EMA

PROLOR receives allowance for patent application

Monday, July 11, 2011 12:43 PM

PROLOR Biotech has received a notice of allowance from the U.S. Patent and Trademark Office (PTO) for a patent application covering the company’s CTP platform, which has the potential to extend the duration of activity of virtually all therapeutic proteins. The allowed claims cover CTP-modified compositions of a wide array of classes of therapeutic proteins, including hormones, high affinity protein ligands, proteins that induce or regulate an immune response, proteins that are involved with autocrine and paracrine activities and mimetics of these therapeutic proteins, as well as other types of proteins.

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ClearTrial receives Gartner recognition

Tuesday, May 3, 2011 12:23 PM

ClearTrial, a Chicago-based Clinical Trial Operations software company, has been included in the list of "Cool Vendors" in the "Cool Vendors in Life Sciences, 2011"report by Gartner. Gartner’s vice president Steven Lefebure and Gartner managing vice president Dale Hagemeyer explore key challenges faced by life sciences companies and discuss ClearTrial’s solutions for planning, forecasting, and tracking of clinical projects and financial performance. 

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HemaQuest enrolls first patient in phase II study of HQK-1001

Friday, April 29, 2011 11:34 AM

California-based HemaQuest Pharmaceuticals, a biotechnology company focused on developing small molecule therapeutics to treat hemoglobin disorders, have enrolled the first patient in a randomized multi-dose phase II study of HQK-1001 in patients with sickle cell disease.

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Curemark reports positive results for CM-182 in schizophrenia

Monday, April 25, 2011 12:50 PM

Curemark, a drug research and development company focused on the treatment of neurological diseases, reports that its compound CM-182 demonstrated positive results for schizophrenia in the transgenic chakragati (ckr) model of psychosis. The mouse model screening was performed by CRO Cerca Insights.

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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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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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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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Pharmacy benefits manager Medco Health Solutions buys UBC in $730 million all-cash deal

Monday, August 16, 2010 12:52 PM

Medco Health Solutions, the largest pharmacy benefits manager by revenue in the U.S., has agreed to buy closely held United BioSource Corp. (UBC) for $730 million in an all-cash deal.

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CWWeekly

December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

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January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

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December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

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