A New York pharmacist group claims the misuse of “spread pricing” by the state’s pharmacy benefit managers has led to increased drug prices – especially for generics. Source: Drug Industry…
PhRMA picked holes in a proposed Centers for Medicare & Medicaid Services rule increasing Medicare Advantage and Part D plans’ power to negotiate drug prices. Source: Drug Industry Daily
FDA Commissioner Scott Gottlieb on Monday outlined the agency’s plans for promoting the use of real world evidence in clinical trials in 2019. Source: Drug Industry Daily
The FDA denied a petition from Pharmaceutical Manufacturing Research Services (PMRS) asking the agency to set a higher standard for NDAs for abuse-deterrent opioids for treatment of chronic pain. Source:…
Former Insys CEO Michael Babich has agreed to plead guilty in connection with a kickback scheme involving the company’s Subsys fentanyl spray, the U.S. Attorney for the District of Massachusetts…
The European Medicines Agency is seeking public comments as it prepares new guidelines for rare allergy clinical trials. Source: Drug Industry Daily
The stalemate over funding for the federal government continues with no further votes scheduled on Capitol Hill this week. Source: Drug Industry Daily
Canada’s Competition Bureau cleared Celgene, Pfizer and Sanofi of allegedly blocking generic competition, ending a two-year investigation. Source: Drug Industry Daily
The FDA granted orphan status to 26 drugs whose applications didn’t include all required information, , according to a Government Accountability Office report released on Friday. Source: Drug Industry Daily
As part of its efforts to contain the opioid epidemic, the U.S. Attorney for the District of Massachusetts issued warnings to opioid prescribers whose patients died of overdoses. Source: Drug…