Theorem Clinical Research

Genzyme

Pharming appoints Dr. Perry Calias chief scientific officer

Thursday, February 19, 2015 02:17 PM

Pharming Group has appointed Dr. Perry Calias chief scientific officer. Calias will have overall responsibility for the company's new enzyme replacement therapy (ERT) programs, achieving the scientific milestones set in the business plan, enhancing the IP portfolio, overseeing new product development and contributing to the overall strategic direction of the company.

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Quest Diagnostics

Voyager Therapeutics, Genzyme collaborate on CNS disorders

Thursday, February 12, 2015 01:01 PM

Voyager Therapeutics, a gene therapy company headquartered in Cambridge, Mass. developing treatments for diseases of the central nervous system (CNS), and Genzyme, a Sanofi company and gene therapy pioneer, have announced a major strategic collaboration to discover, develop and commercialize novel gene therapies for severe CNS disorders. The collaboration will leverage Genzyme’s long-standing commitment and experience in adeno-associated virus (AAV) gene therapy and Voyager’s AAV product engine to develop breakthrough therapies for patients suffering from severe CNS disorders.

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First MS patients in the U.S. receive Genzyme’s Lemtrada following FDA approval

Thursday, December 4, 2014 01:43 PM

Genzyme, a Sanofi company, has announced that the first U.S. patients have initiated treatment with Lemtrada (alemtuzumab) in the commercial setting following its Nov. 14 FDA approval for the treatment of patients with relapsing forms of multiple sclerosis (MS). Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.

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Sanofi board ousts CEO Viehbacher

Thursday, October 30, 2014 08:46 AM

Paris-based biopharmaceutical company Sanofi ousted CEO Chris Viehbacher Wednesday, just two days after reporting disappointing quarterly earnings.

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Fidelity Biosciences and Atlas Venture launch Unum Therapeutics

Wednesday, October 22, 2014 11:28 AM

Fidelity Biosciences and Atlas Venture, with participation from Sanofi-Genzyme BioVentures, have launched Unum Therapeutics, a company developing cellular immunotherapy to treat cancer. Fidelity Biosciences invests venture capital in biopharmaceutical, medical technology, healthcare information technology and healthcare service companies, while Atlas Venture is an early-stage investor. All three are based in Cambridge, Mass.

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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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CWWeekly

March 2

Huntingdon Life Sciences-Harlan prepares for rebranding and U.S. expansion to compete with early phase CROs Covance, CRL

Patients' increased sharing of clinical trial experiences through social media can help sponsors improve outcomes, enrollment

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The CenterWatch Monthly

March

Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

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The CenterWatch Monthly

February

Study grants market breaks $13 billion
Volume of clinical activity rising while growth in grant spending slows

Revisiting eClinical Technology Solutions Adoption
While use of established solutions grows, sponsors hesitate on newer tools

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