Hope For Price Flexibility After India Pretomanid Go-Ahead
Mylan gets approval in India for pretomanid as part of a combination regimen with bedaquiline and linezolid, providing new hope to patients with drug-resistant tuberculosis. Volume changes may provide opportunities to tweak prices.
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Lupin and non-profit organization TB Alliance have entered into a partnership for a new therapy for highly drug-resistant tuberculosis, pretomanid, to be distributed in 140 countries and territories.
TB Alliance CEO Mel Spigelman discusses a range of new and evolving aspects pertaining to the three-drug BPaL regimen for highly drug-resistant TB, including the ZeNix trial results and adding a licensee for pretomanid. He also notes how COVID-19 has had a “terrible impact” on efforts to tackle the TB pandemic.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include eight new products, including Roche's Rozlytrek (entrectinib) for the histology-independent indication of treatment of patients with NTRK fusion-positive solid tumors, and for treating patients with ROS1-positive advanced non-small cell lung cancer. The list, which contains information dating back to January 2018, comprises brand name, generic name, company, therapeutic indication, date of marketing authorization announcement and product type (eg, medicine, vaccine, biologic).