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TranScrip Applauds Landmarks in the Battle for New Antibiotics


7/9/2012 9:33:30 AM

LONDON--(BUSINESS WIRE)--TranScrip, the leading contract organisation that supports clinical and regulatory product development, believes the last seven days are a landmark period in Europe and the US for stimulating badly needed new antibiotic drug development. Europe spearheaded the original guidance to size antibiotics trials not on equivalence, but on non-inferiority. This has now been widely adopted in many therapeutic areas as well as on both sides of the Atlantic. The latest Innovative Medicines Initiative (IMI) project seeks to take the lead in antibiotic trial design in Europe once again as well as pumping some $285m into the more practical aspects of antibiotic research and development. 7th of July 2012 saw the closing date for Expression of Interest for the IMI 6th Call New Drugs 4 Bad Bugs (ND4BB). IMI is a unique organisation stimulating public-private partnership with big pharmaceutical companies, SMEs and academia. The ND4BB initiative is in direct response to the urgent need to stay ahead of the battle against antibiotic resistance. It is hoped that together with the far reaching proposals in the way in which trials are designed and conducted, the ND4BB project will be as innovative as the successful introduction of non-inferiority analyses.

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