Tags : TB Alliance

PharmaShots Weekly Snapshot (January 20-24, 2020)

1. Epizyme’s Tazverik (tazemetostat) Receives the US FDA’s Accelerated Approval as the First Therapy for Epithelioid Sarcoma Published: Jan 23, 2020 | Tags: Epizyme, Tazverik, tazemetostat, Receives, US, FDA, Accelerated Approval, First Therapy, Epithelioid Sarcoma 2. Evarsana Signs an Agreement with Evoke Pharma to Commercialize Gimoti in the US Published: Jan 23, 2020 | Tags: Evarsana, Signs, […]Read More

TB Alliance Collaborates with Hongqi Pharma to Commercialize New Therapy

Shots: Hongqi to get a license to commercialize pretomanid as part of the three-drug “BPaL” regimen to treat a highly drug-resistant form of tuberculosis in People’s Republic of China The collaboration is a part of TB Alliance’s global commercialization strategy for pretomanid, complementing its previous agreement with Mylan & Macleods to commercialize pretomanid as part […]Read More

Insights+: The US FDA New Drug Approvals in August 2019

The US FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 31 new products so far in 2019. In 2018 FDA approved 59 novel products including 42 New Chemical Entity and 17 Biologics while breaking its past year’s records of approval. However, there is a significant […]Read More

TB Alliance’s Pretomanid Combination Therapy Receives the US FDA’s Approval

Shots: The approval is based on the Nix-TB trial assessing bedaquiline, pretomanid and linezolid collectively called BPaL regimen in 109 patients with XDR-TB treatment-intolerant or non-responsive MDR-TB across three sites in South Africa The study demonstrated successful outcomes in @6mos. 95/107 patients and for two of the patients the study was extended to nine months. […]Read More

Mylan and TB Alliance Collaborate to Commercialize Pretomanid in Two

Shots: Mylan to get manufacturing & commercialization rights of pretomanid in BPaL regimen (bedaquiline, pretomanid and linezolid for 6-9 mos.) for XDR & MDR-TB. Janssen to hold the rights for bedaquiline (Ex- DS-TB) and linezolid is available from multiple manufacturers, including Mylan TB Alliances has also licensed Pretomanid to Mylan for DS & MDR-TB and […]Read More