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Clinical Intelligence

Boston Scientific enrolls first patient in coronary stent study featuring bioabsorbable polymer coating

Friday, November 30, 2012 12:13 PM

The first patient has been enrolled in Boston Scientific’s EVOLVE II clinical trial, designed to further assess the safety and effectiveness of the SYNERGY Stent System and support FDA and Japanese regulatory approvals for the treatment of atherosclerotic coronary lesions.  

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ACRP Certification Program - July 31st

Common canine virus may lead to new vaccines for deadly human diseases

Friday, November 30, 2012 11:21 AM

Researchers at the University of Georgia have discovered that a virus commonly found in dogs may serve as the foundation for the next great breakthrough in human vaccine development.

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CRF Health – eCOA Forum

FDA approves Cometriq to treat rare type of thyroid cancer

Thursday, November 29, 2012 08:00 AM

The FDA has approved Cometriq (cabozantinib) to treat medullary thyroid cancer that has spread to other parts of the body.

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Almirall’s Constella approved in Europe for IBS-C

Wednesday, November 28, 2012 12:20 PM

The European Commission has granted marketing authorization to Almirall’s Constella (linaclotide 290mcg) for the symptomatic treatment of moderate to severe Irritable Bowel Syndrome with Constipation (IBS-C) in adults . This approval follows the positive recommendation received from the European Committee for Medicinal Products for Human Use (CHMP) in September.

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Savara's AeroVanc granted Orphan Drug status for MRSA lung infection in CF

Tuesday, November 20, 2012 11:23 AM

The FDA has granted orphan drug status to Savara Pharmaceuticals’ AeroVanc (vancomycin hydrochloride inhalation powder) for the treatment of pulmonary methicillin-resistant Staphylococcus aureus (MRSA) infection in cystic fibrosis (CF).

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Abbott announces phase III Hep C program details

Friday, November 16, 2012 02:25 PM

Abbott Laboratories, a global healthcare company, has released details on its phase III hepatitis C registration program following promising results from its phase IIb clinical trial, known as Aviator.

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TissueGene completes enrollment in phase II TG-C study of in knee osteoarthritis

Thursday, November 15, 2012 08:00 AM

TissueGene, is a Rockville, Md.-based biopharmaceutical company focused on developing novel regenerative therapies, has completed patient enrollment for a U.S. phase II clinical trial of TG-C in patients with severe osteoarthritis of the knee. 

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Protein predicts diabetes risk many years in advance

Wednesday, November 14, 2012 03:05 PM

When a patient is diagnosed with type 2 diabetes, the disease has usually already progressed over several years and damage to areas such as blood vessels and eyes has already taken place. To find a test that indicates who is at risk at an early stage would be valuable, as it would enable preventive treatment to be put in place.

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FDA grants Soligenix Fast Track designation for SGX203 for Crohn's disease

Friday, November 9, 2012 12:44 PM

Soligenix, a development stage biopharmaceutical company based in Princeton, N.J., announced that its drug SGX203, for the treatment of mild-to-moderate pediatric Crohn's disease, has received Fast Track designation from the FDA.

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AcelRx doses first patients in ARX-04 phase II study in pain

Wednesday, November 7, 2012 03:09 PM

AcelRx Pharmaceuticals, a specialty pharmaceutical company focused on the treatment of acute and breakthrough pain, has dosed the first subjects in a phase II, placebo-controlled, dose-finding study of its ARX-04 sufentanil NanoTab product candidate. 

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June 17

New CISCRP study finds patient perceptions of trial participation safety, motives greatly improved

PwC: Volume and value of pharma, diagnostics deals soar in first quarter, as CRO sector waits on sidelines

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June

Operating environment spurs out-of-the-box ideas
High cost, low success rates drive some sponsors to new monitoring, protocol design, patient-centric initiatives

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Now flush with cash, many PE investors readying to cash out

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May

INC Research, PPD, inVentiv named top CROs
Yet most CROs slipping in ability to manage site relationships

R&D cuts by sponsors spur more collaboration, innovation
New strategies share pipeline activity costs

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