The FDA granted Janssen’s TB drug Bedaquiline accelerated approval for treatment of MDR-TB. A link is provided to the FDA press release and Janssen’s full press release is included.
Yesterday, Nov. 28th, the FDA Ant-infective Drug Advisory Committee voted to recommend Janssen’s Bedaquiline for accelerated approval for the treatment of MDR tuberculosis. A summary of the proceedings is included.
The Stakeholder and Community Engagement Workgroup of the Critical Path to TB Drug Regimens initiative launches guidelines that will facilitate the involvement of communities and participants in the conduct of TB drug trials.
The WHO issued updated guidelines on the programmatic management of drug-resistant TB on August 4, 2011 online in the European Respiratory Journal.
In this week’s article, Monedero and Caminero conduct a critical review of research on the use of fixed-dosed combinations (FDCs) for tuberculosis with the conclusion that FDCs should continue to be promoted and recommended. Additional links to TB R&D News are included.
The Médecins Sans Frontières and The Union will release on World TB Day a new report entitled “DR-TB drugs under the microscope” outlining drugs currently available to treat drug-resistant tuberculosis (DR-TB) including product information, sources of the drug, quality status, and price.
The FDA issued a draft guidance for the drug industry entitled “Guidance for Industry Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination.” This is exciting news for TB drug development, since there is the potential to reduce the time to develop and obtain approval for new regimens by several years. The FDA is accepting comments from the public until February 14, 2011.