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News For MRK;PFE;GSK;JNJ;BMY;NVS;SHPG;ABT;CELG;SNY From The Last 14 Days
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January 25, 2016
08:27 EDTBMYBristol-Myers downgraded at BMO Capital
As noted earlier, BMO Capital downgraded Bristol-Myers to Market Perform from Outperform. The firm says that its positive thesis on clinical catalysts for the company's Opdivo drug has "mostly materialized." Target to $70 from $74.
08:04 EDTBMYAgilent's Dako announces FDA expanded approval of Dako PD-L1 IHC 28-8 pharmDx
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07:02 EDTSHPGShire resubmits NDA for lifitegrast to FDA
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06:53 EDTJNJ, GSKGlaxo, Astra, J&J partner with universities in drug research fund, Reuters says
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06:05 EDTBMYBristol-Myers downgraded to Market Perform from Outperform at BMO Capital
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05:36 EDTCELGStocks with implied volatility below IV index mean; CELG INTC
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05:19 EDTMRKAffimed Therapeutics enters into collaboration with Merck
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January 24, 2016
13:50 EDTBMYBristol-Myers says FDA expands indication for Opdivo-Yervoy
Bristol-Myers Squibb announced that the FDA has approved Opdivo, or nivolumab, in combination with Yervoy, or ipilimumab, for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma. "This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials," the company noted. The approval expands the original indication for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma to include patients, regardless of BRAF mutational status, based on data from the Phase 3 CheckMate -067 trial. The FDA also expanded the use of Opdivo as a single-agent to include previously untreated BRAF mutation-positive advanced melanoma patients.
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