Eli Lilly has won a "tentative" FDA approval for its knockoff of Sanofi's Lantus, but don't look for it at a pharmacy anytime soon. The insulin glargine injection--to be marketed as Basaglar eventually in the U.S.--faces an automatic 30-month stay after Sanofi filed a suit against Lilly and its partner Boehringer Ingelheim claiming patent infringement.
Johnson & Johnson's canagliflozin was the first to win FDA approval among a new class of diabetes therapies, and now it's the star of the first such combination therapy to pass agency muster, helping the drug stand out in an increasingly cluttered market.
After a manufacturing issue scuttled their first attempt, Eli Lilly and Boehringer Ingelheim have won the FDA's blessing to market their new diabetes drug, a late entrant into a crowded space.
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.