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Bristol-Myers Squibb Company

FDA approves Opdivo for renal cell carcinoma

24 November 2015 | By Victoria White

The announcement marks the approval of the first and only PD-1 inhibitor to deliver significant overall survival in patients with advanced renal cell carcinoma...

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New long-term data for Opdivo in advanced melanoma announced

19 November 2015 | By Victoria White

In the CheckMate -066 trial, Opdivo continued to demonstrate superior overall survival versus dacarbazine with 57.7% of patients alive at two years compared to 26.7% of patients treated with dacarbazine...

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EMA validates type II variation application for Opdivo in RCC

6 November 2015 | By Victoria White

Validation of the application confirms the submission is complete and begins the EMA’s centralised review process...

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Bristol-Myers Squibb to acquire Cardioxyl Pharmaceuticals

3 November 2015 | By Victoria White

The acquisition will give Bristol-Myers Squibb full rights to Cardioxyl’s lead asset CXL-1427...

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FDA approves Yervoy as adjuvant treatment for stage III melanoma

29 October 2015 | By Victoria White

This approval is based on clinical data from a pivotal Phase 3 trial which demonstrated Yervoy significantly improved recurrence-free survival vs. placebo in this setting...

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Bristol-Myers Squibb’s BMS-955176 completes proof-of-concept study

23 October 2015 | By Victoria White

BMS-955176 is a second-generation maturation inhibitor designed to inhibit one of the last steps of the HIV-1 viral lifecycle...

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NICE recommends Daklinza for chronic HCV

16 October 2015 | By Victoria White

NICE has recommended Daklinza for the treatment of patients with chronic hepatitis C virus genotypes 1, 3 and 4...

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Bristol-Myers Squibb to develop Five Prime’s CSF1R antibody programme

15 October 2015 | By Victoria White

As well as an upfront payment of $350 million, Five Prime will be eligible to receive up to $1.05 billion in development and regulatory milestone payments...

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FDA approves Opdivo for metastatic non-squamous NSCLC

12 October 2015 | By Victoria White

In a Phase 3 trial, Opdivo demonstrated superior overall survival (OS) in previously treated metastatic non-squamous NSCLC compared to chemotherapy...

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FDA grants priority review for HCV treatment Daklinza sNDAs

6 October 2015 | By Victoria White

The applications are for the treatment of patients with chronic HCV coinfected with HIV-1, patients with advanced cirrhosis, and for patients with post-liver transplant recurrence of HCV...

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FDA approves Opdivo + Yervoy in melanoma

1 October 2015 | By Victoria White

The announcement marks the first and only FDA approval of a Regimen of two immuno-oncology agents in cancer...

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Breakthrough Therapy Designation for Opdivo in renal cell carcinoma

16 September 2015 | By Victoria White

The designation is based on results of CheckMate -025, a Phase 3 study that evaluated the survival of patients with previously treated advanced or metastatic clear-cell RCC versus everolimus...

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EC approves label update for BMS’ Daklinza

10 September 2015 | By Victoria White

The update allows the use of Daklinza in combination with sofosbuvir for 12 weeks in patients without cirrhosis in all 28 Member States of the European Union...

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First patient enrolled in Phase 4 AUGUSTUS trial of Eliquis

9 September 2015 | By Victoria White

The trial will evaluate the safety of Eliquis versus warfarin or other vitamin K antagonists in patients with nonvalvular atrial fibrillation and a recent acute coronary syndrome or undergoing percutaneous coronary intervention...

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Opdivo demonstrates sustained survival results in squamous NSCLC

8 September 2015 | By Victoria White

In two studies, Opdivo showed an estimated 18 month overall survival rate of 27% to 28% in patients with previously treated squamous non-small cell lung cancer (NSCLC)...

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