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Oxford BioMedica, Novartis colaborate

Monday, October 13, 2014 08:57 AM

Oxford BioMedica, a U.K. gene and cell therapy company, has signed contracts with Novartis which build on a collaboration between the companies announced May 2013.

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The importance of mentoring

Monday, October 13, 2014 08:00 AM

At critical times in my career, I have benefitted from the wisdom provided by my mentors.

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In appreciation: Felix Gyi will be remembered for his passion, leadership and desire to educate, pay it forward

Monday, October 13, 2014 07:00 AM

Given the choice between talking about Chesapeake Research Review, the highly successful IRB he founded in 1993, or conveying useful information and insights involving bioethics and human subject protection, Felix A. Khin-Maung-Gyi would always choose the latter.

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Endo to acquire Auxilium Pharmaceuticals for $2.6 billion

Friday, October 10, 2014 12:01 PM

Dublin, Ireland-based Endo International has agreed to acquire Chesterbrook, Pa.-based Auxilium Pharmaceuticals. Endo will acquire all outstanding common stock for $33.25 per share in a cash and stock transaction. The boards of directors of both companies have unanimously approved the transaction, valued at $2.6 billion, which includes the repayment and assumption of debt.   

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Lionbridge acquires Clay Tablet Technologies

Friday, October 10, 2014 11:59 AM

Lionbridge Technologies, a Waltham, Mass.-based provider of translation, online marketing, content management and application testing solutions, has acquired Clay Tablet Technologies, a Toronto, Canada-based provider of integration software that connects content management systems with translation processes and technologies.

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Report: Pain medicine market forecast to reach $38 billion by 2028

Friday, October 10, 2014 11:57 AM

The overall pain market will maintain $38 billion in sales in 2028 across the major pharmaceutical markets (U.S., France, Germany, Italy, Spain, the U.K. and Japan), according to Burlington, Mass.-based Decision Resources Group.

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PhotoxAir reduces airborne bacteria in clinical trials

Thursday, October 9, 2014 11:54 AM

Wake Forest Baptist Medical Center, a North Carolina-based medical center, has announced that studies have conclusively demonstrated that the PhotoxAir purification system significantly reduced airborne bacteria in clinical trials conducted in an emergency department setting.

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Bristol-Myers Squibb withdraws NDA with FDA for asunaprevir

Thursday, October 9, 2014 11:51 AM

Given the rapidly evolving hepatitis C (HCV) treatment landscape in the U.S., Bristol-Myers Squibb has decided that it will not pursue FDA approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the U.S. and has therefore withdrawn its new drug application (NDA) for asunaprevir, an NS3/4A protease inhibitor. The company will continue to pursue FDA approval of daclatasvir, a potent, pan-genotypic NS5A complex inhibitor (in vitro), which currently is being investigated globally in multiple treatment regimens for HCV patients with high unmet need.

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Chimerix receives Emergency Investigational NDA for Ebola

Thursday, October 9, 2014 11:45 AM

Chimerix, a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, has announced that brincidofovir has been provided for potential use in patients with Ebola virus disease. These requests were made by treating physicians. Emergency Investigational New Drug Applications (EIND) were granted by the FDA.

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U.K. public believes not enough is being spent on medicines

Thursday, October 9, 2014 11:35 AM

A new survey has found more than half (52%) of English adults believe that not enough of the NHS budget is being spent on medicines. The survey was commissioned by the Association of the British Pharmaceutical Industry (ABPI), which includes research-based biopharmaceutical companies in the U.K.

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October 20

Toronto Star, with FDA data, exposes weaknesses in Health Canada's clinical trial, inspection oversight

Crowdsourcing effort aims to fund updated online social media guide for sponsor interaction with patients

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September

Today's fastest, most economical sponsors
Standout sponsors reveal how they shorten regulatory, clinical cycle times

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CW’s first site focus groups uncover frustration with 'progress,' but a passion for their mission

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August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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