Sarfaraz K. Niazi, PhD.
