There are many risks involved with opening pharmaceutical manufacturing operations in Asia, but Signapore has become ideal for the Life Sciences industry.
More and more drug companies are finding it financially advantageous to conduct clinical trials in foreign countries and to include data from these trials in NDA submissions. When offshore trials are properly conducted and the data is properly handled, this strategy can accelerate approval and lower the cost of drug development. By Ken Phelps, Camargo Pharmaceutical Services
Every biopharmaceutical company today is striving to arrive at the Proof-of-Concept decision point for new treatments as quickly and cheaply as possible. Management is looking to identify potential winners and avoid costly late stage failures. By Sy Pretorius, Corporate Vice President and World-wide Head of Early Phase, PAREXEL International Corporation
For industry committed to delivering innovative healthcare, now is the time to take stock of the shift in population demographics and how cultural competence relates to developing new medicines through clinical trials. By James Gillespie and Kathleen Drennan
Clinilabs, a contract research organization (CRO), was selected to characterize the pharmacokinetic prole of XXXX following the administration of four doses of XXXX to healthy Japanese and non-Japanese subjects aged 20 to 45 years by assessing serum concentration data over time.
Agile Therapeutics presented findings from a phase III pivotal trial of AG200-15, Agile's investigational once-weekly combination contraceptive patch containing ethinyl estradiol (EE) in combination with levonorgestrel (LNG).
Abbott (NYSE: ABT) and Enanta Pharmaceuticals announced complete data from the study known as "Pilot" – Abbott's initial interferon-free study of its direct-acting antiviral agents for the treatment of hepatitis C (HCV) – showing that 91 percent of genotype 1 infected, treatment-naive patients taking ABT-450/r and ABT-072 combined with ribavirin administered for 12 weeks, achieved sustained viral response at 24 weeks (SVR24).
Abbott (NYSE: ABT) will present clinical trial results from two different interferon-free, Phase 2 studies for the treatment of hepatitis C (HCV) at the International Liver Congress™ 2012 (ILC 2012), the annual meeting of the European Association for the Study of the Liver (EASL), April 18-22 in Barcelona, Spain.