The FBI launched an investigation into Johnson & Johnson’s laparoscopic power morcellator, which was used to remove fibroids and is now associated with spreading undetected cancers, reported The Wall Street Journal. The FDA encouraged surgeons not to use the morcellator last year but elevated this alert to a warning in November. The devices were also pulled from the market last year.
Sanofi purchased a priority review voucher from rare-disease drug manufacturer Retrophin for $150 million up front, with an additional $95 million in payments spread out over the next two years. The FDA awards priority-review vouchers to encourage development of drugs for rare diseases. Companies can sell them. Sanofi bought a $67.5-million priority review voucher from BioMarin last July and used it to shorten the review time between its experimental cholesterol-lowering PCSK9 inhibitor and Amgen’s version.
The FDA approved Valeant’s antibiotic Xifaxan for irritable bowel syndrome. The drug was part of Valeant’s $11-billion Salix acquisition, which closed earlier this year. Jefferies analyst David Steinberg said in a research note that the company kept Salix’s gastrointestinal sales force intact so it could quickly launch the drug with the expanded indication. He estimates peak sales could reach $1 billion.
Zogenix expects to file fenfluramine for the rare pediatric seizure disorder Dravet syndrome with the FDA late next year, reported the Associated Press. Fenfluramine is the “fen” component of the obesity medication fen-phen, which the FDA pulled from the market in 1997 because of heart-valve damage. The other component in fen-phen is phentermine, which is on the market.
Generic drug prices are falling … slowly but prices for 27% of the most commonly used generics actually went up in 2013, according to a report by AARP’s Public Policy Institute. AARP researchers said retail generic drug prices fell by an average of 4% in 2013, which is the lowest decrease since 2006. AARP’s concern: 66% of older patients use at least three prescriptions a year and the $850 those patients spent on retail drug costs on average in 2013 is higher than it was eight years ago, but a Drug Store News report indicates the concern may be too late. A study by the University of Michigan and Johnson & Johnson found old-age health problems begin to pop up by age 45.