DIA Biosimilars 2013

Articles Published in 2012

Almac concludes commercial API manufacturing facility expansion plans

Wednesday, October 10, 2012 10:14 AM

In response to client requirements, global service provider Almac’s expansion of their API manufacturing facility at its European headquarters in Craigavon, U.K. is near completion, and will be operational by the end of the year. 

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Cenduit: Now with Patient Reminders

Survey: U.S. adults trust Internet more than pharmacist on health care decisions

Wednesday, October 10, 2012 09:51 AM

A new RxAlly survey revealed that only 18% of U.S. adults trust a pharmacist most to help guide and inform healthcare decisions for themselves and their families. A majority of people trust their doctor most 72%, followed by friends and family 36%, spouses or significant others 36% and the Internet 22%.

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CRF Health – eCOA Forum

Theorem optimizes services for regulatory and clinical issues

Wednesday, October 10, 2012 09:22 AM

Theorem Clinical Research, a King of Prussia, Penn.-based full-service CRO that provides core clinical R&D services, also helps clients identify and strategically address early and ongoing device-related regulatory and clinical issues.

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Life Technologies acquires Compendia Bioscience

Tuesday, October 9, 2012 02:54 PM

Carlsbad, Calif.-based Life Technologies is acquiring Compendia Bioscience, a cancer bioinformatics company helping the pharmaceutical industry to identify novel gene targets for drug discovery and development.

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Noven initiates phase II study of investigational d-ATS for ADHD

Monday, October 8, 2012 08:00 AM

Noven Pharmaceuticals, a a specialty pharmaceutical company and wholly-owned subsidiary of Hisamitsu Pharmaceutical, has commenced a phase II study of a d-Amphetamine Transdermal System (d-ATS) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents.

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Takeda to acquire LigoCyte Pharmaceuticals

Friday, October 5, 2012 02:31 PM

Osaka, Japan-based Takeda Pharmaceutical’s wholly-owned subsidiary Takeda America Holdings will acquire LigoCyte Pharmaceuticals of Bozeman, Mont., for an upfront payment of $60 million, with future contingent consideration based on the progress of development projects.

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The Medicines Company discontinues phase IIb trial

Friday, October 5, 2012 02:27 PM

The Medicines Company has voluntarily discontinued its phase Iib, dose-ranging study of MDCO-2010, a serine protease inhibitor being developed to reduce blood loss during surgery. This action was taken in response to serious unexpected patient safety issues encountered during the trial, which so far had recruited 44 of a planned 90 patients in the first stage of the study.

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KaloBios files registration statement for proposed IPO

Friday, October 5, 2012 02:25 PM

South San Francisco-based KaloBios Pharmaceuticals has filed a registration statement with the Securities and Exchange Commission for a proposed initial public offering of its common stock. The number of shares to be offered and the price range for the offering have not yet been determined.

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BioSeek awarded new 5-year contract from EPA ToxCast program

Friday, October 5, 2012 08:00 AM

BioSeek, a drug discovery services company based in San Francisco, has been awarded a significant new contract extending and expanding the company's collaboration with the Environmental Protection Agency (EPA) under the EPA ToxCast screening program. 

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BioSante, ANI Pharmaceuticals ink merger

Friday, October 5, 2012 08:00 AM

Lincolnshire, Ill.-based BioSante Pharmaceuticals and ANI Pharmaceuticals, a fully integrated specialty branded and generic pharmaceutical company of Baudette, Minn., have entered into a definitive merger agreement through an all-stock transaction, with BioSante as the surviving company.

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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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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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