FDA replaces rather than rescinds Merck's breakthrough status
This article was originally published in Scrip
The FDA reversed course on its intention to rescind the breakthrough therapy status it had awarded in October 2013 to Merck for its investigational combination hepatitis C virus (HCV) drug grazoprevir/elbasvir (MK-5172/MK-8742), and now the company holds not one, but two of the coveted designations for the experimental medicine.
You may also be interested in...
With new funding in hand, Moderna and its infectious disease venture Valera are going full-speed ahead with a Zika vaccine, taking an mRNA approach, which they said could be a more rapid strategy to try to stop the disease.
Allergan CEO Brent Saunders vows not to engage in price gouging and says his firm will limit cost increases to single-digit percentages, occurring only once per year. But it's unclear whether Saunders will stand as a lone wolf in the industry or if others will make similar pledges.
Hillary Clinton's plan to rein in high prices of older medicines, which includes creating a federal panel that has authority to impose fines, may grab headlines, but some analysts think it's unlikely to get very far in a divided Washington.