Good morning, everyone, and welcome to yet another busy day. As always, the to-do list is growing quickly as we try to keep track of things to peruse and people to contact and then figure out what gets done first. Sounds familiar, yes? This calls for another cup of stimulation. So please join us as fire up the coffee kettle and dig in. Meanwhile, here are your tidbits. Hope you have a lovely day and keep in touch …
Martin Shkreli and Howard Schiller, the Valeant Pharmaceuticals interim chief executive, appear today at a House committee hearing on drug pricing, which you can watch here. Shkreli is expected to take the Fifth, while Schiller will be grilled on Valeant pricing practices. Also appearing will be Food and Drug Administration official Janet Woodcock to explain how the agency is grappling with a backlog of applications for generic drug approvals. STAT has more background.
At the hearing, Schiller is expected to urge lawmakers to rewrite rules that make it illegal for drug makers to help Medicare patients pay out-of-pocket costs of their prescription medicines, The Wall Street Journal says. Providing such assistance to Medicare patients and other government programs is considered an illegal kickback, so drug makers limit aid only to patients who have commercial insurance.
Amgen (AMGN) is releasing data on three failed attempts to confirm findings that were published in high-profile scientific journals, which are the sort of details that companies usually keep secret, Nature tells us. The data has been posted online at a newly launched channel called Preclinical Reproducibility and Robustness, which is dedicated to disclosing efforts to confirm scientific findings.
Savant Neglected Diseases is still holding talks with KaloBios Pharmaceuticals, which is in bankruptcy, about completing a deal to sell its drug to treat Chagas disease, The Wall Street Journal reports. Before going bankrupt, KaloBios was run by Martin Shkreli, who planned to seek regulatory approval for the drug and then boost the price more than 100-fold, as we noted here.
The FDA Sentinel database for tracking product safety events is now an “integral part of routine safety surveillance,” the FDA’s Woodcock told a conference Wednesday, Regulatory Focus reports.
Pharma spends big bucks advertising on football, but don’t expect to see any drug ads during the Super Bowl on Sunday, according to STAT.