Theorem Clinical Research

Biogen Idec

FDA approves Biogen Idec’s Plegridy for multiple sclerosis

Monday, August 18, 2014 09:13 AM

The FDA has approved Biogen Idec’s Plegridy (peginterferon beta-1a), a new treatment for people with relapsing forms of multiple sclerosis (RMS). Plegridy, the only pegylated beta interferon approved for use in RMS, is dosed once every two weeks and can be administered subcutaneously with the Plegridy Pen, a new, ready-to-use autoinjector, or a prefilled syringe.

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Regulus Therapeutics, Biogen Idec collaborate for multiple sclerosis biomarkers

Wednesday, August 6, 2014 12:58 PM

Regulus Therapeutics, a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs, has entered into a new collaboration agreement with Biogen Idec to expand its research focused on identifying microRNAs as biomarkers for multiple sclerosis (MS) under its Regulus microMarkers division. The new research will focus on profiling a large number of whole blood samples from a cohort of MS patients who have been treated with a Biogen Idec MS therapy to identify potential microRNA signatures. 

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FDA approves antihemophilic factor, Fc fusion protein hemophilia A

Thursday, June 12, 2014 11:33 AM

The FDA has approved Eloctate, Antihemophilic Factor (Recombinant), Fc fusion protein, for use in adults and children who have hemophilia A. Eloctate is the first hemophilia A treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding.

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Pulmonary Fibrosis Foundation, Biogen Idec partner on PFF Patient Registry

Wednesday, June 11, 2014 12:44 PM

The Pulmonary Fibrosis Foundation (PFF) has partnered with Biogen Idec to support the PFF Patient Registry.

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DrugDev acquires TrialNetworks

Monday, May 5, 2014 10:13 AM

DrugDev, a global network of active clinical trial doctors, has acquired Newton, Mass.-based TrialNetworks. TrialNetworks joins an expanding group of technology-driven solutions to help sponsors, CROs and sites do more trials together.

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Quintiles, Biogen Idec ink 5-year partnership

Thursday, April 24, 2014 01:04 PM

CRO Quintiles and Biogen Idec have entered into a five-year strategic clinical development agreement. The collaboration is designed to leverage the expertise and experience from both organizations to optimize Biogen Idec’s clinical development processes.

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Ian Read becomes PhRMA board chairman; Ken Frazier, George Scangos on board

Friday, April 18, 2014 10:37 AM

Ian C. Read, chairman and CEO of Pfizer, was elected chairman of the Pharmaceutical Research and Manufacturers of America (PhRMA). Read succeeds Robert J. Hugin, chairman and CEO of Celgene, as PhRMA's chairman. Also elected were Kenneth C. Frazier, chairman, president and CEO of Merck, as chairman-elect of the PhRMA board of directors, and George A. Scangos, Ph.D., CEO of Biogen Idec, as board treasurer.

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Icon’s Firecrest training recognized by TransCelerate BioPharma

Monday, April 14, 2014 10:13 AM

Icon,a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, has announced that its Firecrest training meets TransCelerate BioPharma’s minimum criteria for International Conference on Harmonization Good Clinical Practice (ICH/GCP) training.

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TrialNetworks wins Disruptive Technology and Innovator of the Year Award

Friday, April 11, 2014 11:37 AM

TrialNetworks and its Clinical Trial Optimization System won the Disruptive Innovator and Technology of the Year award from Partnerships in Clinical Trials 2014. The award honors an individual or a company with a new disruptive technology platform that has increased the efficiency and quality of clinical trials. TrialNetworks technology is used by companies including Merck, Biogen Idec, Ariad Pharmaceuticals and Infinity Pharmaceuticals to optimize clinical operations from startup through closeout.

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FDA approves long-acting recombinant coagulation Factor IX concentrate for hemophilia B

Monday, March 31, 2014 01:10 PM

The FDA has approved Alprolix, Coagulation Factor IX (Recombinant), Fc Fusion Protein, for use in adults and children who have Hemophilia B. Alprolix is the first Hemophilia B treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding.

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CWWeekly

September 15

WIRB-Copernicus Group acquires New England IRB

BBK Worldwide secures $3 million in private ἀnancingto accelerate its global and technological expansion

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The CenterWatch Monthly

August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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The CenterWatch Monthly

July

IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

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