Newsletter | August 3, 2022

08.03.22 -- Converting FDA Complete Response Letters Into New Opportunities

 
Featured Articles
Peeling Back The Layers Of The Digital Health Onion
 

Digital health has radically changed patient care globally and disrupted healthcare, while also increasing speed and efficiency through new healthcare models.

KemPharm: Converting FDA Complete Response Letters Into New Opportunities
 

KemPharm’s experience in reworking product NDAs following FDA Complete Response Letters has created a unique capability within the company and helped it move to acquire a potentially valuable asset from distressed biopharma Orphazyme.

Living Diversity, Inside Mink Therapeutics
 

We sought out a biopharma enterprise where diversity always has been an operating principle, where it feeds the company’s intellectual life and creative culture, and where it is demonstrable yet still evolving.

Web-Exclusive Content
Decentralized Clinical Trials: Are We Using The Best Terminology For Patients?
 

There is a need within the clinical trials community for a broad term to describe clinical trials that make use of digital health tech and other methods for better accessibility to participants. However, is a single term as helpful for patients as it is for clinical trial professionals?

Industry Insights
Effects Of The Ongoing Pandemic On Bupivacaine HCI Supply

Throughout the pandemic, painkiller and sedative demands have spiked. Drug manufacturers and CDMOs have become critical in efforts to stabilize the supply of Bupivacaine HCl and other essential drugs.

Risk Vs. Resilience: Striking A Balance In The Biopharma Supply Chain

What are the biggest vulnerabilities in today’s biopharmaceutical supply chain, and what can suppliers to do address them?

Digital Edition
August 2022 Digital Edition
 

Inside you will find more on:

  • Alnylam CEO Interview
  • Companies To Watch
  • Supply Chain Issues
  • Company Culture

View the digital edition.

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