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News Breaks
July 7, 2014
07:01 EDTBMYBristol-Myers says Daklinza approved by Japan's MHLW
Bristol-Myers Squibb Company announced that the Japanese Ministry of Health, Labor and Welfare has approved Daklinza, a potent, pan-genotypic NS5A replication complex inhibitor, and Sunvepra, a NS3/4A protease inhibitor, providing a new treatment that can lead to cure for many patients in Japan who currently have no treatment options. The Daklinza+Sunvepra Dual Regimen is Japan’s first all-oral, interferon- and ribavirin-free treatment regimen for patients with genotype 1 chronic hepatitis C virus infection, including those with compensated cirrhosis. The indications for Daklinza and Sunvepra in Japan are for the improvement of viraemia in either of the following patients with chronic hepatitis C genotype 1, or chronic hepatitis C genotype 1 with compensated cirrhosis: (1) patients who are ineligible or intolerant to interferon-based therapy, and (2) patients who have failed to respond to interferon-based therapy. The approval is supported by results from a Phase III study demonstrating that the 24-week regimen of Daklinza and Sunvepra achieved overall SVR24 among 84.7% of Japanese HCV patients with genotype 1b. Among patients 65 years of age or older who were either interferon-ineligible or intolerant, 91.9% achieved SVR24. Further, patients with compensated cirrhosis present at baseline had overall SVR24 rates of 90.9%.
News For BMY From The Last 14 Days
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April 17, 2015
09:41 EDTBMYBristol-Myers up after Phase III Opdivo study met endpoint, trial stopped early
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09:36 EDTBMYActive equity options trading on open
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09:08 EDTBMYBristol-Myers data should be positive, says SunTrust
SunTrust expects the AACR data for Bristol-Myers' CheckMate-069 Opdivo + Yervoy combo, a treatment for melanoma, to show a positive overall response rate and progressive free survival that exceeds its prior -0004 results. The firm notes that the data is due to be presented on April 20. It raised its 2020 Opdivo revenue estimate to $7.1B versus the Street's $6.9B and raised its price target o n he stock to $74 from $70 while keeping a Buy rating on the shares.
08:58 EDTBMYBristol-Myers jumps 4% after Opdivo study stopped early after meeting endpoint
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08:56 EDTBMYBristol-Myers says Phase III Opdivo study met endpoint, trial stopped early
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April 16, 2015
12:16 EDTBMYEli Lilly and Bristol-Myers restructure Erbitux collaboration in N. America
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08:59 EDTBMYGene therapy companies could benefit from increased attention, says Roth Capital
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April 15, 2015
09:08 EDTBMYOn The Fly: Pre-market Movers
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07:41 EDTBMYEBD Group to hold a forum
ChinaBio Partnering Forum 2015 is being held in Shanghai, China on April 15-16.
07:03 EDTBMYLexicon and Bristol-Myers select development candidate for neuropathic pain
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April 8, 2015
08:08 EDTBMYuniQure price target raised to $50 from $28 at Leerink
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08:06 EDTBMYBristol-Myers completes acquisition of Flexus Biosciences
Bristol-Myers Squibb Company announced that it has completed the previously announced planned acquisition of Flexus Biosciences, Inc. The transaction includes full rights to F001287, Flexus’ lead preclinical, small-molecule IDO1-inhibitor targeted for IND filing in the second half of 2015 and an IDO/TDO discovery program that includes its IDO-selective, IDO/TDO dual and TDO-selective compound libraries. A newly formed entity established by the current shareholders of Flexus will retain, from and after the closing, all non-IDO/TDO assets of Flexus including those related to Flexus’ Phase 1 FLT3 and CDK4/6 inhibitor, its earlier stage small-molecule Treg cancer immunotherapy programs, and its current personnel and facilities.
April 7, 2015
07:14 EDTBMYEyeforpharma to hold a summit
Philadelphia 2015 Commercial Pharma Summit is being held in Philadelphia on April 7-8.
April 6, 2015
16:17 EDTBMYOn The Fly: Closing Wrap
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12:44 EDTBMYOn The Fly: Midday Wrap
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12:13 EDTBMYuniQure price target raised to $40 from $35 at Piper Jaffray
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08:13 EDTBMYCelldex announces initiation of Phase 1/2 study of Varlilumab combination
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07:33 EDTBMYBristol-Myers announces strategic collaboration with uniQure
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