FDA’s Longtime Approach to New Chemical Entity Designations Now Codified

Axinn partners Brian Johnson and Joseph Micallef have been selected to participate as coaches for the International Trade Commission Trial Lawyers Association’s Mock Hearing Program in Washington, DC on November 12. Associates Raymond Braha and Cassie Goodnight have been selected to participate as NEXT Advocates. 

Axinn is pleased to announce that it is acting as regulatory counsel to Thermo Fisher Scientific Inc. (“Thermo Fisher”) in its recently announced definitive agreement to acquire Clario Holdings, Inc. (“Clario”), a global leader in clinical-trial endpoint data solutions, from a shareholder group led by Astorg and Nordic Capital, Novo Holdings, and Cinven. The transaction, valued at approximately $9 billion in cash at closing, plus potential additional performance-based payments, underscores Thermo Fisher’s strategy to deepen its digital, data, and artificial intelligence capabilities in clinical research and biopharma services markets. Following the close, Clario will become part of Thermo Fisher’s Laboratory Products & Biopharma Services segment.