Tags : FibroGen

Viewpoints

ViewPoints Interview: FibroGen’s Peony Yu Shares Insight on Roxadustat

In a recent interview with PharmaShots, Peony Yu, Chief Medical Officer of FibroGen shared her insights and highlights on data of Roxadustat Shots: FibroGen presented new efficacy and safety analyses from the roxadustat global P-III program at ASN Kidney Week 2020 Reimagined. FibroGen and its partners, AstraZeneca and Astellas, presented 42 abstracts, including 2 late-breaker […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshot (Jun 22- 26, 2020)

 1.  EMA’s CHMP Recommends the Approval of Two Biosimilar Referencing Lilly’s Forsteo (teriparatide) for the Treatment of Osteoporosis Published: Jun 26, 2020 | Tags: EMA, CHMP, Recommend, Approval, Two, Biosimilar, Referencing, Lilly, Forsteo, teriparatide, Osteoporosis 2.  Medtronic Receives the US FDA’s Approval for its Percept PC Neurostimulator with BrainSense Technology Published: Jun 25, 2020 | Tags: Medtronic, […]Read More

Insights+

PharmaShots’ Key Highlights of Third Quarter 2019

The third quarter of 2019 has ended with major acquisitions in the pharma and biotech industry along with multiple approvals. Starting with the latest acquisition where Biocon Biologics acquires Pfizer’s Research Facility for expansion of its R&D footprints with the acceleration of the development of its biosimilars from lab to pilot scale. Previously, Amgen acquired […]Read More

Regulatory

Astellas and FibroGen’s Evrenzo (roxadustat) Receives MHLW’s Approval for Anemia

Shots: The approval is based on four P-III studies evaluating Evrenzo (20/50/100mg) in CKD anemic patients on dialysis in Japan, demonstrating increment in hemoglobin level and is well tolerated among the patients, marking the first approval of the collaboration Astellas and FibroGen collaborated to develop Evrenzo for treating anemia in Japan, Europe, the Commonwealth of […]Read More

Regulatory

AstraZeneca and FibroGen’s Roxadustat Receive NMPA’s Approval for the Treatment

Shots: The NMPA’s approval is based on P-III study result assessing Roxadustat vs PBO in non-dialysis-dependent (NDD) patients with CKD demonstrating improvement in hemoglobin levels with a mean change of (1.9 g/dL vs -0.4 g/dL) on 7-9wks. treatment In 2013, AstraZeneca and FibroGen collaborated for the development & commercialization of Roxadustat in China. The NMPA’s […]Read More