Archimedes Pharma Ltd.'s Lazanda isn't the first fentanyl product to get the FDA's nod for breakthrough cancer pain, but its pain-free risk evaluation and mitigation strategy (REMS) and intranasal delivery could give it an edge in the U.S. market once it launches in the fall.
WASHINGTON – Recognizing that regulatory science isn't keeping up with innovation in the U.S., the Biotechnology Industry Organization (BIO) donned its thinking cap to come up with some practical solutions.
WASHINGTON – Compared with the abbreviated new drug process, the biosimilar pathway looks like an intricately choreographed dance of notification, disclosure and negotiations between the innovator and the follow-on.
I confess. When it comes to the BIO International Convention, I’m a newbie. So please forgive me for thinking it was just another conference. I began to see the error of my thoughts as soon as I registered a month or so ago. That’s when I got my first offers for interviews. But even that didn’t prepare me for the flood of meeting requests and invites I’ve received in the past few weeks. And talk about buzz. Practically every phone call began with: “Are you going to BIO?” It was enough to convert even the most passionate Luddite. A tech-curious...