Bristol-Myers Squibb and Samsung BioLogics announce biopharmaceutical manufacturing relationship
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- Category: Bristol-Myers Squibb
Bristol-Myers Squibb Company (NYSE:BMY) and Samsung BioLogics today announced the companies have entered into a 10-year agreement under which Samsung BioLogics will manufacture a commercial antibody cancer drug for Bristol-Myers Squibb at its recently completed plant in Songdo Incheon, South Korea.
Pfizer statement on PhRMA-EFPIA principles for responsible clinical trial data sharing
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- Category: Pfizer
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 reports second quarter 2013 financial results
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- Category: Bristol-Myers Squibb
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 resubmit dapagliflozin New Drug Application
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- Category: AstraZeneca
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.
Novartis delivered growth across all divisions in second quarter
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- Category: Novartis
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.
Benefits of Pradaxa® maintained in difficult to treat patients with atrial fibrillation and symptomatic heart failure
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- Category: Boehringer Ingelheim
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).
GSK announces US submission for dabrafenib/trametinib combination in metastatic melanoma
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- Category: GlaxoSmithKline
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.
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