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ACRO launches video series

Tuesday, May 14, 2013 01:35 PM

The Association of Clinical Research Organizations is introducing a new series of videos featuring the leaders of prominent healthcare interest groups.

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Harlan Laboratories expands facilities

Tuesday, May 14, 2013 01:33 PM

CRO Harlan Laboratories, which also provides research models, has expanded its specialty research production facilities in Indianapolis and Livermore, Calif. This expansion more than doubles the number of isolators at these sites, allowing Harlan to meet growing customer demand for its immunocompromised models.

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Wierman appointed Theorem vice president of biopharmaceutical development

Monday, May 13, 2013 08:00 AM

Theorem Clinical Research, a King of Prussia, Penn.-based, mid-sized provider of comprehensive clinical research and development services, has appointed Connie Wierman as vice president of biopharmaceutical development. Wierman leads the company’s oncology therapeutic focus for the biopharmaceutical business unit.

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Former FDA official Tim Cote joins Emmaus Medical as regulatory advisor

Friday, May 10, 2013 08:00 AM

Emmaus Medical, a specialty pharmaceutical and regenerative medicine company, has appointed Timothy Cote, M.D., MPH, former director of the Office of Orphan Product Development of the FDA, as its regulatory advisor. Cote will advise Emmaus on the regulatory pathway for the company's sickle cell disease treatment.

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Quintiles prices IPO at $40 per share

Thursday, May 9, 2013 11:40 AM

Quintiles has announced the pricing of its initial public offering of 23,684,210 shares of its common stock at a price to the public of $40.00 per share. The shares of Quintiles common stock are expected to begin trading on the New York Stock Exchange under the single-letter symbol "Q” on May 9, 2013.  

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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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