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Robert Blum receives 2014 Lou Gehrig Iron Horse Award

Thursday, December 4, 2014 02:14 PM

Cytokinetics has announced that the company's president and CEO, Robert Blum, received the 2014 Lou Gehrig Iron Horse Award from ALS Therapy Development Institute (ALS.net).

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FDA issues final rule on changes to pregnancy and lactation labeling information

Thursday, December 4, 2014 02:03 PM

The FDA has published a final rule that sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products. The new content and formatting requirements will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding.

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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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CluePoints wins award for Best Technological Development in Clinical Trials

Thursday, December 4, 2014 01:21 PM

CluePoints, a Cambridge, Mass.-based provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, was awarded Best Technological Development in Clinical Trials at the 2014 Scrip Awards. The award, sponsored by the MCT Congress, recognizes CluePoints in the Cloud as the ultimate quality oversight and risk-based monitoring (RBM) application developed to determine the quality and integrity of clinical trials data.

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Report: Parkinson’s treatment pipeline targeting functional processes over genes

Thursday, December 4, 2014 12:35 PM

The Parkinson’s disease (PD) treatment pipeline is characterized by a high degree of innovation and diverse molecular targets, with 37% of 302 products holding first-in-class status, according to New York-based business intelligence provider GBI Research.

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BTG acquires PneumRx for up to $475 million

Thursday, December 4, 2014 12:34 PM

London-based BTG will acquire PneumRx, a Mountain View, Calif.-based interventional pulmonology company in a deal worth up to $475 million, based on an initial consideration of $230 million and up to $245 million in performance-related milestone payments. BTG is an international specialist healthcare company active in interventional medicine and specialty pharmaceuticals. 

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Catalent, Valerion collaborate on orphan genetic disorder treatments

Thursday, December 4, 2014 12:32 PM

Catalent Pharma Solutions, a Somerset, N.J.-based global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, is collaborating with Valerion Therapeutics, a Concord, Mass.-based emerging science-driven company focused on the development of bio-therapeutics for orphan genetic diseases, to develop Valerion's two lead product candidates.

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NIH awards $20M for drug delivery system to prevent HIV infection in women

Thursday, December 4, 2014 12:30 PM

The University of Texas Medical Branch (UTMB) is part of a collaboration led by the Oak Crest Institute of Science that received a $20 million grant from the NIH to develop a novel intravaginal ring capable of delivering powerful antiretroviral drugs to prevent the spread of sexually transmitted HIV in women. The total award to UTMB is approximately $2.5 million.

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Diagnostics Development Hub to boost biomedical research in Singapore

Thursday, December 4, 2014 12:25 PM

Singapore's biomedical research sector received a major boost with the launch of a new Diagnostics Development (DxD) Hub. The DxD Hub aims to develop medical diagnostics as one part of the medical technologies industry, improve healthcare through development of diagnostic solutions and accelerate production of new diagnostics devices. Diagnostics is one of four innovation clusters shortlisted to be funded under the $200 million Innovation Cluster Program (ICP) launched Oct. 2013.

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BioClinica names John Hubbard CEO

Wednesday, December 3, 2014 01:05 PM

BioClinica, a Pennsylvania-based CRO, has appointed John Hubbard, Ph.D., FCP, as CEO and to its board of directors. Hubbard will assume the CEO position on Jan. 5, 2015 from Mark Weinstein.

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December 15

Cancer Treatment Centers of America chooses WCG as its exclusive IRB, sheds five local hospital IRBs

Five southern research groups form public-private network to help save time, money for clients with early-stage biologics

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The CenterWatch Monthly

December

Growing adoption of feasibility review committees
Early reports cite fewer amendments, improved cycle time

AMCs vying to better compete for industry trials
Working to conquer study start-up delays, IRB review process

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November

Private equity driving dynamic CRO growth
Enables CROs to pursue long-term strategies, while giving the space credibility

Baby boomers poised to reshape clinical trials industry
Millions of tech-savvy consumers already track their health, expect new treatments as they age

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