The good news for Daiichi Sankyo: Its new anticoagulant drug matched the old standard-issue drug warfarin at preventing stroke and blood clots. And as far as safety goes, edoxaban beat warfarin by a significant stretch. That's an entree into the warfarin-alternative market, expected to grow to $10 billion over the next several years.
The Institute for Safe Medication Practices has flagged its latest set of side-effect reports to the FDA--and once again, anticoagulant drugs are at the top. Boehringer Ingelheim's Pradaxa, a new-generation pill, and the old standard therapy warfarin together accounted for more than 1,100 of the adverse events reported direcctly to the FDA.
German regulators have responded to Der Spiegel 's questions about Xarelto side effects. Answer? The Federal Institute for Drugs and Medical Devices sees no new red flags for patients using the clot-fighting drug developed by Bayer and Johnson & Johnson.
The Basking Ridge, NJ-based biotech had set out to raise around $75 million by selling 5 million shares at $14 to $16 apiece, but had to reconfigure the numbers to 8.4 million shares at $5 a pop when investors failed to line up. At that price Regado would raise $42 million.
Contrary to popular belief, drug R&D spending is not going down. It's also not rising very quickly--but it is headed up.
The U.K.'s cost-effectiveness watchdog gave final clearance to Bayer's anticoagulant drug Xarelto for use in preventing potentially fatal blood clots in the lungs and legs. Meanwhile, Boehringer Ingelheim was filing for European approval for its new-generation anticoagulant, Pradaxa, for similar uses.
With an experimental therapy that could save "millions of lives," biotech startup XO1 Ltd. said it has raised $11 million in a Series A round of financing from Index Ventures.
Index Ventures recently completed an $11 million Series A investment in XO1, an asset-centric company established with the sole objective of developing the monoclonal antibody ichorcumab under license from Cambridge University.
Late last year Regado Biosciences came up with a big $51 million round that served as a kind of down payment on a planned $120 million study of its lead therapy--an anticoagulant that adds a promising "real-time" therapeutic tool to dial the effect up and down in order to control bleeding risks. Not willing to take any offers on the table, though, Regado still had to come up with the rest of the money. And now it's sprung a $75 million IPO designed to take it all the way through Phase III.
What would top Xarelto for Bayer and Johnson & Johnson? Xarelto with an easy antidote.