Articles Published in 2011

Synexus names Pilgrim chairman

Monday, October 17, 2011 01:01 PM

Alan Pilgrim has taken over as chairman of Synexus from Trevor Jones, who continues on the board as a director and becomes president of the Synexus’ Scientific advisory board.

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Lupus Research Institute launches global research initiative

Monday, October 17, 2011 12:36 PM

The Lupus Research Institute (LRI) has launched a major international initiative aimed at attracting the highest level scientists to conduct pioneering research to discover the fundamental root causes of lupus, explore the potential for a cure, and transform the field of lupus research.

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vRad partners with ICON Medial imaging

Monday, October 17, 2011 12:25 PM

Virtual Radiologic (vRad), a technology-enabled national radiology practice, has reported a radiology partnership with ICON Medical Imaging, the medical imaging division of ICON.

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DIA names director of DIA India

Monday, October 17, 2011 12:00 PM

DIA has named Kaushik Desai as director of DIA India. Kaushik brings to DIA both a deep knowledge of the global regulatory framework and the pharmaceutical environment in India as well as a passion for the vision and mission of the association.

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ChemoCentryx initiates phase II CCX168 trial

Monday, October 17, 2011 11:49 AM

ChemoCentryx has initiated a phase II clinical trial for CCX168, an orally-administered small molecule for the treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), a disease which can lead to renal and pulmonary failure.  CCX168 specifically targets the C5a receptor (C5aR), a potent pro-inflammatory mediator that is involved in AAV as well as several other autoimmune diseases.  This randomized, double-blind, placebo-controlled trial will evaluate the safety and tolerability of CCX168 in patients with ANCA-associated renal vasculitis while assessing the potential for reducing or eliminating the use of corticosteroids in these patients.

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VIVUS resubmits NDA for Qnexa

Monday, October 17, 2011 11:37 AM

VIVUS has resubmitted the New Drug Application (NDA) for Qnexa to the FDA. The resubmission follows an agreement reached in September 2011 with officials of the endocrine and metabolic division of the FDA on the filing strategy for Qnexa. The NDA resubmission seeks approval for an initial indication for the treatment of obesity, including weight loss and maintenance of weight loss for obese patients or overweight patients with weight-related co-morbidities such as hypertension, type 2 diabetes, dyslipidemia, or central adiposity (abdominal obesity). The proposed labeling for Qnexa includes a contraindication for women of childbearing potential.  The NDA resubmission also includes a proposed Risk Evaluation and Mitigation Strategy (REMS).

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ICON names president of DOCS

Monday, October 17, 2011 10:59 AM

ICON has named Colin Stanley president of DOCS, the company’s global resourcing division. Stanley succeeds Mr. Bill Taaffe as president following his retirement earlier this year.

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Concerns grow over CMS missing Sunshine Act draft deadline as data collection start date looms

Monday, October 17, 2011 08:02 AM

Industry groups have expressed concern about the Centers for Medicare and Medicaid Services (CMS) missing its deadline for drafting regulations to implement the so-called sunshine law, which requires sponsors to publicly disclose payments to physicians and teaching hospitals. Pharmaceutical and biotechnology companies must begin collecting data to comply with the law in less than 11 weeks.

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Pearl IRB expands into compliance and consulting

Monday, October 17, 2011 08:00 AM

Indianapolis-based Pearl IRB is expanding. The commercial institutional review board, launched just last year, is now adding a regulatory and compliance division, as well as a consulting division that will focus on helping life sciences startups.

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Capstone Therapeutics cuts 14 jobs

Friday, October 14, 2011 01:36 PM

Capstone Therapeutics plans to preserve cash during ongoing discussions with potential partners regarding AZX100 in dermal scarring. The company will reduce staff from its current 18 full-time employees to a core of four individuals covering required regulatory and financial functions at substantially reduced compensation.

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