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News Breaks
April 7, 2014
08:06 EDTBMYBristol-Myers submits NDAs for Daclatasvir and Asunaprevir to FDA
Bristol-Myers Squibb Company has submitted new drug applications with the U.S. Food and Drug Administration for the investigational products daclatasvir, an NS5A replication complex inhibitor, and asunaprevir, a NS3 protease inhibitor. The data submitted in the NDAs support the use of DCV+ASV in patients with genotype 1b hepatitis C. The DCV NDA also seeks approval for use of this compound in combination with other agents for multiple genotypes. The submissions are subject to FDA review for acceptance for filing. These submissions follow the recent announcement that the FDA granted the investigational DCV Dual Regimen Breakthrough Therapy Designation. In 2013, the investigational all-oral 3DAA Regimen also received Breakthrough Therapy Designation, and the company anticipates submitting this regimen for FDA review in Q1 2015.
News For BMY From The Last 14 Days
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June 26, 2015
08:31 EDTBMYAlexandria Real Estate announces lease with Bristol-Myers in Cambridge
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June 25, 2015
09:34 EDTBMYBristol-Myers expects Waltham site to close in early 2018
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09:32 EDTBMYBristol-Myers opens research site in Cambridge, discontinues virology research
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June 24, 2015
07:29 EDTBMYFDAnews to hold a summit
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June 22, 2015
08:52 EDTBMYPortola, Bristol-Myers, and Pfizer announce results from Phase 3 ANNEXA study
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05:35 EDTBMYAllied-Bristol Life Sciences licenses IP from Harvard University
Allied-Bristol Life Sciences, a biopharmaceutical enterprise jointly owned by Allied Minds and Bristol-Myers Squibb, announced that it has entered into a licensing agreement with Harvard University based on research and intellectual property developed in Professor Malcolm Whitmanís lab at the Harvard School of Dental Medicine. Building on previous studies conducted with Mark Sundrud, PhD, and Anjana Rao, PhD, at Boston Childrenís Hospital, Professor Whitmanís lab, in collaboration with Professor Ralph Mazitschek, PhD, at the Center for Systems Biology at Massachusetts General Hospital, has shown that HF works through inhibition of Prolyl-tRNA synthetase, which leads to activation of an amino acid restriction response pathway. Based on this novel and differentiated mechanism, several lead molecules have been identified by the groups at HMS and MGH that have the potential to lead to effective therapy for several conditions including fibrotic and autoimmune diseases. The licensing agreement with Harvardís Office of Technology Development is among the first in a series of discovery and development projects that Allied-Bristol Life Sciences intends to pursue. The license to the technology from Professor Whitmanís lab will be held by a new ABLS subsidiary specifically formed to pursue further research and pre-clinical development of the technology and associated molecules.
June 19, 2015
11:39 EDTBMYBristol-Myers announces European Commission approval of Opdivo
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June 17, 2015
10:00 EDTBMYOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: AbbVie (ABBV) initiated with an Overweight at Piper Jaffray... Arista Networks (ANET) initiated with a Buy at Sterne Agee CRT... Astec (ASTE) initiated with a Buy at Maxim... Bristol-Myers (BMY) initiated with an Underweight at Piper Jaffray... Community Healthcare (CHCT) initiated with an Outperform at Oppenheimer... Eli Lilly (LLY) initiated with an Overweight at Piper Jaffray... Fitbit (FIT) initiated with a Buy ahead of IPO at Dougherty... Hortonworks (HDP) initiated with a Buy at Mizuho... II-VI (IIVI) initiated with a Buy at Benchmark Co.... J Sainsbury (JSAIY) initiated with an Underperform at Credit Suisse... McDermott (MDR) initiated with an Outperform at Cowen... Merck (MRK) initiated with a Neutral at Piper Jaffray... Molina Healthcare (MOH) initiated with a Buy at UBS... Pacific DataVision (PDVW) initiated with a Buy at Canaccord... Pfizer (PFE) initiated with an Overweight at Piper Jaffray... Quest Resource (QRHC) initiated with a Buy at Roth Capital... Regional Management (RM) initiated with a Buy at Janney Capital... Rofin-Sinar (RSTI) initiated with a Buy at Benchmark Co.... Salesforce (CRM) initiated with a Neutral at Exane BNP Paribas... Sprouts Farmers Markets (SFM) initiated with a Neutral at Cleveland Research... Tesco (TSCDY) initiated with an Underperform at Credit Suisse... WM Morrison (MRWSY) initiated with a Neutral at Credit Suisse... WWE (WWE) initiated with a Buy at BTIG... World Acceptance (WRLD) initiated with a Buy at Janney Capital... Zafgen (ZFGN) initiated with a Buy at SunTrust.
07:25 EDTBMYPiper calls Bristol 'modestly overvalued,' starts shares with sell
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05:31 EDTBMYBristol-Myers initiated with an Underweight at Piper Jaffray
Target $60.

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