Articles Published in 2011

FDA approves Combivent Respimat for COPD

Tuesday, October 11, 2011 12:11 PM

Boehringer Ingelheim Pharmaceuticals has reported that the FDA has approved COMBIVENT RESPIMAT, a new, propellant-free inhaler product that uses a slow-moving mist to deliver the same active ingredients of COMBIVENT Inhalation Aerosol in a metered dose inhaler (COMBIVENT MDI). COMBIVENT RESPIMAT will be available for patients in mid-2012.

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Hybrigenics, Servier ink license and research agreement

Tuesday, October 11, 2011 11:38 AM

Hybrigenics and Servier have signed a license and research collaboration agreement in the field of deubiquitinating enzymes (DUBs) applied to oncology, neurology, psychiatry, rheumatology, ophthalmology, diabetes and cardiovascular diseases.

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Sponsors using partnerships to speed development

Tuesday, October 11, 2011 11:14 AM

Responding to strong and growing pressure to reduce development times and increase the output of new medicines, drug companies are engaging in innovative partnerships that are leading to, among other things, more molecular entities entering phase I trials and shorter study times, according to a panel of leaders from the drug research industry recently convened by the Tufts Center for the Study of Drug Development.

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Quintiles names global head of clinical & data operations

Tuesday, October 11, 2011 10:59 AM

Quintiles has named Steven Skolsky global head of its clinical & data operations (CDO) unit, the core of the company’s clinical development division that monitors the clinical conduct at research sites and collects and manages data from thousands of patients in hundreds of clinical trials conducted around the world.

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NIHR launches first two translational partnerships in U.K.

Tuesday, October 11, 2011 10:38 AM

NIHR translational research partnerships bring together investigators at the U.K.’s leading academic and NHS centers to support collaboration with the life sciences industry in early and exploratory development of new drugs and other interventions.

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National Association of Professional Women honors Christine Pierre

Tuesday, October 11, 2011 09:19 AM

Christine K. Pierre, president and founder of Ellicott City, Md.-based RxTrials, has been named a Professional Woman of the Year by the National Association of Professional Women (NAPW), VIP division. The honor recognizesPierre’s “outstanding leadership and commitment” within her profession, according to the New York-based network community for professional women.

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Carlyle Partners, Hellman & Friedman to acquire PPD for $3.9 billion, take the CRO private

Monday, October 10, 2011 08:02 AM

It’s official: Large equity investors Carlyle Partners and Hellman & Friedman Capital Partners are buying publicly traded PPD, taking the CRO private.

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Massachusetts leads U.S. in biotech R&D jobs

Monday, October 10, 2011 08:00 AM

Though it may be small, the state of Massachusetts continues to lead the U.S. in biotechnology research and development jobs, with 26,807 such positions. And companies in the state garnered almost a quarter of all venture capital flowing into the sector nationally, an all-time high share for Massachusetts. And the pace of employment growth in the overall biopharma industry is second only to much larger California.

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AstraZeneca cuts hundreds of jobs in US

Friday, October 7, 2011 02:46 PM

AstraZeneca will streamline portions of its U.S. commercial business as part of the company's strategy to operate its business more effectively and efficiently to best serve patients in the United States. The changes will enable the company to compete in a challenging environment, including pricing pressures and the continuing growth of generic medicines.

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FDA approves Cialis for treatment of BPH

Friday, October 7, 2011 12:01 PM

The FDA has approved Cialis (tadalafil) to treat the signs and symptoms of benign prostatic hyperplasia (BPH), a condition in which the prostate gland becomes enlarged, and for the treatment of BPH and erectile dysfunction, when the conditions occur simultaneously. Cialis was approved in 2003 for the treatment of ED.

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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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