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.
The results of the first TB vaccine efficacy trial in over 90 years was released today showing that the vaccine candidate MVA85A when given as a booster did not provide added protection to infants who had already received BCG. The trial adds scientific value to the field and enhances the field’s understanding and ability in conducting large-scale TB vaccine trials. Additional links to TB R&D news are included.
The week of November 12th was exciting with the 43rd Union World Conference, the WGND Annual Meeting (will be posting presentations soon), and the Stop TB Coordinating Board Meeting. Included are some news highlights and a listing of webcasts of interesting and presentations relevant for TB drug development and research.
This week we highlight an interview with Dr. Andrew Vernon, the Chief, Clinical Research Branch, Division of Tuberculosis Elimination at the U.S. Centers for Disease Control and Prevention (CDC). He discusses the progress made in TB drug development and the growing number of TB trials and trials groups.