United States

LabConnect expands North American headquarters in Seattle

Wednesday, May 8, 2013 12:05 PM

LabConnect, a provider of global central laboratory testing services, is expanding its North American headquarters in Seattle. The success of LabConnect’s Scientific Operations Support (SciOps) team and overall company growth are behind its move to larger quarters in Seattle’s historic district.

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NeuroPhage raises $6.4M in additional financing

Monday, May 6, 2013 02:40 PM

NeuroPhage Pharmaceuticals, a company developing breakthrough therapies for neurodegenerative diseases, has raised $6.4 million in a private equity financing round. Mérieux Développement led the financing with participation from all current Neurophage investors, including Shire.  

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FDA grants Breakthrough Therapy Scioderm's SD-101 for epidermolysis bullosa

Monday, May 6, 2013 12:29 PM

Scioderm’s investigational product SD-101 has received Breakthrough Therapy designation from the FDA for the treatment of inherited epidermolysis bullosa (EB). 

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Raptor Pharma's Procysbi receives FDA approval for nephropathic cystinosis

Friday, May 3, 2013 02:02 PM

The FDA has approved Raptor Pharmaceutical’s Procysbi(cysteamine bitartrate) delayed release capsules for the treatment of nephropathic cystinosis in adults and children six years and older.

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FDA grants Genmab’s daratumumab Breakthrough Therapy Designation

Friday, May 3, 2013 11:55 AM

The FDA has granted Breakthrough Therapy Designation for Genmab’s daratumumab for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or who are double refractory to a PI and IMiD. 

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Catalent Biologics opens new single-use biomanufacturing Center of Excellence

Monday, April 29, 2013 01:58 PM

Catalent Pharma Solutions, a provider of drug and biologic development services, has officially open its new, state-of-the-art biomanufacturing Center of Excellence in Madison, Wisc.

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ImageIQ, IMARC Research form co-marketing partnership

Monday, April 29, 2013 09:40 AM

ImageIQ, an imaging CRO based in Cleveland, Ohio, and IMARC Research, a Strongsville, Ohio-based CRO offering monitoring, auditing and training services, have formed a partnership that will strengthen the abilities of both organization’s clients to manage the complexities of imaging within clinical trials, and to enhance FDA approvals by ensuring that scientific data is optimized and that processes are compliant.

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Halozyme initiates randomized phase II trial of PEGPH20 in pancreatic cancer

Thursday, April 25, 2013 08:00 AM

Halozyme Therapeutics, a San Diego-based biopharmaceutical company, initiated a phase II multicenter, randomized clinical trial evaluating PEGPH20, a proprietary, investigational drug as a first-line therapy for patients with stage IV metastatic pancreatic cancer.

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AUA co-sponsoring public FDA workshops

Wednesday, April 24, 2013 11:58 AM

The American Urological Association (AUA) will co-host two FDA public workshops to address research in the areas of bladder and prostate cancer. The events, free and open to the public, will take place in San Diego on May 5 and May 6, during the AUA's annual scientific meeting.

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PRA Program to create clinical research jobs for new graduates

Wednesday, April 24, 2013 09:23 AM

PRA, a global CRO, has received a $400,000 grant from the Kansas Bioscience Authority (KBA) to create 80 new jobs this year in Kansas. The graduates will be part of the PRA (Preparing for Research Advancement) Program, an innovative career opportunity for new college graduates interested in clinical research and the CRO industry.

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