The FDA has approved the first drug in a new class of blood glucose-lowering diabetes drugs: Johnson & Johnson's ( $JNJ ) Invokana ( canagliflozin ) for patients with Type II diabetes. The approval gives the healthcare giant its first market green light for a new diabetes therapy.
GlaxoSmithKline has snapped in another piece to its regulatory puzzle, filing its once-weekly Type 2 diabetes treatment albiglutide for an approval in Europe. The treatment is one of a slate of six therapies that the Big Pharma company now has under review on both sides of the Atlantic. And they provide GSK with the chance to argue that its multibillion-dollar R&D effort has begun to pay off.
Cambridge, MA-based Zafgen has taken another big step forward in its quest to develop a unique new weight drug. The biotech has laid out its plans for its first Phase IIa study of beloranib, which inhibits the MetAP2 enzyme.
The biotech says that MABp1 delivered a positive response in a Phase II diabetes study, with patients registering a decline in HbA1c levels that rivals a current blockbuster drug.
Contenders in a race to develop drugs in a new class of blood-sugar lowering meds presented data from key studies today, showing the promise of the SGLT2 inhibitors along with some of the safety issues associated with such treatments.
Pfizer has taken another step toward externalizing research and development. The U.S. drug giant sealed a licensing deal with Russian drug developer SatRx, which has garnered exclusive rights to Pfizer's DPP1-IVi compound for treating Type 2 diabetes.
Lexicon Pharmaceuticals says its SGLT1/SGLT2 inhibitor posted promising results in a Phase IIb study for treatment-resistant Type 2 diabetes.
In the diabetes drug development world, Sanofi's blockbuster basal insulin Lantus offers a tempting competitive target. And yesterday evening Eli Lilly and its partner Boehringer Ingelheim added a few more data points to their case that LY2605541 may be just the program that can topple Lantus from its peak.
Determined to build its stake in the fast-growing diabetes market, Johnson & Johnson plans to showcase late-stage data this weekend on its promising SGLT2 drug candidate that has drawn both praise and skepticism from clinicians and analysts.
Expect a showdown in the diabetes drug market to break out in the coming years as Eli Lilly ($LLY) and Novo Nordisk ($NVO) advance experimental insulin treatments.