DIA Biosimilars 2013

Articles Published in 2013

Activaero, Chiesi collaborate for cystic fibrosis drug device combination product

Monday, September 9, 2013 12:03 PM

Activaero, focusing on novel, pharmacoeconomically meaningful treatment solutions for severe lung diseases, has entered a research collaboration with Chiesi Farmaceutici.

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Cenduit: Now with Patient Reminders

CellCentric selects Sygnature Discovery for epigenetic prostate cancer program

Monday, September 9, 2013 12:01 PM

Sygnature Discovery, a provider of integrated drug discovery services, has been selected by CellCentric, a biotechnology company with a scientific foundation in epigenetics, to progress small molecule inhibitor drug discovery against a specific deubiquitinase (DUB) enzyme which has been demonstrated to play a key role in the progression of prostate cancer.

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CRF Health – eCOA Forum

Oncodesign, Banook Central Imaging partner in pharmaco-imaging

Monday, September 9, 2013 12:00 PM

Oncodesign,a CRO  specializing in discovery of new anticancer therapies, and Banook Central Imaging, specializing in the centralized reading of medical images, have partnered to expand the use of new approaches in pharmaco-imaging.

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Eisai, Clinigen partner on patient access program in Germany

Monday, September 9, 2013 11:56 AM

Eisai EMEA, an R&D based pharmaceutical company, has established a named patient access program to ensure patients continue to receive an uninterrupted supply of the anti-epilepsy drug Fycompa (perampanel), following the temporary suspension of commercial distribution in Germany. The access program will be managed by Clinigen Global Access Programs (GAP), a U.K.-headquartered specialty global pharmaceutical company.

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MicroConstants China in-licenses liver cancer drug from Pertinax Therapeutics

Monday, September 9, 2013 11:54 AM

Site management organization and CRO MicroConstants China will in-license the China rights for a phase II liver cancer drug, PTX-9908, from Pertinax Therapeutics of Canada. MicroConstants China will be responsible for funding clinical development of PTX-9908 in China. Pertinax will receive a royalty in connection with sales, as well as any future assignment or transfer of the rights.

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Enzymatics acquires ArcherDx and Next-Generation Diagnostic Technology

Friday, September 6, 2013 03:14 PM

Enzymatics, a producer of reagents, kits and assays, has acquired Boulder Colo.-based ArcherDx, a developer of NGS-based kits and software solutions for use in investigating cancer treatment. The deal consists of cash, equity and potential milestones worth up to $50 million.

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HeartWare receives FDA approval to enroll supplemental patient cohort

Friday, September 6, 2013 03:12 PM

The FDA has approved an IDE Supplement for HeartWare International, an innovator of less invasive, miniaturized circulatory support technologies for the treatment of advanced heart failure, to commence enrollment in an additional patient cohort for ENDURANCE, the company's Destination Therapy clinical study.

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Arena Pharmaceuticals completes phase Ib clinical trial

Friday, September 6, 2013 03:12 PM

Arena Pharmaceuticals has completed a phase Ib clinical trial for APD811, an investigational oral prostacyclin (IP) receptor agonist intended for the treatment of pulmonary arterial hypertension (PAH). The company plans to initiate a phase II clinical trial for APD811 in the first quarter of 2014.

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Michael Seiden named CMO for McKesson Specialty Health, U.S. Oncology Network

Friday, September 6, 2013 03:09 PM

McKesson Specialty Health and The U.S. Oncology Networkhave appointed of Michael V. Seiden, M.D., Ph.D. as chief medical officer.

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Michael J. Fox Foundation hosts first Clinical Trials Fair in Chicago

Friday, September 6, 2013 03:06 PM

The Michael J. Fox Foundation for Parkinson's Research (MJFF) will host its first Clinical Trials Fair in Chicago Sept. 7 to raise awareness and understanding of local Parkinson's research opportunities among patients, their families and friends and other volunteers.

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CWWeekly

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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