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Kinesis submits eCTD-IND for new combination product to FDA .
Kinesis has submitted an IND for a fixed dose combination product to the FDA. The submission consisted of information on the separate compounds, as well as information on the combination product. Part of the nonclinical and clinical studies on the combination product were entirely coordinated by the Kinesis team. For one of the compounds, a full nonclinical and clinical package based on studies, literature and postmarketing experience have been included to document the known safety profile of the compound. The IND has entirely been submitted in eCTD format.
- 23/05/2012 - 2nd Annual Course on Drug Development in Seoul, Korea, May 23-24 2012
- 02/04/2012 - Endorsement of complicance to the OECD GLP guidelines for NCDSER/Innostar, China
- 19/03/2012 - Kinesis visits Wecome Medicine Industry, China
- 28/02/2012 - Kinesis Pharma supports two more Chinese labs to become OECD GLP compliant
- 30/01/2012 - Kinesis consultants registered as pharmaceutical medicine specialists at the NVFG.
- 16/01/2012 - Kinesis Pharma will prepare a paediatric investigational plan for a compound for treatment of an orphan disease.
- 28/10/2011 - Successful course on registration of traditional herbal medicinal products in EU for a Chinese company
- 10/10/2011 - New assignments in China
- 10/10/2011 - Phase III protocol receives FDA approval based on submission and data generated by Kinesis
- 28/09/2011 - Kees Bol, CEO Kinesis Pharma Singapore, Invited Speaker at BIO KOREA, 28-30 September 2011
- 26/09/2011 - New endorsement of compliance from the Dutch GLP Inspectorate
- 08/09/2011 - Kees Groen speaker at Expert Workshop (NMC & NBIC in co-creation with LURIS), September 8th 2011
- 02/09/2011 - CSForum "Innovative Technology" at Kinesis Pharma B.V.
- 01/09/2011 - New personnel from September 1st 2011!
- 04/08/2011 - Kees Bol (CEO Kinesis Pharma Singapore) speaker at seminar Exploit Technologies, Singapore
- 21/06/2011 - Kinesis Pharma trains Korean Pharm & Biotech Industries (KDRA)
- 13/06/2011 - Announcement R&D Training to Korean Pharm & Biotech Industries, KDRA, Seoul, Korea, 13-15 June 2011
- 26/05/2011 - Kinesis Pharma Singapore in online e-journal of PACRA
- 23/05/2011 - MicroConstants Beijing obtains OECD GLP accreditation for bioanalytical services.
- 01/05/2011 - Mike Ugwoke, Ph.D. starts as Senior Consultant CMC
- 01/12/2010 - Mymetics HIV Vaccine Shows Strong Preliminary Phase I Data
- 25/10/2010 - Successful Kinesis Pharma Seminar on October 8th 2010
- 06/10/2010 - Kinesis submits eCTD-IND for new combination product to FDA .
- 06/10/2010 - Kinesis Pharma and the Medicines for Children Research Network (MCRN)
- 06/10/2010 - Kinesis presents poster at 6th Int. Symposium on Measurement and Kinetics of In Vivo Drug Effects
- 01/09/2010 - Press Release: Kinesis Pharma BV (Kinesis) appoints new Chief Operating and Scientific Officer
- 01/08/2010 - Kinesis Pharma opens office in Singapore
- 26/06/2010 - Sino-Foreign Giants: Globalization is a trend in the biomedical industry in China
- 24/06/2010 - Westernization of Chinese pharmaceuticals, but do not forget Traditional Chinese Medicine (TCM)