DIA Biosimilars 2013

EMA

Clinical trials register initiated in EU

Thursday, March 24, 2011 01:42 PM

An online register giving the public access to information on clinical trials authorized in the 27 E.U. member states as well as Iceland, Liechtenstein and Norway has been launched by the EMA, according to PharmaTimes.

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Cenduit: Now with Patient Reminders

EMA restricts former chief’s activities

Wednesday, March 23, 2011 12:03 PM

Former EMA executive director Thomas Lonngren is facing regulatory issues regarding his plans to consult for pharma companies.

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CRF Health – eCOA Forum

Talecris Biotherapeutics receives EU orphan drug designation for Plasmin

Friday, March 11, 2011 11:56 AM

Talecris Biotherapeutics has been granted orphan drug designation by the European Commission for the development of Plasmin (human) to treat acute peripheral arterial occlusion (aPAO). Talecris is currently investigating Plasmin in a phase II clinical trial designed to assess its ability to treat aPAO, a condition in which arterial blood flow to the extremities, usually the legs, is blocked by a clot. 

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EMA seeks public comment on biomarker

Wednesday, March 2, 2011 01:49 PM

The European Medicines Agency (EMA) is seeking public comment on the first clinical biomarker the agency has approved for use in humans, according to a report in PharmaTimes.

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Former EMA director's new position raises conflict of interest questions

Wednesday, March 2, 2011 08:14 AM

The European Medicines Agency (EMA)’s decision to allow its former executive director, Thomas Lonngren, to take up an advisory role within the private pharmaceutical sector—just weeks after leaving his position at EMA—risks conflicts of interest, campaigners have claimed.

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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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