Convening in San Francisco for the annual conference of the American Diabetes Association this weekend, drugmakers angled for the spotlight in a field made up mostly of similar treatments with small differentiations that could spell the difference between blockbuster sales and also-ran status.
After a manufacturing issue spiked its pitch for FDA approval, a new diabetes drug from Eli Lilly and Boehringer Ingelheim has secured European clearance, lining up to compete in a crowded market.
European regulators are recommending approval for Boehringer Ingelheim and Eli Lilly's latest diabetes offering, shrugging off a manufacturing issue that spiked the drug's FDA approval and putting the pair in line for third place in a new class of treatments.
The FDA has handed AstraZeneca a green light to begin marketing dapagliflozin, its long-delayed SGLT2 diabetes drug, which will now try to defy the steadily dwindling expectations of market analysts. The treatment--the first new FDA drug approval for 2014--will be sold as Farxiga.
AstraZeneca and Bristol-Myers Squibb are heading back to the FDA with the once-spurned dapagliflozin, claiming they've addressed the diabetes drug's cancer risks, but agency staff remains wary of the novel treatment's dangers.
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.
AstraZeneca and Bristol-Myers Squibb are trying once again to get U.S. approval for their drug dapagliflozin, an innovative but potentially risky treatment for Type 2 diabetes.
CHICAGO-- Diabetes partners Boehringer Ingelheim and Eli Lilly's empagliflozin held its own in a slate of Phase III trials, yet the available clinical data make it difficult to show how the experimental treatment stands out from the rest of the SGLT2 bunch.
Jockeying for a leading position in the high-stakes race to develop a new generation of blockbuster diabetes drugs, Merck is hitching a ride with Pfizer's late-stage SGLT2 candidate, ertugliflozin (PF-04971729).