Free Speech 10-2010
This article was originally published in RPM Report
Executive SummaryGovernment and industry officials comment on important regulatory and policy topics.
You may also be interested in...
Despite obvious similarities in the contentious reviews of Sarepta’s Vyondys 53 and its predecessor Exondys 51, drug developers should focus on the differences between the two reviews.
Latest effort by FDA to re-set reviews for novel opioid analgesics is off to a rocky start after three advisory committee reviews. One unintended consequences may already be apparent: by taking a broad, public health perspective on new formulations, the agency may be inviting arguments based on price.
A Washington Post article on price hikes for Abbvie’s Humira highlights patent ‘thickets’ and anti-biosimilar strategies. But the lack of understanding of the basic concepts of the biosimilar system are a much bigger warning sign about the viability of the pathway.