Photo credit: Bill Brooks/Creative Commons
1. Democrats are pushing for a subpoena to be issued to Valeant after it refused to submit documents explaining the dramatic price hike of its newly acquired heart drug Nitropress and blood pressure medicine Isuprel. Rep. Elijah Cumming (D-MD) and Sen. Bernie Sanders (I-VT) requested the drugmaker explain in August why the price was raised sixfold for Nitropress and threefold for Isuprel.
2. Hillary Clinton added a new caveat to her drug-cost-lowering proposal, saying drugmakers should fund generic competition of their own products. The Democratic presidential candidate said that the government would take money from drugmakers that don’t spend a minimum amount on research and use that money for grants to generic manufacturers, according to Bloomberg Business.
3. Roche moved closer to securing the first drug to treat progressive multiple sclerosis. The Swiss drugmaker plans to file antibody ocrelizumab with regulators in early 2016, according to Reuters. Roche reported the drug significantly reduced the progression of disability in patients during a Phase-III study.
4. Sanofi’s Lantus may soon see competition from the Eli Lilly/Boehringer Ingelheim drug Basaglar, which has the same amino acid sequence as Lantus. The Associated Press reported that the French drugmaker settled litigation over the patent for its daily insulin injector, Lantus Solostar, allowing Lilly and BI to sell Basaglar in their Kwikpen injector starting December 2016.
5. The FDA dismissed a letter sent by Sen. Angus King (I-ME) and seven other senators criticizing the FDA for approving OxyContin for use in children as young as 11 years old. An FDA spokesperson addressed their remarks, saying that the approval “was not intended to expand or otherwise change the pattern of use of extended-release opioids in pediatric patients.” The spokesperson added, however, that the new approval was meant to set standards for using opioid pain relievers that were already being prescribed off-label, according to the Portland Press Herald.