The FDA has rejected one of Eli Lilly's top drug prospects partnered with Boehringer Ingelheim, saying that its SGLT2 drug empagliflozin could not be approved for marketing before Boehringer fixed "deficiencies" at one of its manufacturing facilities.
A couple of day ago, Israel's Andromeda Biotech bought back the worldwide rights to its Phase III diabetes therapy--DiaPep277 for Type 1 patients--from Teva for $72 million, to be paid on an installment plan based on future revenue. And today, Andromeda's parent company Clal says it's in talks with a U.S. pharma company to sell Andromeda and DiaPep277.
Eli Lilly says its closely-watched GLP-1 diabetes drug dulaglutide works as well as the market leading therapy Victoza, but isn't superior to the rival drug. That's going to be good enough for Lilly to claim a big win, though, as analysts were ready to hand it a victory on non-inferiority for a drug now in the hands of regulators.
A busy Servier wants to explore Celladon's technology to see if there are some small molecule applications to diabetes and other metabolic conditions that warrant clinical development.
Takeda has suffered a major setback in its quest to fill the blockbuster gap left by last year's loss of patent protection for the diabetes drug Actos. The pharma company reported that it was forced to scrap its late-stage program for the pioneering GPR40 agonist TAK-875, or fasiglifam, after trial monitors picked up clear signs of liver toxicity in patients.
Sanofi has peeled back the cover on another chapter of Phase III data for U300, advancing its case that its next-gen diabetes therapy can be safer and just as effective as its blockbuster Lantus as it sets the stage for a regulatory pitch next year. But analysts may be left wondering if the long-acting insulin can successfully beat back rivals with a better set of data.
GLP-1 drugs have long been one of the hottest targets in diabetes R&D, attracting the attention of the all of the giants that play in this blockbuster market. But now Roche has its eye on an early-stage program that could do GLP-1 drugs one better.
Some analysts wanted to know what Lilly's Plan B is, given the fresh wave of generic competition that's about to hit its biggest franchise. What happens if Lilly's current crop of late-stage drugs--frequently touted at the top as one of the biggest and best in the industry--fails to deliver soon?
Novo Nordisk experienced a nasty setback early this year when the FDA rejected its long-acting insulin Tresiba. But with the diabetes treatment rolling out in other markets, Novo is prepared to confidently bet upwards of $3.7 billion doing the groundwork necessary to develop new oral diabetes therapies and next-gen approaches as it defends its growing franchise for Victoza.
Two years after AstraZeneca and Bristol-Myers Squibb ran into a buzzsaw of regulatory criticism at the FDA for their SGLT2 diabetes drug dapagliflozin, the partners are back with a fresh set of promising Phase III data they hope can help provide the key needed to unlock the U.S. market.