Key Developments: Bristol-Myers Squibb Co (BMY.N)

BMY.N on New York Stock Exchange

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11 Jul 2014
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Latest Key Developments (Source: Significant Developments)

Bristol-Myers Squibb and AbbVie receive U.S. FDA breakthrough therapy designation for elotuzumab, an investigational humanized monoclonal antibody for multiple myeloma
Monday, 19 May 2014 08:00am EDT 

Bristol-Myers Squibb Co and AbbVie Inc:Says U.S. Food and Drug Administration (FDA) grants elotuzumab, an investigational humanized monoclonal antibody, Breakthrough Therapy Designation for use in combination with lenalidomide and dexamethasone for treatment of multiple myeloma in patients.Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions.  Full Article

Bristol-Myers Squibb Co and Celldex Therapeutics Inc's Investigational PD-1 Immune Checkpoint Inhibitor Nivolumab Receives U.S. FDA Breakthrough Therapy Designation for Hodgkin Lymphoma
Wednesday, 14 May 2014 05:00pm EDT 

Bristol-Myers Squibb Co and Celldex Therapeutics Inc:Says U.S. Food and Drug Administration (FDA) granted the investigational PD-1 immune checkpoint inhibitor nivolumab Breakthrough Therapy Designation.for treatment of patients with Hodgkin lymphoma (HL) after failure of autologous stem cell transplant and brentuximab.designation is based on data from cohort of patients with HL in company's ongoing Phase 1b study of relapsed and refractory hematological malignancies.According to FDA, Breakthrough Therapy Designation is intended to expedite development and review of drugs for serious or life-threatening conditions.Criteria for Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.  Full Article

Bristol-Myers Squibb and Celldex Therapeutics announce clinical trial collaboration
Wednesday, 14 May 2014 08:00am EDT 

Bristol-Myers Squibb Co and Celldex Therapeutics Inc:Enters into a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of nivolumab, Bristol-Myers Squibb's investigational PD-1 immune checkpoint inhibitor, and varlilumab, Celldex's CD27 targeting investigational antibody in a Phase 1/2 study.Multiple tumor types will be explored in the study, which could potentially include non-small cell lung cancer (NSCLC), metastatic melanoma, ovarian, colorectal (CRC) and squamous cell head and neck cancers.Bristol-Myers Squibb will make a one-time payment of $5 mln to Celldex and the parties will share development costs.Celldex will be responsible for conducting the Ph 1/2 study, which is expected to begin in the fourth quarter of 2014.  Full Article

Bristol-Myers Squibb Co raises low end of prior FY 2014 non-GAAP EPS to a range in line with analysts' estimates; gives FY 2014 revenue guidance in line with analysts' estimates
Tuesday, 29 Apr 2014 07:30am EDT 

Bristol-Myers Squibb Co:Adjusts FY 2014 GAAP EPS guidance range to $1.70 - $1.80 from $1.75 - $1.90 and its non-GAAP EPS guidance range to $1.70 - $1.80 from $1.65 - $1.80.Expects FY 2014 worldwide revenues between $15.2 bln and $15.8 bln.FY 2014 non-GAAP EPS of $1.78 and revenue of $15.6 bln - Thomson Reuters I/B/E/S.  Full Article

Bristol-Myers Squibb Company acquires iPierian Inc
Tuesday, 29 Apr 2014 07:00am EDT 

Bristol-Myers Squibb Company:Acquires all of iPierian Inc issued and outstanding shares of capital stock and all common stock equivalents in all cash transaction for purchase price of $175 mln.Says with potential for additional development and regulatory milestone payments totaling $550 mln, along with future royalties on net sales.Transaction is expected to be accounted for as asset acquisition for Bristol-Myers Squibb resulting in $175 mln charge during second quarter of 2014.  Full Article

Bristol-Myers Squibb Co and Samsung BioLogics expand manufacturing agreement
Tuesday, 22 Apr 2014 07:00pm EDT 

Bristol-Myers Squibb Co and Samsung BioLogics:Announces increase in scope of their existing manufacturing agreement.Samsung will manufacture commercial drug substances and drug product for several Bristol-Myers Squibb biologic medicines at Incheon manufacturing site.Financial terms of the agreement are not disclosed.  Full Article

Bristol-Myers Squibb Co submits NDA to US FDA for fixed-dose combination tablet of Atazanavir Sulfate with Cobicistat for people living with HIV-1
Monday, 14 Apr 2014 08:00am EDT 

Bristol-Myers Squibb Co:Submission of NDA to US FDA.For fixed-dose combination tablet of Atazanavir Sulfate with Cobicistat for people living with HIV-1.If approved, atazanavir sulfate and cobicistat could offer patients living with HIV-1 a single tablet that eliminates the need to take a boosting agent in a separate tablet.Cobicistat is being developed by Gilead Sciences Inc.  Full Article

Bristol-Myers Squibb Co presents phase III data, Asunaprevir Therapy achieved SVR12 Rates of up to 90 pct
Thursday, 10 Apr 2014 07:00am EDT 

Bristol-Myers Squibb Co:Results of the HALLMARK-Dual study include data among genotype 1b cirrhotic and non-cirrhotic, treatment-na├»ve, non-responder, and peginterferon/ribavirin ineligible and intolerant patients.Phase III results from investigating all-oral, interferon- and ribavirin-free regimen of daclatasvir, a NS5A inhibitor, and asunaprevir , a NS3 inhibitor, among genotype 1b hepatitis C virus infected patients.Results showed that 24-week regimen achieved an overall sustained virologic response 12 weeks after end of treatment.In the study DCV+ASV regimen was generally well tolerated.  Full Article

Bristol-Myers Squibb submits NDAs for Daclatasvir and Asunaprevir to US FDA for the treatment of Hepatitis C
Monday, 7 Apr 2014 08:00am EDT 

Bristol-Myers Squibb Co:Submits new drug applications (NDAs) with the U.S. Food and Drug Administration (FDA) for the investigational products daclatasvir (DCV).Data submitted in the NDAs support the use of DCV+ASV in patients with genotype 1b hepatitis C (HCV).DCV NDA also seeks approval for use of this compound in combination with other agents for multiple genotypes.  Full Article

Oncolys Biopharma cancels exclusive license agreement with Bristol-Myers Squibb
Friday, 4 Apr 2014 02:00am EDT 

Oncolys Biopharma Inc:Canceled the exclusive license agreement signed with Bristol-Myers Squibb on Dec. 14, 2010.License granted by the company for Bristol-Myers Squibb to conduct clinical trial for OBP-601, the phase IIb trial agent for enzyme inhibiting agents.  Full Article

Bristol to seek melanoma approval for Opdivo ahead of expectations

July 10 - Bristol-Myers Squibb Co said on Thursday it plans to seek U.S. marketing approval in the third quarter for its experimental cancer immunotherapy Opdivo as a treatment for advanced melanoma, which would be months sooner than Wall Street expected.

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