BIIB News 299.71 05/27/2014 04:31:44 Biogen Idec Inc (BIIB)

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Global Generic Drugs Market 2014-2018: Actavis, Mylan, Novartis International, STADA Arzneimittel & Teva Pharmaceuticals Dominate the $300+ Billion Industry
M2 - Mon May 26, 3:31AM CDT
Research and Markets (http://www.researchandmarkets.com/research/db5ngc/global_generic) has announced the addition of the "Global Generic Drugs Market 2014-2018: Actavis, Mylan, Novartis International, STADA Arzneimittel & Teva Pharmaceuticals Dominate the $300 Billion Industry" report to their offering. The report states that one of the main challenges in the market is intense competition among vendors, which decreases the profit margins and increases pricing pressure. Mergers and acquisitions has become the core growth strategy among many healthcare vendors; they help vendors grow rapidly and expand their businesses. The Global Generic Drugs market has witnessed a number of mergers and acquisitions among the leading vendors. Vendors have been primarily focusing on mergers and acquisitions to increase their scale, revenue, market share, and competitive advantage. For instance, in November 2012, Actavis acquired Watson Pharmaceuticals and became the third largest generic pharmaceutical company across the globe, with operations in more than 60 countries. In October 2013, Actavis acquired Warner Chilcott plc for approximately US$8.5 billion. Moreover, in 2011, Teva acquired Ratiopharm AG, a leading generic drug manufacturer in Europe, to maintain its position in the market. According to the report, one of the major drivers is the patent expiry of top-selling drugs, which can push the introduction of cheap generic drugs in the market. It is expected that branded drugs with sales of up to US$135 billion will go off-patent by 2015. Key vendors dominating this space include - Actavis plc - Mylan Inc. - Novartis International AG (Sandoz) - STADA Arzneimittel AG - Teva Pharmaceutical Industries Ltd. Other vendors mentioned in the report are - 3SBio Inc. - Amgen Inc. - Apotex Inc. - AstraZeneca plc - Aurobindo Pharma Ltd. - Baxter International Inc. - Berlin-Chemie AG - Biocon Ltd. - Biogen Idec Inc. - Boehringer Ingelheim GmbH - Celltrion Inc. - Cipla Ltd. - Coherus Biosciences Inc. - Daiichi Sankyo Co. Ltd. - Dr. Reddy's Laboratories Ltd. - Emcure Pharmaceuticals Ltd. - Gedeon Richter plc - GlaxoSmithKline plc - Hospira Inc. - Impax Laboratories Inc. - Intas Pharmaceuticals Ltd. - Lupin Ltd. - Merck & Co. Inc. - Mitsubishi Tanabe Pharma Corp. - Par Pharmaceutical Inc. - Pfizer Inc. - Ranbaxy Laboratories Ltd. - Roche Holding AG - Sanofi S.A. - Wockhardt Ltd. For more information visit http://www.researchandmarkets.com/research/db...al_generic

3 Breakthrough Drugs Yield 1 Instant Blockbuster
Todd Campbell, The Motley Fool - Motley Fool - Sat May 24, 10:43AM CDT
The FDA approved 27 new drugs in 2013, including three drugs that were approved under the FDA's breakthrough therapy pathway. That pathway was established by the FDA to speed up clinical trials and FDA approval timelines in a bid to get promising new...

2014 Value Investor 500: The Full List
Dan Dzombak, The Motley Fool - Motley Fool - Sat May 24, 8:01AM CDT
The Value Investor 500 is my attempt to highlight the top 500 publicly traded companies in the U.S. To construct a quality-based list of the top 500 companies in the U.S., I focused on what's really important for investors to pay attention to: ...

Research and Markets: Biogen-Idec's Anti-LINGO-1: 2014 Report
Business Wire - Fri May 23, 6:39PM CDT
Research and Markets (http://www.researchandmarkets.com/research/npfkpd/biogenidecs) has announced the addition of the "Biogen-Idec's Anti-LINGO-1" report to their offering.

Celgene Gains Slightly on Management Changes - Analyst Blog
Zacks Equity Research - Zacks Investment Research - Fri May 23, 3:12PM CDT
Shares of Celgene (CELG) gained slightly following the announcement of a series of organizational changes.

