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Zebra Biologics Inc.

Latest From Zebra Biologics Inc.

Rx For Immuno-Oncology Excess? Top US FDA Cancer Officials Take On Development ‘Wild West’

Rapid, uncoordinated growth has turned the PD-1/L1 inhibitor pipeline into a global stampede, FDA’s Pazdur and Beaver say. Solutions like a unified submission pathway and coordinated trial design pose challenges requiring international cooperation among governments and industry alike.

ImmunoOncology Clinical Trials

US FDA’s Foreign Data Policy Faces Its Greatest Test From Chinese PD-1/L1 Inhibitors

The swift rise of China’s oncology R&D has put at least four novel applications before FDA with pivotal data generated only in China.

ImmunoOncology Drug Approval Standards

Consolidation And COVID See Off-Patent Industry Rankings Rewritten

After an extraordinary year that saw demand patterns and the supply chain upended by the COVID-19 pandemic, as well as a major merger that has transformed one of the global off-patent industry’s biggest players, Generics Bulletin’s Top 50 has once again seen significant changes.

Sales & Earnings Biosimilars

Keeping Track: Breakthroughs Of Summer Break Ground In Psychiatry, Cancer (Especially Nasopharygeal Cancer) And Vaccines

US FDA’s marquee expedited review program added 15 new breakthrough therapy designations between June and August.

US FDA Performance Tracker Review Pathway
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