Certara expands PBPK simulator availability
Certara has developed a new licensing approach, which provides smaller organizations access to its physiologically-based pharmacokinetic (PBPK) modeling and simulation platform.
Archives for March 9, 2017
Apotex expanding US footprint with $184m investment
Generics maker Apotex will construct a manufacturing and packaging facility as part of a $184m US expansion.
SGS to operate Ph I inpatient clinical trials at Budapest hospital
SGS has signed a partnership agreement under which it will operate a dedicated clinical pharmacology unit for conducting Ph I inpatient clinical trials in Budapest, Hungary.
CRO insourcing to gain momentum, says NovAliX
NovAliX has signed an insourcing agreement with UCB Biopharma, a model that the CRO says “energizes scientific organization” and offers "significant" cost advantages.
Re-inspection lands Dr Reddy’s Form 483 with 13 observations at Duvvada plant
Dr Reddy’s Laboratories says it is addressing the observations at its Duvvada plant which was hit with a warning letter in 2015.
Nicox resubmits AC-170 NDA after API supplier resolves GMP issues
Nicox S.A. has resubmitted AC-170, its conjunctivitis associated itching drug candidate, for US FDA review after its API supplier resolved the problems that saw the agency reject the New Drug Application (NDA) last year.