Biogen Idec Inc (BIIB) 308.81 $BIIB
Array BioPharma enters into drug discovery collaboration with Biogen Idec for inflammatory diseases
M2 - 1 hr 24 mins ago
Biopharmaceutical company Array BioPharma (NasdaqGM :ARRY) reported on Wednesday an agreement for the discovery and development of inhibitors targeting a novel kinase for the treatment of autoimmune disorders in collaboration with Biogen Idec (NasdaqGS:BIIB).
Biogen Idec 2014 Annual Shareholder Meeting Webcast
Business Wire - Wed May 28, 3:01PM CDT
Biogen Idec Inc. (NASDAQ: BIIB) announced today that its 2014 Annual Shareholder Meeting will be webcast live on Thursday, June 12, 2014 at 9:00 a.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 An archived version of the webcast will be available following the meeting.
Array BioPharma Announces Drug Discovery Collaboration Agreement With Biogen Idec
PR Newswire - Wed May 28, 8:00AM CDT
Array BioPharma (Nasdaq: ARRY) announced today a collaboration agreement with Biogen Idec (NASDAQ: BIIB) for the discovery and development of inhibitors targeting a novel kinase for the treatment of autoimmune disorders.
Biogen Idec Announces Official Partnership with Sailing Sclerosis' "Oceans of Hope" to Globally Change Perceptions of MS
Business Wire - Wed May 28, 1:00AM CDT
In celebration of World MS Day and as part of its ongoing mission to support those living with Multiple Sclerosis (MS) globally, Biogen Idec (NASDAQ: BIIB) announced that it has joined the Sailing Sclerosis Foundation's (SSF) Oceans of Hope project as principal sponsor and official partner. This multi-year, global campaign is designed to use sailing as a means to educate and empower the MS community, changing perceptions of what it means to live with the disease and demonstrating the benefits of an active lifestyle.
Is Biogen Idec Inc a Buy?
Stephen D., Simpson,, The Motley Fool - Motley Fool - Tue May 27, 5:30PM CDT
This year has turned against biotech investors, as the long-awaited correction came on hard in March and April. While conditions seem to have stabilized for the time being, Biogen Idec remains an outperformer as investors have slower...
Watch for Biogen Idec to Potentially Pullback After Gaining 3.36% Yesterday
Comtex SmarTrend(R) - Tue May 27, 4:05PM CDT
Biogen Idec (NASDAQ:BIIB) traded in a range yesterday that spanned from a low of $299.50 to a high of $310.05. Yesterday, the shares gained 3.4%, which took the trading range above the 3-day high of $303.17 on volume of 1.3 million shares. Often times after large one-day gains, short term traders will seek to take profits and, as such, investors should be cautious.
SmarTrend Watching for Potential Pullback in Shares of Biogen Idec After 3.36% Gain
Comtex SmarTrend(R) - Tue May 27, 4:03PM CDT
Biogen Idec (NASDAQ:BIIB) traded in a range yesterday that spanned from a low of $299.50 to a high of $310.05. Yesterday, the shares gained 3.4%, which took the trading range above the 3-day high of $303.17 on volume of 1.3 million shares. Often times after large one-day gains, short term traders will seek to take profits and, as such, investors should be cautious.
CHMP Still Negative on Teva/Active Biotech's Nerventra - Analyst Blog
Zacks Equity Research - Zacks Investment Research - Tue May 27, 3:45PM CDT
Teva (TEVA) and Active Biotech announced that the CHMP recommended against the approval of Nerventra in the EU.
Nasdaq 100 Plays Catch-Up - Real Time Insight
Kevin Cook - Zacks Investment Research - Tue May 27, 3:23PM CDT
What does the appetite for big-cap growth say about the economy and market?
Biogen's Plegridy Closer to EU Approval - Analyst Blog
Zacks Equity Research - Zacks Investment Research - Tue May 27, 12:10PM CDT
The CHMP issued a positive opinion for Biogen's (BIIB) multiple sclerosis candidate, Plegridy.
MS Awareness Month Brings Good News for Ontarians: Province to Reimburse TECFIDERA(TM), a First-Line Oral Treatment for Multiple Sclerosis
CNW Group - Tue May 27, 5:00AM CDT
Biogen Idec Canada announces today that TECFIDERATM (dimethyl fumarate) is now available for reimbursement in Ontario through the Ontario Public Drugs Program's (OPDP) Exceptional Access Program (EAP), as indicated in the upcoming May 29, 2014, Edition No. 42, Ontario Drug Benefit Formulary/Comparative Index. TECFIDERATM is a first-line oral treatment for adults with relapsing-remitting multiple sclerosis (RRMS). TECFIDERATM is indicated as monotherapy for the treatment of RRMS to reduce the frequency of clinical exacerbations and to delay the progression of disability.(1)
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 -
Array BioPharma enters into drug discovery collaboration with Biogen Idec for inflammatory diseases
M2 - 1 hr 24 mins ago
Biopharmaceutical company Array BioPharma (NasdaqGM :ARRY) reported on Wednesday an agreement for the discovery and development of inhibitors targeting a novel kinase for the treatment of autoimmune disorders in collaboration with Biogen Idec (NasdaqGS:BIIB).
