Pacira Pharmaceuticals filed a lawsuit against the FDA over limitations that prohibit the company from more widely marketing Exparel, a post-surgery pain medication. The FDA had warned the drugmaker in 2014 not to promote the use of Exparel in surgeries other than the procedures for which it had been approved, Reuters reported. The lawsuit cites the recent Amarin decision, which allows that drugmaker to promote some off-label uses of its prescription fish-oil pill, Vascepa.
The prices for a new class of cholesterol-lowering drugs, called PCSK9 inhibitors, need to come down substantially before doctors can recommend them without worrying about their impact on overall healthcare spending, according to The Wall Street Journal. “If the cost is more than $2,177 a year, drug companies, doctors, insurers and other parties may need to work together to determine ways to limit the use of these drugs, find savings in other parts of the healthcare system, or adopt other measures to help make these drugs more affordable,” the Institute for Clinical and Economic Review said in a new report. Sanofi’s and Regeneron’s Praluent runs $14,600 per year and Amgen’s Repatha costs $14,100.
GlaxoSmithKline’s Breo, an inhaled medication, did not prolong life in a trial involving 16,500 patients with chronic respiratory disease, GSK and Theravance announced. Breo lowered the risk of death by 12.2% in the study when compared to a placebo, which is not enough to be seen as statistically significant. Breo was approved in 2013 to treat chronic obstructive pulmonary disease. It is also used to treat asthma.
The FDA said it has concerns about incorrect administration of Collegium Pharmaceuticals’ experimental long-acting opioid painkiller, according to Reuters. The company proposed a label that would say the drug should be taken after eating but that may not be enough to stem concerns about overdoses, the agency said.
Mylan took its six-month-long takeover bid for Perrigo directly to Perrigo shareholders, who will have until Nov. 13 to decide if they will accept Mylan’s latest offer. Perrigo’s senior management has opposed the bid. The $35 billion proposed deal could become the largest hostile takeover in history, reports Fortune.