Results of the Phase III REMoxTB clinical trial were published in the New England Journal of Medicine on September 7th, 2014. REMox or Rapid Evaluation of Moxifloxacin in Tuberculosis (REMoxTB) was a trial designed to determine whether replacement of either ethambutol or isoniazid with moxifloxacin shortened the duration of therapy. In summary, while the regimens with moxifloxacin caused a [...]
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) failed to recommend marketing approval for delamanid, a new drug in development for multidrug-resistant tuberculosis (MDR-TB). A letter from the Treatment Action Group criticizing this decision is included.
Enrollment has begun for a ground-breaking clinical program exploring the use of delamanid in paediatric multidrug-resistant tuberculosis (MDR-TB). Otsuka is the first company to perform a trial among this population for regulatory approval. The programme will also evaluate the bioequivalence of a dispersible formulation for use with younger children and infants.
HIV i-Base and Treatment Action Group (TAG) called on global and national leaders, research sponsors, and regulatory authorities to work together to make the best HIV, HCV, and TB drugs, diagnostics, and vaccines accessible as fast as possible, according to a report released today at the 7th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention in Kuala Lumpur, Malaysia.