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...
WASHINGTON – International will be front and center at this year's BIO International Convention taking place this week in Washington – both in who's coming and in what's being discussed.
WASHINGTON – When it comes to patent reform, the cure may not treat the bite of a growing backlog of patent applications – about 700,000 at last count.
With its sights set on pushing two cancer candidates through the pipeline, GTx Inc. is looking to a $47.5 million public offering to fund Phase III development of Ostarine and Phase II trials for Capesaris.
Regeneron Pharmaceuticals Inc. sold an FDA advisory committee on the benefits of its Eylea as an every-other-month treatment for the neovascular form of age-related macular degeneration (wet AMD).
WASHINGTON – The battle lines have been drawn over how big of an increase the FDA needs in fiscal 2012. House Republicans have said 11 percent should do it, but the president wants a lot more.
