FDA Approves New Treatment for Adult Patients With Rare, Life-Threatening Blood Disease (PNH)

Posted by Tracy Hendershott on Dec 24, 2018 9:00:00 AM

At Eurofins BioPharma Services, we feel this FDA press release, as a Christmas gift that came early! After working on multiple protocols, across multiple clients, we couldn't be happier to see the continued evolution of treatment solutions for this rare disease (around 2 cases per million). Prior to the first treatment being released in 2007, life expectancy of patient diagnosed with PNH was only ten years, with poor quality of life throughout that time. With the significant resource dedication of years of effort and capital, our peers and colleagues throughout the clinical trial industry have allowed patients to have:

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Tags: FDA, Central Laboratory, Clinical Trial, PNH, New Treatment

FDA Guidance: Testicular Toxicity

Posted by Tracy Hendershott on Nov 26, 2018 9:29:00 AM

 

Testicular Toxicity

After being in the draft stages for approximately three years and continuing to receive industry feedback, the FDA CDER has just released final Guidance for Industry Title Testicular Toxicity: Evaluation During Drug Development in October 2018. There are numerous challenges with conducting multi-center clinical trials focusing on testicular toxicity and yet remaining within the realm of guidance from the FDA per their statement:

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Tags: FDA, Central Laboratory, Testicular Toxicity, Clinical Trial

World COPD Day

Posted by Tracy Hendershott on Nov 21, 2018 9:00:00 AM

World Chronic Obstructive Pulmonary Disease (COPD) Day is organized by the Gloobal Initiative for Chronic Obstructive Lung Disease (GOLD) in collaboration with health care professionals and COPD patient groups throughout the world. World COPD Day is celebrated on November 15th, 2018, and it's aim is to raise awareness about the disease and improve outcomes throughout the world.

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Tags: Central Laboratory, Clinical Trial, Drug Development

World Prematurity Day

Posted by Tracy Hendershott on Nov 16, 2018 9:00:00 AM

On November 17th, 2018, we celebrate World Prematurity Day with March of Dimes. According to March of Dimes, "Premature birth is the leading cause of death in children under the age of five worldwide. Babies born too early may have more health issues than babies born on time, and may face long-term health problems that affect the brain, the lungs, hearing or vision."

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Tags: Central Laboratory, Prematurity, BioPharma

World Diabetes Day

Posted by Tracy Hendershott on Nov 14, 2018 9:00:00 AM

On November 14th, 2018, we celebrate World Diabetes Day (WDD) in remembrance of Sir Frederick Banting, who co-discovered insulin, along with Charles Best in 1922. According to the International Diabetes Federation (IDF), World Diabetes Day was created in 1991 IDF and the World Health Organization in response to increasing concerns about the escalating health threat posed by diabetes to a growing number of people. 

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Tags: Central Laboratory, Clinical Trial, Diabetes

World Quality Day

Posted by Tracy Hendershott on Nov 8, 2018 3:00:00 PM

On Thursday, November 8th, 2018, we celebrate World Quality Day. This day was designed to increase worldwide awareness of the important contribution that quality makes toward both organizational and national growth as well as prosperity.

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Tags: Central Laboratory, Quality, Results, Clinical Trial