An expert panel assembled by the FDA has taken a big step toward blunting the fast-growing market for low-testosterone drugs, raising a thorny issue not just for the companies that sell such remedies, but also for two biotechs trying to gain approvals for new ones.
The 12th annual Fierce 15 report will be rolling out at the BioPharm America meeting in Boston on Monday just before we go live with the report on the website.
Over the last few years we've seen some big changes in the way some drugs are developed. What better time to host a new FierceBiotech executive panel discussion on current trends in late-stage development?
Dow Jones writer Brian Gormley set out to find out the answer to that question, reviewing the venture data for biotech and med tech in Dow Jones' VentureSource database.
First there was AbbVie, the new biopharma company created by the big Abbott split. And now comes Baxalta, the new moniker for Baxter's drug spinoff, which is reportedly plotting a big move to the Boston/Cambridge hub.
GSK vet Jason Gardner is the newly named VP for R&D in the greater Boston area, in charge of a small but growing team of specialists at a brand-new satellite facility that will help coordinate not only the 25-or-so ongoing scientific collaborations with groups like the Harvard Stem Cell Institute but also biotech partnerships with the likes of Epizyme.
Reuters has the "exclusive" this morning that the FDA may approve Merck's PD-1 immuno-oncology superstar pembrolizumab for melanoma some weeks ahead of the October 28 PDUFA date. Then again, they may not, but it's looking good, according to the wire service.
The executive team here at the rapidly expanding headquarters of Novo Nordisk doesn't pull many punches. CEO Lars Rebien Sørensen is a competitive sort who tends to be blunt, aggressive and forward-thinking; projecting a confident attitude that is reflected by the rest of the execs and right down the line to 40,000 rank-and-file employees around the world.
Analysts at Silicon Valley Bank have been crunching the numbers on biotech investing, and they have found that a group of busy corporate venture arms has fundamentally changed the landscape for startups and the entire field of early-state drug development--with some big implications for the current crop of industry upstarts.