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.

FDA has approved more than 100 novel molecules in the past two years, almost all of them without an advisory committee stop. Is it time to revisit a 2007 law that was intended to assure a public vetting of NMEs prior to approval?

US FDA is following through on defining interstitial cystitis and bladder pain syndrome as a single condition – a move that runs counter to the trend towards more targeted, mechanistic definitions of disease. But the agency also offers a unique idea for endpoints that are truly personalized.

Four new pain drug formulations are heading to advisory committees in January. The meetings will also feature new FDA leadership in the pain/addiction review division following the retirement of Sharon Hertz.