Receptos' RPC1063 for multiple sclerosis
M2 - Fri May 23, 8:32AM CDT
Research and Markets (http://www.researchandmarkets.com/research/r75zqp/receptos_rpc1063) has announced the addition of the "Receptos' RPC1063 for multiple sclerosis" report to their offering. Sphingosine-1 phosphate (S1P) is a bioactive sphingolipid that promotes lymphocyte survival, cell migration, and inflammation. S1P agonism was validated as a therapeutic approach in multiple sclerosis (MS) with the approval of fingolimod (Novartis' Gilenya), a structural analogue of S1P. Fingolimod, an oral non-specific S1P receptor family modulator reduces relapse rates and disability progression in MS, but it has many side effects. The drug has been successful as the first oral disease-modifying drug (DMD) introduced into the MS armamentarium with $1.03 billion in US and $1.9 billion in worldwide sales in 2013. The S1P1 receptor subtype appears to drive fingolimod's clinical benefit (via the inhibition of lymphocyte trafficking), while other receptor subtypes mainly S1P3- account for most of its toxicities. Among safety concerns, cardiac effects, macular edema, and melanoma rates have been particularly concerning. Next generation, selective S1P agonists or modulators are regarded as promising strategies to improve risk/benefit over fingolimod treatment. Receptos is developing RPC1063, pinning its hopes on the hypothesis that a selective S1P1 receptor (S1P1R) agonist, RPC1063, will have activity similar to fingolimod's but with better safety. Other oral, selective S1P modulators in development are: - Siponimod (Novartis) - S1P1 and S1P5 - Ponesimod (Actelion) - S1P1 - ONO-4641 (Merck Serono) - S1P1 and S1P5 - MT-1303 (Mitsubishi Tanabe) - S1P agonist Key Topics Covered: Multiple Sclerosis - Current treatments Sphingosine-1-Phosphate Receptor Modulators - Novartis' fingolimod (Gilenya) - the relevant precedent - Fingolimod's Efficacy in Registration Trials - Safety to Date Receptos' RPC1063: Second Generation S1PR Modulator - Preclinical Studies - Phase I trial in healthy volunteers - QT prolongation study - Phase II/III (RADIANCE trial) Other Selective S1PR Agonists Under Evaluation - Siponimod/BAF312 - (Novartis) - Ponesimod (Actelion) - ONO-4641 (Merck Serono) - MT-1303 (Mitsubishi Tanabe) Clinical and Regulatory Discussion - There is rationale supporting a more specific S1P1 agent - Does S1P5 activity mediate some benefit with fingolimod? - Lymphopenia as a biomarker of activity in MS - Lessons for Receptos - Regulatory Comments - Clinical Trial Design Issues Overview of the Market for MS Therapies Summary Opinion Companies Mentioned: - Actelion - Biogen-Idec - Merck Serono - Mitsubishi Tanabe - Novartis - Receptos - Sanofi - Teva For more information visit http://www.researchandmarkets.com/research/r7...os_rpc1063

Biogen-Idec's Anti-LINGO-1: 2014 Report
M2 - Fri May 23, 8:32AM CDT
Research and Markets (http://www.researchandmarkets.com/research/d3vfr3/biogenidecs) has announced the addition of the "Biogen-Idec's Anti-LINGO-1" report to their offering. LINGO-1 is a CNS-specific protein that is present on axons and oligodendrocytes, the producers of myelin. LINGO-1 acts as an inhibitor of myelination. Biogen-Idec has conducted a robust pre-clinical program that provides compelling proof-of-concept that LINGO-1 blockade promotes remyelination. BIIB033, Biogen-Idec's anti-LINGO-1 antibody, has generated significant interest as it represents a novel approach to treat multiple sclerosis. Currently, phase II exploratory studies in patients with relapsing forms of MS and in acute optic neuritis often associated with MS are underway. The main goal of current drugs for MS is to reduce the autoimmune reaction against CNS components, mainly myelin. These drugs act to suppress lymphocyte subsets, reduce trafficking of immune cells across the blood-brain-barrier, and/or to cause autoreactive cells to be retained in peripheral lymphoid organs. Other potential remyelination therapies in development are: - GSK239512 (Glaxo SmithKline) - an oral, histamine 3 receptor antagonist - rHIgM22 (Acorda Therapeutics) - a naturally occurring antibody that promotes myelin repair - VX15/2503 (Vaccinex) - an anti- Semaphorin 4D Key Topics Covered: Multiple Sclerosis - The Pathobiology of MS - Current treatments for RRMS - Remyelination as a Therapeutic Approach in MS - LINGO-1 blockade in animals promotes remyelination Biogen-Idec's BIIB033 - Preclinical Experiments - Clinical trials - Ongoing Phase II Trials Clinical And Regulatory Discussion - How relevant are animal models to human MS disease? - How can clinical benefit of BIIB033 in MS be demonstrated? - Are BIIB033 levels in the CNS after systemic administration sufficient to produce remyelination in humans? - What are relevant and acceptable clinical endpoints? - Imaging techniques to assess remyelination still need to be validated - What biomarkers may be useful to suggest remyelination benefit? - What possible scenarios could play out for clinical development of BIIB033? - Competitive Landscape Overview of the Market for MS Therapies - US Market for MS Therapies - What price can BIIB033 command? - Who will be candidates for BIIB033? - LINGO-1 could be a therapeutic target in other conditions besides MS Summary Opinion Companies Mentioned: - Accorda - Biogen-Idec - Glaxo SmithKline - Novartis - Vaccinex For more information visit http://www.researchandmarkets.com/research/d3...iogenidecs