Biogen Idec 2014 Annual Shareholder Meeting Webcast
Business Wire - Wed May 28, 3:01PM CDT
Biogen Idec Inc. (NASDAQ: BIIB) announced today that its 2014 Annual Shareholder Meeting will be webcast live on Thursday, June 12, 2014 at 9:00 a.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 following the meeting.
Array BioPharma Announces Drug Discovery Collaboration Agreement With Biogen Idec
PR Newswire - Wed May 28, 8:00AM CDT
Array BioPharma (Nasdaq: ARRY) announced today a collaboration agreement with Biogen Idec (NASDAQ: BIIB) for the discovery and development of inhibitors targeting a novel kinase for the treatment of autoimmune disorders.
Biogen Idec Announces Official Partnership with Sailing Sclerosis' "Oceans of Hope" to Globally Change Perceptions of MS
Business Wire - Wed May 28, 1:00AM CDT
In celebration of World MS Day and as part of its ongoing mission to support those living with Multiple Sclerosis (MS) globally, Biogen Idec (NASDAQ: BIIB) announced that it has joined the Sailing Sclerosis Foundation's (SSF) Oceans of Hope project as principal sponsor and official partner. This multi-year, global campaign is designed to use sailing as a means to educate and empower the MS community, changing perceptions of what it means to live with the disease and demonstrating the benefits of an active lifestyle.
Is Biogen Idec Inc a Buy?
Stephen D., Simpson,, The Motley Fool - Motley Fool - Tue May 27, 5:30PM CDT
This year has turned against biotech investors, as the long-awaited correction came on hard in March and April. While conditions seem to have stabilized for the time being, Biogen Idec remains an outperformer as investors have slower...
Watch for Biogen Idec to Potentially Pullback After Gaining 3.36% Yesterday
Comtex SmarTrend(R) - Tue May 27, 4:05PM CDT
Biogen Idec (NASDAQ:BIIB) traded in a range yesterday that spanned from a low of $299.50 to a high of $310.05. Yesterday, the shares gained 3.4%, which took the trading range above the 3-day high of $303.17 on volume of 1.3 million shares. Often times after large one-day gains, short term traders will seek to take profits and, as such, investors should be cautious.
SmarTrend Watching for Potential Pullback in Shares of Biogen Idec After 3.36% Gain
Comtex SmarTrend(R) - Tue May 27, 4:03PM CDT
Biogen Idec (NASDAQ:BIIB) traded in a range yesterday that spanned from a low of $299.50 to a high of $310.05. Yesterday, the shares gained 3.4%, which took the trading range above the 3-day high of $303.17 on volume of 1.3 million shares. Often times after large one-day gains, short term traders will seek to take profits and, as such, investors should be cautious.
CHMP Still Negative on Teva/Active Biotech's Nerventra - Analyst Blog
Zacks Equity Research - Zacks Investment Research - Tue May 27, 3:45PM CDT
Teva (TEVA) and Active Biotech announced that the CHMP recommended against the approval of Nerventra in the EU.
Nasdaq 100 Plays Catch-Up - Real Time Insight
Kevin Cook - Zacks Investment Research - Tue May 27, 3:23PM CDT
What does the appetite for big-cap growth say about the economy and market?
Biogen's Plegridy Closer to EU Approval - Analyst Blog
Zacks Equity Research - Zacks Investment Research - Tue May 27, 12:10PM CDT
The CHMP issued a positive opinion for Biogen's (BIIB) multiple sclerosis candidate, Plegridy.
MS Awareness Month Brings Good News for Ontarians: Province to Reimburse TECFIDERA(TM), a First-Line Oral Treatment for Multiple Sclerosis
CNW Group - Tue May 27, 5:00AM CDT
Biogen Idec Canada announces today that TECFIDERATM (dimethyl fumarate) is now available for reimbursement in Ontario through the Ontario Public Drugs Program's (OPDP) Exceptional Access Program (EAP), as indicated in the upcoming May 29, 2014, Edition No. 42, Ontario Drug Benefit Formulary/Comparative Index. TECFIDERATM is a first-line oral treatment for adults with relapsing-remitting multiple sclerosis (RRMS). TECFIDERATM is indicated as monotherapy for the treatment of RRMS to reduce the frequency of clinical exacerbations and to delay the progression of disability.(1)
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 -
