Reaping the benefits of deep-seated R&D reorganization, GlaxoSmithKline had the industry's best 6-year run of FDA nods for new drugs, according to EvaluatePharma, leading its competitors by a wide margin and leaving approval-starved outfits like Eli Lilly and Merck in the dust.
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.
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.
After a high-profile breast cancer failure bit into its potential sales, Eli Lilly's ramucirumab aced a Phase III study in lung cancer, renewing hopes that the star of the drugmaker's oncology pipeline can still deliver on its promise.
Sanofi and its top-selling Lantus may have bought some time last month with a legal wrench in Eli Lilly's spokes, but now Merck has bulldozed its way into the conversation with plans to kick off late-stage studies for its own knockoff of the blockbuster drug, further complicating an already heated fight.
The National Institutes of Health has persuaded 10 rival drugmakers to briefly set aside their competitive spirits and collaborate on drug discovery projects in four major diseases, pooling their data and expertise to kick-start early-stage efforts.
You can scratch Eli Lilly's copycat version of Lantus off its short list of near-term approval prospects. Sanofi says it has filed a lawsuit against Lilly claiming that the pharma rival infringed four of its patents, which is likely to delay any launch until the middle of 2016.
Eli Lilly has won exactly one new drug approval since 2009, running up an innovation debt that is rapidly catching up to its revenue. But CEO John Lechleiter believes the company's late-stage pipeline can change what has become a tired narrative.
Lechleiter recently pointed to animal health as well as key therapeutic areas like neurosciences, diabetes and cancer, according to a report from Reuters.
Eli Lilly has struck a deal with Arteaus Therapeutics to acquire the Cambridge, MA-based company's migraine therapy being studied in a Phase II clinical trial.