2016

Harbour BioMed acquires Harbour Biomed Antibodies, plans to expand

Tuesday, December 20, 2016

Harbour BioMed, a recently established Shanghai-based company, has acquired Harbour Antibodies for cash and an equity interest in Harbour BioMed to create a new, global oncology-focused biotechnology company. The new company plans to leverage Harbour Antibodies’ patented transgenic mouse platforms to build an internal portfolio of next generation therapeutic antibodies for cancer, expand the range of partnerships and licenses around Harbour’s platforms, and capitalize on the Harbour BioMed management team’s extensive worldwide drug discovery and development expertise.

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EMA to offer advice for new biosimilars

Tuesday, December 20, 2016

The EMA will launch a pilot project in February 2017 to test the added value and feasibility of tailored scientific advice for the development path of biosimilar medicines. Through this new initiative, EMA aims to provide developers of biosimilars with advice on the studies/tests they should be conducting, on the basis of the quality, analytical and functional data they have already available for the medicine.

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Janssen Biotech submits stelara approval application for plaque psoriasis

Monday, December 19, 2016

Janssen Biotech announced the submission of a Supplemental Biologics License Application (sBLA) to the FDA seeking approval of STELARA (ustekinumab) for the treatment of adolescents (12 to 17 years of age) with moderate to severe plaque psoriasis. It is estimated that 7.5 million Americans have psoriasis, which can range from mild to severe and disabling, and approximately one-third of those affected develop the immune-mediated disease before 20 years of age.2 STELARA, a human monoclonal antibody that targets interleukin (IL)-12 and IL-23 cytokines, has been approved in the United States for the treatment of adults with moderate to severe plaque psoriasis since September 2009.

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An exciting year for the medical technology industry

Monday, December 19, 2016

The Pulse on Global Trials by Matthew Howes

In the medical technology industry, 2016 has been an exciting year for R&D. From the development of naturally moving prosthetic limbs that are controlled by the brain to the use of a needle-free vaccine delivery device in Zika trials, medical devices are becoming a major focus in the advancement of human health.

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