Two years after a stinging rejection at the hands of the same committee, Bristol-Myers Squibb and AstraZeneca got a warmer reception for their diabetes drug dapagliflozin, winning a recommendation from an FDA advisory panel and brightening their odds of approval for the once-rebuffed therapy.
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.
GW Pharmaceuticals has expanded mindsets about potential diabetes treatment. In a small midstage study of patients on its pot-based drug candidate, the U.K. drug developer showed improvements in insulin production and other benefits.
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.