Lobbying group BIO released a new video (pictured above) to try and explain drug costs.
1. The Biotechnology Innovation Organization, a lobbyist for drugmakers, released a video explaining the prescription drug supply chain to consumers to help them understand their drug costs. The video specifically breaks down the difference between list and net price of drugs and how pharmacy benefit managers and insurers operate in the healthcare system. (Video)
2. FDA officials committed to a 10-month review process for approving generic drugs and an accelerated 8-month timeline for completing applications for therapies expected to have a significant impact on public health. The changes are expected to be a part of the agency’s upcoming reauthorization of the Prescription Drug User Fee Act. (Roll Call)
3. The FDA released new draft guidance to inform drugmakers about how to design late-stage trials for treatments that seek to raise women’s libido. The guidance follows the FDA approval of Valeant Pharmaceuticals International’s pill for low-sexual desire, Addyi. That approval was criticized for its trial design. (Bloomberg)
4. Mylan’s EpiPen could soon face competition from Kaléo. The drugmaker previously licensed its emergency anaphylaxis treatment, Auvi-Q, to Sanofi, but it reclaimed the rights last February after Sanofi withdrew the product from the market. (NYT)
5. Harvard University researchers said they built the first 3D-printed heart-on-a-chip, which can collect data such as heart rate for scientific studies. The new approach could help advance the development of other organs-on-chips that match specific disease properties unique to a patient. (Gizmodo)