FDA panel says Lilly imaging agent not yet ready for market
This article was originally published in Scrip
A US FDA advisory panel 20 January said Lilly's non-therapeutic radiopharmaceutical Amyvid (florbetapir F 18) is not ready for use with positron emission tomography (PET) to rule out the presence of beta-amyloid in the brain, but left open the possibility of an approval if certain criteria are met.
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.