Spending User Fees: Biomarker Research, Drug-Device Combos?
This article was originally published in Scrip
Executive Summary
Even though the technical negotiations between the FDA and representatives from the biopharmaceutical industry are just getting underway this month in earnest for the sixth round of the Prescription Drug User Fee Act (PDUFA VI), some regulators and drug makers already have their eyes set on how the money should be spent, or at least, some of it.
You may also be interested in...
Moderna's Valera Takes mRNA Approach To Combat Zika
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's Price Reform Pledge: Will Others Follow?
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.
Clinton's Drug Price Plan: Threat Or Flash In The Political Pan?
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.