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Latest From CEL-SCI Corporation

Finance Watch: CARB-X Refills Coffers To Help Biopharmas Fight Resistant Bacteria

Private Company Edition: The global accelerator has new commitments from HHS and the Wellcome Trust. Also, Apollo buys into Sofinnova Partners with an up to €1bn investment, Castle Creek raised $124.6m in private funding this year in lieu of an IPO and Remix closed a $70m series B round. 

Financing Innovation

Hengrui’s PD-1 Camrelizumab Moves Step Closer To US Filing

Positive outcomes from a multiregional Phase III trial provide Jiangsu Hengrui Medicine with a milestone in the Chinese firm's quest for globalization, as it looks to succeed where others have had recent setbacks.

China Clinical Trials

US FDA Advisory Committees As The Court Of Appeals

The US FDA’s use of its advisory committees continues to shrink. In 2022, the expert panels appear primarily to serve as a last chance for sponsors to prevent (or overturn) an FDA rejection.

Advisory Committees Drug Review

Recent US FDA Breakthrough Therapy Designations, From Mass Market Vaccines To Rare Diseases

Merck’s latest pneumococcal vaccine and Pfizer’s RSV vaccine notched new BTDs, along with Zambon’s inhaled antibiotic for non-CF bronchiectasis, Acer’s vascular Ehlers-Danlos syndrome drug and Dizal’s targeted lung cancer candidate.

US FDA Performance Tracker Review Pathway
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