DIA Biosimilars 2013

Articles Published in 2013

CFS Clinical named one of best places to work

Wednesday, August 7, 2013 11:57 AM

Philadelphia Business Journal has named CFS Clinical, a specialty provider focused on the business and financial management activities for clinical trials, one of its Best Places to Work in the Philadelphia region for the second year in a row. The award recognizes the company’s achievements in creating a positive work environment that attracts and retains employees through a combination of benefits, working conditions and company culture.

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Cenduit: Now with Patient Reminders

The Medicines Company completes Profibrix acquisition on positive trial results

Wednesday, August 7, 2013 11:53 AM

The Medicines Company announced the results of a phase III clinical trial of ProFibrix's lead biologic, Fibrocaps, and, based on its review of those results, completed its previously announced purchase of the company.

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CRF Health – eCOA Forum

Ensemble Therapeutics, Novartis collaborate

Wednesday, August 7, 2013 11:51 AM

Ensemble Therapeutics, a biotechnology company developing Ensemblins, a novel class of small molecule therapeutics with the power of biologics, has initiated a two-part R&D collaboration with Novartis. The companies have entered into a strategic development agreement for Ensemble's most advanced proprietary program that targets the inflammatory cytokine IL-17, and for a new program to discover novel small molecule treatments against undisclosed drug targets specified by Novartis using Ensemble's proprietary drug discovery platforms.

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Industry associations support FDA Safety Over Sequestration Act

Wednesday, August 7, 2013 11:45 AM

Senator Mark Pryor, chairman of the Senate Appropriations Subcommittee on Agriculture, Rural Development, FDA and Related Agencies, and Sens. Roy Blunt, Daniel Coats, Al Franken and Jerry Moran last week introduced S. 1413 to exempt future FDA user fees from sequestration. A similar bill, H.R. 2725, was introduced in the U.S. House of Representatives earlier this month by Representatives Leonard Lance, Anna Eshoo, Mike Rogers and Doris Matsui.

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Oncobiologics, inVentiv Health partner for biosimilars

Wednesday, August 7, 2013 11:43 AM

Privately-held biopharmaceutical company Oncobiologics and inVentiv Health have partnered around clinical development for all assets in Oncobiologic's pipeline. The global partnership will initially focus on biosimilar assets, and could be expanded to include innovative molecules.

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Komtur Pharmaceuticals forms joint venture with HenHeKangJain China

Wednesday, August 7, 2013 11:38 AM

Komtur Pharmaceuticals, a German specialist in clinical trial sourcing, is investing in Chinese HengHeKangJian Pharmaceutical Trading. The joint venture company will operate under Komtur-Solin Pharmaceuticals.

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NuMe Health becomes MicroBiome Therapeutics

Wednesday, August 7, 2013 11:36 AM

NuMe Health has changed its name to MicroBiome Therapeutics and has hired Steve Orndorff, Ph.D., as chief executive officer.

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Icon forms collaboration in Taiwan

Wednesday, August 7, 2013 11:33 AM

Global CRO Icon and the National Clinical Trials and Research Center (NCTRC) at the National Taiwan University Hospital, have formed a collaboration agreement to enhance the setup and management of clinical studies in Taiwan.

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TransCelerate BioPharma’s Clinical Trial Comparator Network now active

Wednesday, August 7, 2013 11:26 AM

TransCelerate BioPharma has reached its primary milestone in its Clinical Trial Comparator Network initiative. Formed to establish reliable, rapid sourcing of quality drug products for use in clinical trials, the Comparator Network will enable accelerated clinical trial timelines and enhanced patient safety.

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S1 Biopharma doses first patients in phase IIa trial of Lorexys

Tuesday, August 6, 2013 12:30 PM

S1 Biopharma, a developer of first-in-class drugs for sexual dysfunction in women and men, has announced enrollment and dosing of premenopausal women with hypoactive sexual desire disorder (HSDD) in the phase IIa clinical trial of its leading drug candidate Lorexys (S1P-104).

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September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

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The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

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The CenterWatch Monthly

September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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