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Salix Files Crofelemer NDA As Napo Seeks To Terminate Their Collaboration

This article was originally published in The Pink Sheet Daily

Executive Summary

Salix submitted an NDA for HIV-associated diarrhea; it has exclusive rights to market the drug for that indication under a collaboration agreement with Napo but Napo claims Salix has breached the deal by delaying development and commercialization.

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Napo Pharmaceuticals Inc.

Napo Pharmaceuticals Inc. is developing its lead product crofelemer--a refined version of a natural extract from a South American tree-as a treatment for treating irritable bowel syndrome and other gastrointestinal indications including chronic diarrhea,. Napo plans to market medicines to developing countries before testing the waters back home.

It’s The Overall Survival, Sponsors! Ovarian Cancer Indications Withdrawn For Three PARP Inhibitors

PARP inhibitors appear to be getting the same kind of scrutiny that US FDA has given to P13K inhibitors. AstraZeneca’s Lynparza, GSK’s Zejula, and Clovis’ Rubraca have indications voluntarily withdrawn after ‘potential detrimental effect’ on overall survival seen in randomized clinical trials.

It’s The Overall Survival, Sponsors! Ovarian Cancer Indications Withdrawn For Three PARP Inhibitors

PARP inhibitors appear to be getting the same kind of scrutiny that US FDA has given to P13K inhibitors. AstraZeneca’s Lynparza, GSK’s Zejula, and Clovis’ Rubraca have indications voluntarily withdrawn after ‘potential detrimental effect’ on overall survival seen in randomized clinical trials.

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