AstraZeneca and Bristol-Myers Squibb today announced they have resubmitted to the U.S. Food and Drug Administration (FDA), a New Drug Application (NDA) for dapagliflozin for the treatment of adults with type 2 diabetes. The NDA resubmission, which is pending acceptance by the FDA, includes several new studies and additional long-term data (up to four years' duration) from previously submitted studies.

Group net sales increased 1% (+3% cc) to USD 14.5 billion in the second quarter, with all divisions contributing to growth in constant currencies. Currency had a negative impact of 2 percentage points mainly from the weakening yen. Excluding the impact of patent expiries, underlying sales grew 8% in constant currencies.

Published in the European Journal of Heart Failure1, results from a new sub-analysis of the RE-LY®* trial demonstrate important benefits of Pradaxa® (dabigatran etexilate) over warfarin in difficult-to-treat patients with non-valvular atrial fibrillation (AF) and previous symptomatic heart failure (HF).

GlaxoSmithKline (GSK) plc has announced submission of supplemental New Drug Applications (NDAs) to the US Food and Drug Administration for use of dabrafenib, a BRAF inhibitor, in combination with trametinib, a MEK inhibitor. Supplemental applications were submitted to each of the currently approved NDAs for the use of each drug in combination with the other, for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 E or K mutation.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that following the results of a regular safety review of the aleglitazar AleCardio phase III trial, the independent Data and Safety Monitoring Board (DSMB) has recommended to halt the trial due to safety signals and lack of efficacy. Based on this recommendation, Roche has decided to terminate the AleCardio trial and all other trials involving aleglitazar.

AstraZeneca today announced that it has entered into an agreement with the University of Cambridge and Cancer Research UK for a two-year collaboration on three pre-clinical and clinical oncology projects. This agreement with world-leading medical research institutions based in Cambridge, UK, aims to advance cancer research through the study of tumour mutations and new investigational therapies in prostate, pancreatic and potentially other cancers.

Novartis today announced that it has entered into a development and licensing agreement with Biological E Limited (BioE), a biopharmaceutical company based in India, for two vaccines to protect against typhoid and paratyphoid fevers. The agreement advances the Novartis goal to deliver accessible and affordable vaccines that address unmet medical need in endemic regions.