Biopharma's long-heralded return to R&D ROI may come up short this year, according to EvaluatePharma, and the next class of approved drugs features fewer blockbusters in waiting than in any of the previous four years.
Lundbeck and its partners at Otsuka are embarking on a lengthy Phase III journey in search of solid evidence that their Alzheimer's drug Lu AE58054 in combination with donepezil can improve the swiftly eroding cognitive functions of Alzheimer's patients.
Regulators at the FDA stamped an approval on Brintellix, a new therapy to treat major depression from Lundbeck and Takeda, just hours before the government prepared to hunker down in a partial shutdown.
The pharma company expects to save about a half billion Danish kroner annually in the move.
Lundbeck and Otsuka are quickly ramping up a 3,000-patient Phase III study for an experimental Alzheimer's drug after claiming success in improving cognition among a group of patients taking the treatment alongside donepezil for 24 weeks in a Phase II trial.
Lundbeck has rolled out a fresh set of positive data on its new antidepressant Brintellix (vortioxetine/Lu AA21004), this time offering up some head-to-head results to help position the drug in the marketplace.
Building on an earlier alliance, Otsuka has gained co-development and co-promotion rights in the U.S., Japan and Europe for Lu AE58054, an experimental Alzheimer's drug now in position for a looming pivotal program.
Denmark's Lundbeck has won European approval for the alcohol dependence drug Selincro (nalmefene), a new approach to fighting addiction which it had in-licensed from Finland's Biotie. But don't expect to see it in the U.S. anytime soon.
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