FDA Panel To Assess Larger Production Scale Of Genzyme’s Myozyme For Pompe’s Disease
This article was originally published in The Pink Sheet Daily
Advisory committee recommendations could carry influence in the follow-on biologics debate.
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FDA tells Genzyme that Myozyme for Pompe's disease made at the firm's 160-liter bioreactor scale is a different product from the same drug made at the 2,000-liter scale, which means approval of the 2,000-liter drug will be delayed - a move that could heighten concerns about the agency's powers regarding biosimilars. Regulators say the carbohydrate structure distinguishes the two Myozymes. Genzyme will put together a new BLA for the 2,000-liter version. The Biotechnology Industry Organization declines comment about FDA leeway and pending biosimilars legislation, saying the questions relate to an individual BIO member's news
The International Fragrance Association North America took a break from its higher-stakes advocacy work Nov. 1 to give lawmakers and congressional staffers a "scent experience." Perfumers from six of the group's biggest members were on hand with "Scents of Home," joined by Monell Center researchers to educate attendees on the mechanics of scent and the important role it plays in people's lives.
NSF International has put its cosmetic product verification program on ice due to lack of interest since its launch in April 2017. Meanwhile, more than 1,000 products from 75+ brands have earned the "EWG Verified" mark, and the NGO says interest is higher than ever following Walmart's announcement in September that it will begin pushing vendors to pursue the verification.