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09/12/16 8:58 AM

#331 RE: biopharm #330

$BMY Bristol-Myers Squibb’s PPS @55.66..today announced that the European Commission has approved ORENCIA ® (abatacept) intravenous (IV) infusion and subcutaneous (SC) injection, in combination with methotrexate (MTX), for the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis (RA) not previously treated with MTX. With this approval, ORENCIA is the first biologic therapy with an indication in the European Union (EU) specifically applicable to the treatment of MTX-naive RA patients with highly active and progressive disease. Studies of ORENCIA involving adult patients with high disease activity (mean DAS28-CRP of 5.4) accompanied by poor prognostic factors for rapidly progressive disease (positive for anti-CCP antibodies (also known as ACPA), and/or RF+, presence of baseline joint erosions) provided the clinical trial evidence supporting the recommendation. This approval allows for the expanded marketing of ORENCIA in all 28 Member States of the EU.

Read more

http://news.bms.com/press-release/arthritis/european-commission-approves-bristol-myers-squibbs-orencia-abatacept-treatme


Bristol-Myers Squibb’s

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ATRIPLA® (efavirenz/emtricitabine/tenofovir disoproxil fumarate)
Prescribing Information including Boxed WARNINGS
Patient Information
Product Website
AZACTAM® (aztreonam injection) in GALAXY Plastic Container
Prescribing Information
AZACTAM® (aztreonam for injection, USP)
Prescribing Information
BARACLUDE® (entecavir)
Prescribing Information including Boxed WARNINGS
Patient Information
Product Website
COUMADIN® (warfarin sodium)
Prescribing Information including Boxed WARNING
Medication Guide
Product Website
DAKLINZA™ (daclatasvir)
Prescribing Information
Patient Information
Product Website
DROXIA® (hydroxyurea)
Prescribing Information including Boxed WARNING
ELIQUIS® (apixaban)
Prescribing Information including Boxed WARNING
Medication Guide
Product Website
EMPLICITI™ (elotuzumab)
Prescribing Information
Patient Information
ETOPOPHOS® (etoposide phosphate)
Prescribing Information including Boxed WARNINGS
EVOTAZ™ (atazanavir and cobicistat)
Prescribing Information
Patient Information
Product Website
GLUCOPHAGE® (metformin hydrochloride)
Prescribing Information
GLUCOPHAGE® XR (metformin hydrochloride) EXTENDED RELEASE
Prescribing Information
GLUCOVANCE® (glyburide and metformin hydrochloride)
Prescribing Information
HYDREA® (hydroxyurea)
Prescribing Information
KENALOG®-10 (triamcinolone acetonide)
Prescribing Information
KENALOG®-40 (triamcinolone acetonide)
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LYSODREN® (mitotane)
Prescribing Information including Boxed WARNINGS
MEGACE® (megestrol acetate)
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NULOJIX® (belatacept)
Prescribing Information including Boxed WARNINGS
Medication Guide
REMS Materials
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OPDIVO® (nivolumab)
Prescribing Information
Medication Guide
Product Website
ORENCIA® (abatacept)
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Patient Information
Instructions for Use
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PLAVIX® (clopidogrel bisulfate)
Prescribing Information including Boxed WARNING
Medication Guide
PRAVACHOL® (pravastatin sodium)
Prescribing Information
REYATAZ® (atazanavir)
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Patient Information
Instructions for Use
Product Website
SPRYCEL® (dasatinib)
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Patient Information
Product Website
SUSTIVA® (efavirenz)
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Patient Information
Instructions for Use
SUSTIVA Capsule Instructions for Use Video
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VIDEX® (didanosine)
Prescribing Information including Boxed WARNINGS
Medication Guide
VIDEX® EC (didanosine) DELAYED RELEASE
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Medication Guide
YERVOY® (ipilimumab)
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Medication Guide
Product Website
ZERIT® (stavudine)
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Medication Guide

http://www.bms.com/products/Pages/home.aspx


NEW YORK--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) will host a teleconference on Sunday, October 9, 2016, at 7:30 p.m. CEST (1:30 p.m. EDT) to discuss data presented at the European Society of Medical Oncology (ESMO) 2016 Congress in Copenhagen, Denmark. Company executives will provide an overview of data presented at the meeting, with a focus on the company’s Immuno-Oncology portfolio, and address inquiries from investors and analysts.
http://news.bms.com/press-release/financial-news/bristol-myers-squibb-hold-investor-teleconference-discuss-esmo-2016-con

Link to listen
http://investors.bms.com/investors/news-and-events/events-and-presentations/event-details/2016/ESMO-Investor-Event-2016/default.aspx