Mylan Gets Expert Panel Go-Ahead For Pretomanid In India
Tuberculosis drug pretomanid gets endorsement, with Phase III trial waiver, from a key expert panel that advises India's drugs regulator, but roll out plan needs to be defined under the country’s national TB program, say health activists.
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While Viatris says it has sufficient capacity to meet current and future demand for tuberculosis drug pretomanid, TB Alliance has signed a non-exclusive license with Lupin. This is the second tie-up with an Indian manufacturer but the local restricted use approval means countries other than India are likely to benefit for now.
South Korea’s Qurient achieves proof of concept in a Phase II study with its first-in-class antibiotic telacebec for tuberculosis and aims to file a US NDA for the orphan drug.
Price cuts, new treatments for TB and alliances to improve access to these medicines were among the key talking points at the recently concluded Union World Conference on Lung Health in India. TB survivors and activists were also vocal and pressed hard for their demands to be heard.