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Items tagged with Drug-resistant TB

RESIST-TB newsletter (post)

RESIST-TB released its March newsletter. The presentation slides and recording of the webinar on the NiX-TB trial, conducted on 26 March 2020, are now available online.

EMA panel backs pretomanid for drug-resistant TB (post)

The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has recommended approval of pretomanid FGK (FGK Representative Service GmbH) for drug-resistant tuberculosis (TB).

WHO launches online course to improve diagnosis of drug-resistant TB (post)

WHO/Europe has launched a new online course to strengthen the capacity to diagnose drug-resistant tuberculosis (DR-TB) using molecular techniques. This free course, entitled “Drug-resistant tuberculosis: how to interpret rapid molecular test results”, is available on the OpenWHO platform and includes opportunities for participants throughout the world to seek expert advice for their diagnostic questions.

Challenges in TB regimen development: preserving evidentiary standards for regulatory decisions and policymaking (post)

"Ultimately, high-quality evidence to guide regulatory and policy decision-making must come from adequately designed (and funded) RCTs [randomized controlled trials]–the highest attainable standard of medical evidence, which we owe to patients affected by drug-resistant tuberculosis to strive for and maintain."

Korea upgrades guidelines for multidrug-resistant TB (post)

Korean patients with multidrug-resistant tuberculosis (TB) will likely get faster and better treatment than now.

Increased access to pretomanid/BPaL regimen (post)

27 May 2020, Geneva, Switzerland –  On 28 October 2019, the Stop TB Partnership announced the addition of pretomanid to the Global Drug Facility (GDF) catalog as part of a BPaL regimen containing bedaquiline, pretomanid, and linezolid. GDF supplies pretomanid to countries in accordance with WHO recommendations for people with extensively drug-resistant TB (XDR-TB) when used under operational research conditions.

Deltyba® (delamanid) approved in the Russian Federation for the treatment of pulmonary MDR-TB (post)

-- Deltyba® (delamanid) — an essential medicine according to the World Health Organization [1] — is now available in Russia for difficult-to-treat MDR-TB patients.
-- Deltyba® (delamanid), developed by Otsuka Pharmaceutical Co., Ltd. based in Japan, is commercialized in Russia by the R-Pharm group of companies.

U.S. FDA approves new pediatric formulation of SIRTURO® (bedaquiline) as part of combination therapy to treat children with pulmonary multidrug-resistant TB (post)

NEW BRUNSWICK, NJ, May 27, 2020 — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has granted approval for a new pediatric formulation of SIRTURO® (bedaquiline). SIRTURO® is now indicated for use as part of combination therapy in the treatment of adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary multidrug-resistant tuberculosis (MDR‑TB). In the U.S., the medicine should be reserved for use when an effective treatment regimen cannot otherwise be provided.

RESIST-TB newsletter (post)

RESIST-TB released its May 2020 newsletter with the latest research publications on drug-resistant TB.

Drug-resistant TB is often similar among household members (post)

The resistance profiles of patients with drug-resistant tuberculosis may be useful in developing treatment plans for household contacts, according to a new study that examined the concordance of drug resistance profiles among household members.

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