Newsletter | May 31, 2023

05.31.23 -- 3 Pharmas Try To Solve The Dermatology Puzzle

New Podcast Episode
Featured Articles
The Skin Is The Game: New Ways To Play In Dermatology

As the established indications in dermatology become saturated with competing products, a variety of companies, from startups to oncology players, are finding opportunities in underserved indications and reformulated drugs.

Fortress Biotech’s Network Flex Business Model

Fortress Biotech CEO Lindsay Rosenwald talks up Fortress Biotech’s business model, which leverages partner companies to develop promising but underexposed drug candidates.

8 Key Takeaways For FDA Inspections In The FDORA

With President Biden’s signature, the Food and Drug Omnibus Reform Act of 2022 (FDORA), part of the larger Consolidated Appropriations Act of 2023 (Public Law 117-328), became law on Dec. 29, 2022.  FDORA expands and modifies the inspection authority of the FDA in several key areas, including alternative tools to inspection, mutual recognition agreements, bioresearch monitoring, and unannounced foreign inspections.

Web-Exclusive Content
Phase 1 Strategies To Optimize Orphan Drug Development

While evidence of clinical activity is often sought and collected during Phase 1 trials, it is not typically the primary trial endpoint. But in later-stage trials such as a Phase 1b dose expansion study, there are opportunities to collect additional critical data that will help to guide further development. This includes clinical activity, biomarker and genetic mutation assessments, and preliminary impact in combination therapy. 

Digital Edition
May 2023 Digital Edition

Inside you will find more on:

  • Regulatory Topics
  • Leadership Tips
  • Exclusive Interviews
  • Original Research

View the digital edition.

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