News about 'Regulations and Guidelines'

The European Commission has approved Delaminid (Deltyba™) for use in patients suffering from MDR-TB. Delamanid was developed by Otsuka Pharmaceutical Co., Ltd., a Japanese pharmaceutical company dedicated to drug discovery for tuberculosis. The press release from Otsuka can be found here Related...

The European Medicines Agency (EMA) has recently approved Sirturo (bedaquiline) for conditional use in the European Union for adults suffering from pulmonary MDR-TB. The press release from Multimedia News Release can be found at: http://www.multivu.com/mnr/65014-sirturo-treatment-multi-drug-...

From the Stop TB Parntership News: The World Health Organization (WHO) has issued interim guidance on the use of bedaquiline, a new tuberculosis drug, for the treatment of multidrug-resistant tuberculosis (MDR-TB). Bedaquiline was granted accelerated approval by the United States Food and Drug...

Press Release from FDA can be found at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm333695.htm . Press Release from Janssen is below. FDA Grants Accelerated Approval for SIRTURO™ (bedaquiline) as Part of Combination Therapy to Treat Adults with Pulmonary Multi-Drug Resistant...

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. You can access materials from the meeting at http://www.fda.gov/AdvisoryCommittees/Calendar/ucm321011.htm . The sponsor and...

Click here to read the full document. Launch of the Good Participatory Practice Guidelines for TB Drug Trials 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...

The WHO issued updated guidelines on the programmatic management of drug-resistant TB on August 4, 2011 online in the European Respiratory Journal . Abstract The production of guidelines for the management of drug-resistant tuberculosis fits the mandate of the World Health Organization (WHO) to...

Monedero I, Caminero JA. Evidence for promoting fixed-dose combination drugs in tuberculosis treatment and control: a review. Int J Tuberc Lung Dis. 2011 Apr;15(4):433-9. In this week’s article, Monedero and Caminero conduct a critical review of research on the use of fixed-dosed combinations (FDCs...

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...

The Wall Street Journal Health Blog reported that the FDA issued a draft guidance for the drug industry “designed to encourage companies to work in tandem to develop two or more new drugs to be used in combination to treat cancer and infectious diseases, among other illnesses.” This is exciting...