Theorem Clinical Research

Genzyme

FDA expands approval of Lumizyme to treat Pompe disease

Monday, August 4, 2014 03:27 PM

The FDA has approved Lumizyme (alglucosidase alfa) for treatment of patients with infantile-onset Pompe disease, including patients who are less than eight years of age. In addition, the risk evaluation and mitigation strategy (REMS) known as the Lumizyme ACE (Alglucosidase Alfa Control and Education) Program is being eliminated.

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Jon L. Hart named CEO of med fusion

Friday, April 11, 2014 01:23 PM

med fusion, an integrated, advanced laboratory and clinical trials service organization, has appointed Jon L. Hart CEO, effective March 31. This appointment is the next step in the organization’s continued drive towards becoming the clear leader in providing lab and clinical trial support to healthcare providers and biotech/pharmaceutical companies through a patient-centric support model.

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Minerva Neurosciences expands executive team

Thursday, March 6, 2014 10:30 AM

Minerva Neurosciences, a developer of new therapies to treat neuropsychiatric diseases and disorders, has launched the new company web site (www.minervaneurosciences.com) following the successful transfer of the Minerva Neurosciences corporate headquarters from New Jersey to Cambridge, Mass. The establishment of a new corporate headquarters follows the recent appointment of Rogerio Vivaldi, M.D., MBA, as the new president and CEO, and Marc Beer as the new chairman of the board of directors of Minerva Neurosciences. The company was founded in 2013 by the merger of Cyrenaic Pharmaceuticals and Sonkei Pharmaceuticals.

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Fidelity Biosciences, Regenx Biosciences launch Dimension Therapeutics

Friday, November 1, 2013 11:10 AM

Fidelity Biosciences and Regenx Biosciences have formed Dimension Therapeutics, a gene therapy company focused on developing novel treatments for rare diseases. Dimension will focus on advancing its platform of gene therapy programs in rare diseases through clinical development, starting with lead programs in hemophilia and building out a product engine for AAV therapeutics.

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PhRMA to open Middle East and Africa regional office at DuBiotech, UAE

Wednesday, October 9, 2013 02:09 PM

Pharmaceutical Research and Manufacturers of America (PhRMA) plans to establish its Middle East and Africa regional office within Dubai Biotechnology and Research Park (DuBiotech), a free zone dedicated to facilitating and fostering the growth of the life sciences industry in the UAE and a member of Tecom Investments, a developer and operator of business parks.

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Third Rock Ventures expands, strengthens team

Wednesday, May 15, 2013 09:38 AM

Third Rock Ventures, a venture capital firm focused on building healthcare companies, has expanded and strengthened its team with several appointments and role changes. These additions allow Third Rock to continue to support the launch of new companies focused on disruptive areas of science and medicine, the maturation and development of its current portfolio companies and the overall strategy and direction of the firm.

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Sanofi, Transgene form long-term collaboration for production of immunotherapy treatments

Monday, March 25, 2013 12:24 PM

Global healthcare company Sanofi and biopharmaceutical company Transgene have signed a collaboration agreement for the creation of a new state-of-the-art industrial platform dedicated to the production of immunotherapy products including Transgene's therapeutic products.

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Xenon appoints Bridger as executive vice president, R&D

Thursday, February 14, 2013 08:00 AM

Xenon Pharmaceuticals, a clinical genetics-based drug discovery and development company focused on rare diseases, has appointed Gary J. Bridger, PhD, as executive vice president of research and development.

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CEO of Sanofi designated as new president elect of EFPIA

Wednesday, November 7, 2012 01:55 PM

The European Federation of Pharmaceutical Industries and Associations (EFPIA), which represents the pharmaceutical industry operating in Europe, has designated Christopher A. Viehbacher, CEO of Sanofi, as the new president elect of EFPIA. He will take up the position as of June 2013 for a two year term.

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Alnylam, Genzyme to develop and commercialize RNAi therapeutics in Asia

Monday, October 22, 2012 12:01 PM

Alnylam Pharmaceuticals, a biopharmaceutical company based in Cambridge, Mass., and Genzyme, a Sanofi company, have formed an exclusive alliance to develop and commercialize RNAi therapeutics targeting transthyretin (TTR) for the treatment of transthyretin-mediated amyloidosis (ATTR) in Japan and other Asia-Pacific countries.

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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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