Welcome to the Working Group on New TB Drugs Blog
Bedaquiline Receives Accelerated Approval from the FDA for MDR-TB Rx
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.
FDA Advisory Committee recommends Janssen’s Bedaquiline for accelerated approval
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.
TB R&D Weekly Update: Janssen Seeks Approval from FDA for Bedaquiline
This week it was announced the Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, filed a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for their drug Bedaquiline (a.k.a. TMC-207).
World TB Day Coverage: New Combo TB Drug Trial Announced
During the “Cure All: A briefing on the status of the most promising new TB drugs research” sponsored by the Critical Path to New TB Drug Regimens (CPTR) on Monday, March 19, Dr. Mel Spigelman, CEO & President, of TB Alliance announced the launch of the NC002 trial, a combination drug trial that establishes a new pathway to TB and multi-drug resistant TB treatment. The meeting also involved high-level officials from U.S. agencies that support TB research including Anthony Fauci (Director, NIAID/NIH), Janet Woodcock (Director, CDER/FDA), and Robert Clay (Deputy Assistant Administrator, Global Health Bureau/USAID).
TB R&D Weekly Update: PA-824 Exhibits Time-Dependent Activity in Mice
This week’s TB R&D update presents a summary of the article “PA-824 exhibits time-dependent activity in a murine model of tuberculosis” published in the AAC January issue. Also, links to notable news articles relevant to TB R&D are included.
FDA Streamlines Review for Drug Combinations
The FDA issued a draft guidance for the drug industry entitled “Guidance for Industry Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination.”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.
FDA Awards Nearly $3 Million for TB Research
The U.S. Food and Drug Administration (FDA) announced $2.9 million to support six research projects related to the diagnosis, treatment and prevention of tuberculosis on Monday. This investment is a component of the FDA’s Critical Path Initiative (CPI) — a national strategy for transforming the way FDA-regulated products are developed, evaluated and manufactured.
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Toppix TB News- TB, a neglected disease in Uganda 15 May 2013
- Dr. John: Medications, T.B, tinnitus 8 May 2013
- U.S. non-profit group to build tuberculosis center in Pyongyang 4 May 2013
- Predictors of tuberculosis (TB) and antiretroviral (ARV) medication... 26 Apr 2013
- Multidrug-resistant tuberculosis (MDR-TB): an interview with Dr.... 26 Apr 2013
