DIA Biosimilars 2013

Clinical Intelligence

FDA approves clinical trial of artificial pancreas

Monday, March 19, 2012 03:46 PM

The FDA has approved the first outpatient artificial pancreas trial in the U.S., which will be funded by JDRF, a global organization focused on type 1 diabetes research.

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Cenduit: Now with Patient Reminders

Repligen enrolls first patient in phase I trial of Friedreich’s Ataxia

Monday, March 19, 2012 03:20 PM

Waltham, Mass.-based Repligen has enrolled the first patient in a phase I clinical trial of RG2833 in adult patients with Friedreich’s Ataxia (FA)—a debilitating, life-shortening, degenerative neuro-muscular disorder that currently has no treatment.

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CRF Health – eCOA Forum

diaDexus highlights findings of two PLAC Lp-PLA(2) activity studies

Monday, March 19, 2012 11:49 AM

San Francisco–based diaDexus, a company focused on proprietary cardiovascular diagnostic products, reported highlights from two recent studies evaluating the clinical utility of its PLACR Test for Lp-PLA(2) activity.

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Provectus reports top-line data in phase II psoriasis study

Monday, March 19, 2012 10:39 AM

Provectus Pharmaceuticals, a development-stage oncology and dermatology biopharmaceutical company, reported top-line data for the company's randomized controlled trial of PH-10, a topical aqueous hydrogel, for mild-to-moderate plaque psoriasis.

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Omeros' OMS302 reduces pain and pupil dilation in lens replacement post-op

Friday, March 16, 2012 04:51 PM

Omeros has reported positive data from its phase III clinical trial evaluating OMS302 in patients undergoing intraocular lens replacement surgery.

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Gintuit receives FDA approval for gum tissue regeneration

Thursday, March 15, 2012 06:00 AM

The FDA has approved Gintuit, a cell-based topical product that has been shown to predictably generate new and aesthetically appealing oral soft tissue, according to Organogenesis.

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Creabilis begins phase IIb trial of CT327 in psoriasis

Wednesday, March 14, 2012 09:25 AM

Creabilis, a European biotechnology company specializing in dermatology, inflammation and pain, has initiated a phase IIb global clinical trial of its lead product CT327 in patients with psoriasis vulgaris.

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Tranzyme, Norgine report endpoint failure for ulimorelin

Wednesday, March 14, 2012 09:24 AM

Tranzyme Pharma and Norgine BV, a European specialty pharmaceutical company, reported ULISES 007’s failure to meet its primary and secondary efficacy endpoints.

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HemaQuest raises $13 million for phase IIb study of sickle cell disease

Monday, March 12, 2012 03:49 PM

HemaQuest Pharmaceuticals, a biotechnology company focused on developing small molecule therapeutics to treat hemoglobin disorders, has closed a $13 million extension of its Series B financing.

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Genticel completes recruitment for phase Ib HPV vaccine trial

Wednesday, March 7, 2012 06:15 AM

Genticel, a biopharmaceutical company based in Toulouse and Paris, France, has completed the recruitment of all patients participating in its phase Ib clinical trial evaluating a lyophilized formulation of ProCervix, its candidate therapeutic HPV vaccine, on adult women already infected with human papillomavirus (HPV) genotypes 16 or 18.

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September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

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The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

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The CenterWatch Monthly

September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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