CHMP Adopts Positive Opinion for PLEGRIDY(TM) (Peginterferon Beta-1a) as a Treatment for Multiple Sclerosis in the European Union
Business Wire - Fri May 23, 6:59AM CDT
--- PLEGRIDY May Offer People with MS a Combination of Efficacy, Favorable Safety Profile and Low Frequency Dosing Schedule -

Secondary Offering, Appointments, and Clinical Developments - Analyst Notes on HCA, Biogen Idec, WellPoint, AbbVie and Mylan
PR Newswire - Fri May 23, 6:00AM CDT
Today, Analysts Review released its analysts' notes regarding HCA Holdings Inc (NYSE: HCA), Biogen Idec Inc (NASDAQ: BIIB), WellPoint Inc (NYSE: WLP), AbbVie Inc (NYSE: ABBV) and Mylan Inc (NASDAQ: MYL). Private wealth members receive these notes ahead of publication. To reserve complementary membership, limited openings are available at: http://www.analystsreview.com/2836-100free.

Senior Level Appointments, Collaboration Agreements, Prestigious Awards Nominations, and Company Updates - Analyst Notes on Biogen Idec, Questcor, Zimmer, Cigna and Ctrip.com
PR Newswire - Thu May 22, 7:40AM CDT
Today, Analysts Review released its analysts' notes regarding Biogen Idec Inc. (NASDAQ: BIIB), Questcor Pharmaceuticals, Inc. (NASDAQ: QCOR), Zimmer Holdings, Inc. (NYSE: ZMH), Cigna Corporation (NYSE: CI) and Ctrip.com International Ltd. (NASDAQ: CTRP). Private wealth members receive these notes ahead of publication. To reserve complementary membership, limited openings are available at: http://www.analystsreview.com/2808-100free.

RBCC and n3D Take World's First Commercially Available 3D Bioprinting System Global
Business Wire - Thu May 22, 4:00AM CDT
As they continue to spread the word about the revolutionary BiO Assay, joint venture partners Rainbow Coral Corp. (OTCBB: RBCC) and Nano3D Biosciences (n3D) are taking the 3D bioprinting technology international this spring and summer.

Watch for Biogen Idec to Potentially Pullback After Gaining 1.92% Yesterday
Comtex SmarTrend(R) - Wed May 21, 4:18PM CDT
Biogen Idec (NASDAQ:BIIB) traded in a range yesterday that spanned from a low of $290.12 to a high of $296.76. Yesterday, the shares gained 1.9%, which took the trading range above the 3-day high of $293.81 on volume of 971,000 shares. Often times after large one-day gains, short term traders will seek to take profits and, as such, investors should be cautious.

Biogen Idec Set to Possibly Pullback After Yesterday's Rally of 1.92%
Comtex SmarTrend(R) - Wed May 21, 4:18PM CDT
Biogen Idec (NASDAQ:BIIB) traded in a range yesterday that spanned from a low of $290.12 to a high of $296.76. Yesterday, the shares gained 1.9%, which took the trading range above the 3-day high of $293.81 on volume of 971,000 shares. Often times after large one-day gains, short term traders will seek to take profits and, as such, investors should be cautious.

Biogen Idec to Present at the Sanford Bernstein 30th Annual Strategic Decisions Conference
Business Wire - Wed May 21, 3:01PM CDT
Biogen Idec Inc. (NASDAQ: BIIB) announced today that it will present at the Sanford Bernstein 30th Annual Strategic Decisions Conference. The webcast will be live on Wednesday, May 28, 2014 at 2:00 p.m. ET. To access the live webcast, please visit Biogen Idec's Investors section at www.biogenidec.com. An archived version of the webcast will be available for 14 days following the presentation.

