Cromos Pharma, where the patients are

Articles Published in 2011

Ezose Sciences partners with Merck to advance biomarker discovery in diabetes

Friday, December 9, 2011 08:35 AM

Ezose Sciences has entered an agreement with Merck, through a subsidiary, to collaborate on biomarker discovery research in the field of diabetes. The collaboration seeks to identify glycans, the complex carbohydrate component of glycoproteins, which can play a role in health and disease.

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CRF Health eCOA webinar series

Pearl Therapeutics' COPD trial shows positive results

Friday, December 9, 2011 08:17 AM

Pearl Therapeutics has reported positive top-line results from a randomized, double-blind, phase IIb, dose-ranging study of glycopyrrolate, a long-acting muscarinic agonist delivered twice a day via metered-dose inhaler in patients with moderate-to-severe COPD. Four doses of GP MDI were compared to placebo and Atrovent HFA Inhalation Aerosol, a short-acting muscarinic antagonist given four times a day. All doses of GP MDI tested produced statistically significant improvements in lung function compared to placebo. Further, doses of PT001 were identified that were non-inferior to Atrovent HFA. PT001 was well tolerated and no safety concerns were identified.

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Janssen, Pharmacyclics collaborate to develop anti-cancer drug

Friday, December 9, 2011 07:56 AM

Janssen Biotech, one of the Janssen Pharmaceutical companies of Johnson & Johnson, has executed an agreement with Pharmacyclics to jointly develop and market the anti-cancer compound, PCI-32765. A number of phase I and II studies with PCI-32765 are ongoing across a panel of B-cell malignancy disorders, including chronic lymphocytic leukemia, mantle cell lymphoma, and diffuse large B-cell lymphoma.

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Fang joins SRI as director of clinical manufacturing

Thursday, December 8, 2011 02:09 PM

Jia-Hwa Fang, Ph.D., has joined SRI's biosciences division as director of clinical manufacturing. In this new role, he will lead a team to transfer and scale-up R&D, Good Laboratory Practice (GLP), and pilot formulations for early stage clinical
trial materials in compliance with Good Manufacturing Practices (GMP). He will be responsible for developing technical, quality, and project specifications for studies in SRI's pharmaceutical clinical manufacturing facility.

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Neox to open first US office in San Diego

Thursday, December 8, 2011 01:26 PM

Neox Clinical Research, a European clinical research organization with headquarters in the Czech Republic, will be opening an office in San Diego, California in the first quarter of 2012 as their North American headquarters.

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Molecular Partners expands research collaboration with Janssen Biotech

Thursday, December 8, 2011 12:17 PM

Molecular Partners has entered into a strategic research collaboration and option agreement with Janssen Biotech to research, discover and develop DARPin products for the treatment of immunological diseases. The collaboration and expansion of its current agreement with the company and its affiliates aims to explore a defined set of targets, including the use of multispecific DARPins, to address diseases where continued unmet needs for effective treatment options continue to exist.

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Adams joins Auxilium Pharmaceuticals

Thursday, December 8, 2011 11:56 AM

Auxilium Pharmaceuticals has named Adrian Adams chief executive officer and president, effective immediately. Adams succeeds Armando Anido, who has agreed to step down as chief executive officer and president and has resigned as a member of the board of directors.

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Theratechnologies to discontinue COPD clinical program

Thursday, December 8, 2011 10:36 AM

Theratechnologies is discontinuing its muscle wasting in COPD clinical program, downsizing and accelerating its path to profitability. The company now aims to be profitable in 2013.

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PhRMA issues statement on biosimilar user fees

Thursday, December 8, 2011 10:20 AM

Pharmaceutical Research and Manufacturers of America (PhRMA) vice president Sascha Haverfield-Gross has issued the following statement about user fees for biosimilars:

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AstraZenca to cut 1,150 US sales positions

Wednesday, December 7, 2011 01:56 PM

AstraZeneca will reduce its U.S. sales force by approximately 1,150 leadership positions and sales representatives as part of the company’s ongoing strategy to operate its business more efficiently to best serve patients in the United States.

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April 14

Proposal calls for back-to-back trials to measure efficacy and effectiveness prior to FDA approval

Study: Minority populations under-represented in cancer trials, but have higher rates of incidence

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The CenterWatch Monthly

April

Make way for mobile health in clinical trials
Despite patient retention, data quality benefits, regulatory hurdles persist

Global clinical trial laboratories decentralize
Regional labs reducing complexity, delivering cost and time savings

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March

Strategic alliances hit bumps in the road
Mixed relationship performance driving new approaches

Tapping community hospitals for clinical trial volunteers
New study finds high potential but infrastructure, resources are lacking

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