Articles Published in 2012

Orexo submits NDA for Zubsolv for opiod dependence

Friday, September 7, 2012 01:41 PM

Orexo, an emerging specialty pharmaceutical company, has submited a New Drug Application (NDA) for a novel combination product of buprenorphine and naloxone for treatment of opioid dependence, a condition affecting over two million Americans.

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Charles River opens new biomedical diagnostic facility

Friday, September 7, 2012 12:30 PM

Charles River Laboratories, a global preclinical CRO, has opened its new biomedical diagnostic testing facility in Wilmington, Mass.

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Galenea receives $3M to develop translational EEG biomarkers for schizophrenia

Friday, September 7, 2012 12:22 PM

Researchers at Galenea, based in Cambridge, Mass., and collaborator Dr. Kevin Spencer of the VA Boston Healthcare System and Harvard Medical School, have been awarded a five-year, $3 million grant from the National Institute of Mental Health (NIMH).

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ERT launches enhanced platform to streamline data collection, analysis and processing

Friday, September 7, 2012 11:57 AM

ERT, a global technology-driven provider of health outcomes services, has launched an enhanced clinical research workflow technology designed to streamline data collection, analysis and processing in clinical trials.

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SFJ, Pfizer collaborate on phase III trial of dacomitinib in lung cancer

Friday, September 7, 2012 11:21 AM

The SFJ Pharmaceuticals Group (SFJ), a global drug development group of companies, has entered into a collaborative development agreement with Pfizer to conduct a phase III clinical trial of Pfizer's investigational pan-HER (pan-human epidermal growth factor receptor) inhibitor, dacomitinib (PF-00299804).

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Spectrum completes acquisition of Allos

Friday, September 7, 2012 10:59 AM

Spectrum Pharmaceuticals (SPPI), an Irvine, Calif.-based biotech focused on hematology and oncology, has completed its acquisition of Allos Therapeutics, a Westminster, Colo.-based developer of small molecule drugs.

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Faster approval: oncology drugs in the U.S., non-oncology drugs in the E.U.

Friday, September 7, 2012 10:45 AM

Approval times for new oncology drugs in the U.S. during the last decade were shorter than approval times for non-oncology products, while the reverse was the case in the E.U., according to a study recently completed by the Tufts Center for the Study of Drug Development.

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Jazz Pharmaceuticals to sell women's health business to Meda

Friday, September 7, 2012 10:31 AM

Jazz Pharmaceuticals, a specialty pharmaceutical company based in Dublin, has inked an agreement to sell its women's health business to Meda, an international specialty pharmaceutical company based in Sweden, for $95 million in cash.

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Pulmatrix appoints Robert Clarke as CEO

Thursday, September 6, 2012 08:28 AM

Pulmatrix, a Lexington, Mass.-based clinical stage biotechnology company, has promoted Robert Clarke, Ph.D., to the position of CEO and to the board of directors.

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FDA approves Pfizer’s new orphan drug for chronic myelogenous leukemia

Thursday, September 6, 2012 08:25 AM

The FDA has approved Pfizer’s Bosulif (bosutinib) to treat chronic myelogenous leukemia (CML), a blood and bone marrow disease that usually affects older adults.

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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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The CenterWatch Monthly

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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