DIA Biosimilars 2013

Articles Published in 2008

CDER's Woodcock Details Expanded Authority at Post-Approval Summit

Friday, May 16, 2008 10:02 AM

Opening the Post-Approval Summit at Harvard on May 14 and 15, keynote speaker Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), outlined her agency’s expanded authorities in the area of post-approval research oversight brought about by the passage of the FDA Amendments Act (FDAAA) into law at the end of March.

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Cenduit: Now with Patient Reminders

CWWeekly May 12th 2008 Issue

Friday, May 16, 2008 09:37 AM

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CRF Health – eCOA Forum

eResearch's Profits Soar

Thursday, May 15, 2008 11:42 AM

Philadephia, Penn.-based eClinical company eResearch Technology (eRT) saw nearly a 60% increase in its first quarter revenues with $33.7 million compared to $21.1 million in the first quarter of 2007. Its net income soared 155.6% to $5.7 million (or $0.11 per share) from $2.2 million (or $0.04) a year earlier.

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CenterWatch Monthly May 2008 Issue

Wednesday, May 14, 2008 11:17 AM

Eli Lilly, Wyeth, Schering-Plough Rated Top Pharma Companies in Europe

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Criterium Registers in Canada, Creates New Positions

Tuesday, May 13, 2008 05:25 AM

Saratoga, N.Y.-based contract research organization (CRO) Criterium is planning to open an office in Toronto. The move was client-driven and will be where the company’s newly appointed director of global affairs, Lawrence Reiter, Ph.D., is based.

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Project Delays Hurt etrials in First Quarter

Monday, May 12, 2008 11:32 AM

Morrisville, N.C.-based eClinical company etrials reported another challenging quarter with a drop in net service revenue of $3.7 million for the first quarter of 2008 compared to $4.1 million reported in 2007. Quarter over quarter, the company’s profit losses widen with a $2.0 million net loss for the quarter (or $0.19 per share) compared with a loss of $900,000 during the first quarter of 2007. etrials stated that its drop in revenue was partly due to new project delays, resulting in about $1 million in lost revenue.

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CWWeekly May 5th 2008 Issue

Friday, May 9, 2008 10:18 AM

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Gene Therapy Shows Promise for Rare Childhood Blindness

Tuesday, May 6, 2008 04:45 PM

Targeted Genetics reported positive results from a phase I/II trial of its RPE65 gene therapy for the treatment of retinal dystrophy due to Leber’s congenital amaurosis (LCA). LCA is a rare eye disease that causes severe vision loss or blindness. The disease is genetically inherited and usually manifests itself at birth or in early infancy. There are thought to be 3,000 people in the U.S. with the disease; however, the technology has the potential to treat a variety of eye diseases such as macular degeneration which afflicts 1.25 million people in the U.S. alone.

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PharmaNet Sees Profits Sink in Q1 due to Cancellations

Monday, May 5, 2008 02:14 PM

Princeton, N.J.-based contract research organization (CRO) PharmaNet Development Group dropped out of the black with a reported net loss of $10.1 million for the first quarter of 2008, primarily due to canceled contracts. PharmaNet cut its guidance for 2008 and its stock plunged 28% on May 1 to $17.10, far off its 52-week high of $43.05.

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CWWeekly April 28th 2008 Issue

Friday, May 2, 2008 03:44 PM

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CWWeekly

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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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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