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Weekly Pharma News Review | PharmaSources.com (0808-0812)

Weekly Pharma News Review | PharmaSources.com (0808-0812)

by PharmaSources.com

August 17, 2022

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The FDA approved the supplementary new drug application for Bayer's darolutamide in combination with docetaxel, which sparked widespread social attention. The news review of this week is from August 8 to 12, covering 23 pieces of information in 3 sections.

Drug Review

NMPA – Marketing

[Application]

1. On August 10, the CDE official website revealed that the marketing application for Roche's monoclonal antibody injection (Crovalimab) was accepted and included in the priority review. It is for the treatment of adults and adolescents (>=12 years old) with paroxysmal nocturnal hemoglobinuria who are not currently receiving complement inhibitor therapy. Crovalimab is expected to be Roche's first innovative drug to have China as its world debut location.

2. On August 10, the CDE official website revealed that the marketing application for the new indication of vonoprazan fumarate tablets of Takeda was accepted, which was presumed to be the eradication of Helicobacter pylori (HP) in combination with appropriate antibiotics. Vonoprazan fumarate tablets have been approved by NMPA in December 2019 for the initial treatment of reflux esophagitis and in October 2021 for the maintenance treatment of patients with recurrent reflux esophagitis.

NMPA – Clinical Trials

[Approval]