Articles Published in 2013

Janssen Biotech’s Simponi receives FDA approval for ulcerative colitis

Monday, May 20, 2013 08:00 AM

The FDA has approved Janssen Biotech’s Simponi (golimumab) for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine.

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PPD earns award for innovation in training and development

Monday, May 20, 2013 08:00 AM

Pharmaceutical Product Development (PPD), a global CRO, has been named by Skillsoft as a winner of the 2013 Skillsoft Perspectives Innovation Award for Empowering Learning Cultures in the Enterprise.

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PRA opens new facility in Wales, creates 100 graduate-level jobs

Friday, May 17, 2013 02:03 PM

PRA, a global CRO, has officially opened its new facility in Swansea, Wales. The expansion is being supported with $1.9 million business finance from the Welsh government.

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FDA approves GSK’s Breo Ellipta to treat COPD

Friday, May 17, 2013 01:25 PM

The FDA has approved GlaxoSmithKline and Theravance’s Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations. 

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Amgen, Novartis join Atlas Venture Fund IX as corporate strategic partners

Friday, May 17, 2013 12:25 PM

Atlas Venture, an early-stage venture capital firm that invests in technology and life sciences companies, has entered into Corporate Strategic Partnership (CSP) agreements with both Amgen, through its venture capital fund, Amgen Ventures, and Novartis. The CSP agreements are in conjunction with the closing of Atlas IX in which Amgen Ventures and Novartis are new limited partners. 

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Bayer to acquire Steigerwald Arzneimittelwerk

Friday, May 17, 2013 11:56 AM

Bayer has signed an agreement to acquire 100% of the shares of Steigerwald Arzneimittelwerk, a Darmstadt, Germany-based privately held pharmaceutical company specializing in pharmacy-only herbal medicines.

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Regenesis Biomedical names Scott Brooks as CEO

Friday, May 17, 2013 11:28 AM

The board of directors of Regenesis Biomedical, a privately held medical technology company focused on tissue regeneration, has unanimously elected Scott Brooks as the next chief executive officer and member of the board of directors, succeeding Virginia Rybski. Brooks will assume his new role immediately.

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BioDuro opens state-of-the-art discovery lab in Shanghai

Friday, May 17, 2013 10:59 AM

BioDuro, a drug discovery services company owned by PPD, has opened a new state-of-the-art laboratory in Shanghai, strengthening its ability to provide biopharmaceutical clients an extensive range of customized drug discovery services in Asia Pacific.

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PCORI opens second year of research funding with $81M

Friday, May 17, 2013 10:30 AM

The Patient-Centered Outcomes Research Institute (PCORI), an independent, non-profit organization, opened its second year of funding of patient-centered comparative clinical effectiveness research (CER), revising its broad funding announcements to clarify key review criteria and application definitions.

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Chiltern appoints Niewel and Bull to senior positions

Thursday, May 16, 2013 08:00 AM

Chiltern International, a global CRO based in the U.K., has appointed Dr. Manuela Niewel as medical director and Lisa Bull as director of strategic partnerships.

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