Insider Trading Alert - IMPV, BIIB And SNDK Traded By Insiders
at The Street - Wed May 21, 10:00AM CDT
Stocks with insider trader activity include IMPV, BIIB and SNDK

Biotech Tweet of the Week: Share Buybacks
Brian Orelli, The Motley Fool - Motley Fool - Tue May 20, 5:30PM CDT
We've got a pair of related tweets on this week's episode of Biotech Banter . The first is from Jason Napodano, an analyst at Zacks, who asks, "Does anyone actually finish a share buyback in biotech, or do they just announced another one after they...

Global B-Cell Chronic Lymphocytic Leukemia Therapeutics Pipeline Review H1 2014 - 13 Companies & 23 Drug Profiles
M2 - Tue May 20, 10:05AM CDT
Research and Markets (http://www.researchandmarkets.com/research/sztpvs/bcell_chronic) has announced the addition of the "B-Cell Chronic Lymphocytic Leukemia - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for B-Cell Chronic Lymphocytic Leukemia, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for B-Cell Chronic Lymphocytic Leukemia and special features on late-stage and discontinued projects. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Reasons to buy - Provides strategically significant competitor information, analysis, and insights to formulate effective R&D development strategies - Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage - Develop strategic initiatives by understanding the focus areas of leading companies - Identify and understand important and diverse types of therapeutics under development for B-Cell Chronic Lymphocytic Leukemia - Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline - Devise corrective measures for pipeline projects by understanding B-Cell Chronic Lymphocytic Leukemia pipeline depth and focus of Indication therapeutics - Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope - Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline Companies Involved in Therapeutics Development - Biogen Idec Inc. - rEVO Biologics - Nippon Shinyaku Co., Ltd. - Ono Pharmaceutical Co., Ltd. - Immunomedics, Inc. - MABLife S.A.S - SBI Biotech Co., Ltd. - Neopharm Ltd. - Advancell - Vivia Biotech, S.L. - AbbVie Inc. - BioNovion B.V. - TheraMAB LLC. Drug Profiles - acadesine - bafetinib - rituximab - Allogeneic CD19CAR-TCM cells - FBTA-05 - CD19.CAR-CD28Z T Cells - CD19 Specific T Cell - GNKG-168 - ilorasertib - ONO-4059 - Allogeneic Cell Therapy Tumor-Derived Lymphocytes - Gene Modified T Cells for Leukemia - TG-20 - MAT-304 - Vivia-009 - Monoclonal Antibody Targeting APRIL - alemtuzumab biosimilar - GNKS-356 - TAB-08 - Central Memory T Cell Therapy For Cancer - 202-b - Xanthone Derivatives For Cancer - alemtuzumab biosimilar For more information visit http://www.researchandmarkets.com/research/sz...ll_chronic

Is InterMune Inc. Your Next Biotech Buyout?
David Williamson and Michael Douglass, The Motley Fool - Motley Fool - Mon May 19, 8:45PM CDT
InterMune  was health care's top performing stock, thanks to positive phase 3 trial results for its lead drug Esbriet in idiopathic pulmonary fibrosis. Shares popped nearly 15% as Esbriet compared favorably with a competing drug also in late-stage...

Academic and Pharmaceutical Leaders Meet at the ALS Therapy Development Institute to Discuss Biomarkers in ALS
PRWeb - Mon May 19, 8:13AM CDT
The ALS Therapy Development Institute (ALS TDI) announced today that it is hosting a meeting on-site with leaders in academia and Pharma to discuss biomarkers in ALS. The meeting, held in collaboration with The ALS Association (ALSA), brings together 24 leaders from various academic institutions and pharmaceutical companies, including Genentech, Pfizer, Astra Zeneca, Biogen Idec, Bristol-Myers Squibb, Iron Horse Diagnostics, Inc., University of Massachusetts Medical School, Massachusetts General Hospital, SUNY Upstate Medical University, Barrow Neurological Institute, Voyager Therapeutics, The Michael J. Fox Foundation for Parkinson's Research, Weiner Laboratory, Northeast ALS Consortium, National Institute of Neurological Disorders and Stroke (NINDS), ALSA and ALS TDI.

Semi-Annual Changes to the NASDAQ OMX CRD Global Sustainability Index
GlobeNewswire - Mon May 19, 7:05AM CDT
The NASDAQ OMX Group, Inc. (Nasdaq:NDAQ), and CRD Analytics today announced the results of the semi-annual re-ranking of the NASDAQ OMX CRD Global Sustainability Index (Nasdaq:QCRD), which will become effective prior to market open on Monday, May 19, 2014.
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