Technology Solutions

FDA, Emulate partner on organs-on-chips technology

Wednesday, April 12, 2017

Emulate has entered into a Cooperative Research and Development Agreement (CRADA) with the FDA’s Office of Foods and Veterinary Medicine. Under this multi-year CRADA, Emulate and FDA will collaborate to evaluate and qualify the use of Emulate’s Organs-on-Chips technology as a platform for toxicology testing to meet regulatory evaluation criteria for products—including foods, dietary supplements and cosmetics. The CRADA studies will use Emulate’s Human Emulation System, comprised of Organ-Chips, instrumentation and software apps. The system recreates the natural physiology of specific human tissues and organs, and is designed to provide a predictive model of human response to diseases, medicines, chemicals, and foods with greater precision and detail than other preclinical testing methods, such as cell culture or animal-based experimental testing.

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Novo Nordisk launches HemaGo XChange Portal for hemophilia patients

Wednesday, April 12, 2017

Novo Nordisk announced the availability of HemaGo XChange, a web-based portal that allows people with hemophilia to connect their circle of care to their treatment and bleed information, promoting collaboration and discussion regarding the management of their bleeding disorder. HemaGo XChange enhances the offerings of Novo Nordisk’s HemaGo mobile application and website, which since 2012 has helped patients track their hemophilia treatment, bleeding episodes and life events.

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Sartorius acquires Umetrics, closes acquisition of Essen BioScience

Tuesday, April 11, 2017

Sartorius, an international partner of the biopharmaceutical industry and research laboratories, acquired through its subgroup Sartorius Stedim Biotech the company MKS Instruments (Umetrics) based in Malmö, Sweden. Umetrics is a specialist in data analytics software for modeling and optimizing biopharmaceutical development and manufacturing processes. Umetrics has already been cooperating with Sartorius for around five years and, in 2017, plans to generate full-year sales revenue of around U.S. $15 million and a significant double-digit operating profit margin. Sartorius purchased the company for U.S. $72.5 million from the U.S. MKS Instruments Group.

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Report: More drug innovation necessary for mental health

Friday, April 7, 2017

As the healthcare industry looks to make good on a promise of patient-centricity, advocacy groups and regulators have increased their focus on earlier patient involvement in clinical trials, with particular attention on so-called patient-reported outcome (PRO) measures. However, according to new research looking at payer perspectives on mental health, use of PROs that track patients’ wishes and experiences in their own voices, unamended by clinicians, may not help manufacturers make a more persuasive case about a new drug when talking to insurers. The research, released by inVentiv Health, found that 92% of private payers do not wish to see wider use of such measures in clinical trials.

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