Global News

FDA grants accelerated approval for Sirturo for multi-drug resistant TB

Wednesday, January 2, 2013 03:13 PM

The FDA has granted accelerated approval to Janssen Therapeutics’ Sirturo (bedaquiline) tablets for the treatment of pulmonary multi-drug resistant tuberculosis (MDR-TB) as part of combination therapy in adults. The accelerated approval is based on the surrogate endpoint of time to sputum culture conversion.

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Abbott completes separation of research-based pharmaceuticals business

Wednesday, January 2, 2013 02:09 PM

Global healthcare company Abbott Laboratories has completed the separation of its research-based pharmaceuticals business, which became AbbVie, a new independent biopharmaceutical company. AbbVie began trading independently on the New York Stock Exchange on Jan. 2, 2013, under the symbol "ABBV."

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The CenterWatch Monthly, January 2013

Wednesday, January 2, 2013 01:39 PM

Parexel celebrates 30 years of change, growth

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Perrigo acquires remaining stake in Cobrek Pharmaceuticals

Wednesday, January 2, 2013 12:18 PM

Perrigo, a global provider of healthcare products, has signed a definitive merger agreement with Cobrek Pharmaceuticals, a Chicago-based, privately held drug development company, and has acquired the company for approximately $45 million on a cash free and debt free basis.

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Parexel acquires Liquent

Wednesday, January 2, 2013 09:49 AM

Parexel International has acquired all of the outstanding equity securities of Liquent, a global provider of Regulatory Information Management (RIM) solutions. Liquent provides an integrated platform of software solutions for regulatory submissions and product registration management, as well as a range of complementary business process outsourcing capabilities.

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Elan completes demerger of Prothena

Friday, December 21, 2012 02:40 PM

Dublin-based Elan has completed the separation of a substantial portion of its drug discovery business (the Prothena Business) into a new independent, publicly traded company, Prothena. Incorporated in Ireland, Prothena commenced trading on the NASDAQ Global Market as of Dec. 21.

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Synteract to acquire Harrison Clinical Research

Thursday, December 20, 2012 10:37 AM

CRO Synteract, a portfolio company of San Francisco-based Gryphon Investors, has agreed to acquire Harrison Clinical Research (HCR).

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WuXi PharmaTech, PRA form joint venture for Chinese market

Thursday, December 20, 2012 10:32 AM

CRO WuXi PharmaTech, with operations in China and the U.S., and CRO PRA have signed a joint venture agreement to offer a broad platform of phase I-IV clinical trial services in China, Hong Kong and Macau, including clinical trial monitoring, project management, regulatory strategy and submissions, data management, biostatistics, drug safety reporting and medical monitoring.

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Merck, GE Healthcare collaborate on imaging biomarkers for BACE inhibitor program

Wednesday, December 19, 2012 01:18 PM

Merck and GE Healthcare have formed a clinical study collaboration, license and supply agreement for use of [18F]Flutemetamol, an investigational positron emission tomography (PET) imaging agent, to support Merck's development of MK-8931, a novel oral beta amyloid precursor protein site cleaving enzyme (BACE) inhibitor and Merck's lead investigational candidate for Alzheimer's disease (AD).

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Stansfield joins PharmaNet/i3 as executive vice president, clinical operations

Wednesday, December 19, 2012 11:39 AM

PharmaNet/i3, inVentiv Health’s clinical segment and a provider of clinical development services, has appointed Dr. Susan C. Stansfield as executive vice president of clinical operations for phase II-IV development in Europe, Middle East and Africa (EMEA), Asia-Pacific and Latin America. 

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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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