The Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) have published new commitments for responsible data sharing practices by biopharmaceutical companies. The new commitments are designed to expand access to clinical trial data and advance science.

Bristol-Myers Squibb Company (NYSE: BMY) today reported results for the second quarter of 2013 highlighted by the resubmission of Forxiga in the U.S., the completion of regulatory filings for Eliquis and Metreleptin in the U.S., and the presentation of important data from its immuno-oncology franchise at ASCO, for Orencia® at EULAR and for Eliquis at ISTH.

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.