US FDA's 1st biosimilar advisory committee meeting: a lovefest
This article was originally published in SRA
Executive Summary
From the outset, the 7 January meeting of the Food and Drug Administration's oncologic drugs advisory committee (ODAC) was a lovefest between regulators and the filgrastim biosimilar from Novartis and its Sandoz unit. Known under the brand name Zarxio, the product won the panel's unanimous support1,2.
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.