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Gilead Gets Positive EU Opinion On Proprietary HCV Combo Pill Harvoni

This article was originally published in The Pink Sheet Daily

Executive Summary

Europe’s top scientific advisory panel has cleared for approval Gilead’s new hepatitis C antiviral combination of sofosbuvir plus ledipasvir, as well as Almirall’s new inhaled combo of aclidinium and formoterol and AstraZeneca’s new constipation therapy naloxegol.

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Transforming A European Mid-Sized Pharma: An Interview With Almirall President Jorge Gallardo

Spain’s Almirall has taken a step back from the hypercompetitive respiratory market through its deal with AstraZeneca. It was becoming too expensive to compete in primary care against big pharma, says company President Jorge Gallardo. Almirall will use proceeds to chart a future course as a specialty pharma focused on dermatology.

Gilead Stands Its Ground With Harvoni: HCV Price War Less Likely

Firm makes clear that pricing of Harvoni is meant to match the cost of Sovaldi plus the interferon/ribavirin therapeutic backbone. Despite stakeholder criticism, Wall Street expects Gilead’s competitors will not attempt to compete via price.

Harvoni Cost Will Be Roughly Equal To Sovaldi For Most HCV Patients (Updated)

Sovaldi/ledipasvir combo pill – the first one-tablet, oral hepatitis C option in the U.S. – was approved Oct. 10 with a price of $94,500 for a 12-week course of therapy, similar to the cost of Sovaldi plus interferon and ribavirin. Insurers group says Gilead “seems to believe it has a blank check.”

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