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Latest From FibroGen, Inc.
First quarter earnings preview: US drug pricing reform, an uncertain regulatory outlook and new focus on M&A are rising challenges that could put the industry's growth at risk.
In this latest installment of VC playbook, In Vivo speaks to Naveed Siddiqi, senior partner at Novo Ventures. He discusses the group’s strategy, the European investment outlook for life sciences and how COVID-19 has permanently shifted perceptions of the biopharma industry.
Roxadustat Approval Might Hinge On Additional Safety Analyses After FibroGen Admits Manipulating Data
With superiority over epoetin apparently off the table, FibroGen and AstraZeneca expect a US FDA advisory committee in July, and hope that additional safety analyses for roxadustat will help support a positive overall risk-benefit profile.
AstraZeneca's partner FibroGen stunned investors and regulators by announcing that previously disclosed cardiovascular safety data for CKD candidate roxadustat included changes made post hoc, rather than as pre-specified with the US FDA.
- Other Names / Subsidiaries
- FibroGen China Anemia Holdings Ltd.
- FibroGen (China) Medical Technology Development Co., Ltd.
- FibroGen Europe Oy
- FibroGen International (Cayman) Limited
- FibroGen International (Hong Kong) Limited
- Skin Sciences, Inc.