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.
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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.
A new analysis of the ADAURA study shows that Tagrisso’s disease-free survival benefits in early stage EGFRm NSCLC are replicated for brain metastases, a common complication with a poor prognosis. Filings and OS data await.
FDA has heard from some manufacturers that additional time is needed to meet all of the requirements, “especially during the COVID-19 pandemic.” Prior to the pandemic, agency announced enforcement discretion during 2020 for compliance by firms with more than $10m in annual sales.