BIO’s Evergreening Project: CEO Greenwood Discusses Cost-Effectiveness And The “Inevitability” Of Follow-On Biologics

James Greenwood joined the Biotechnology Industry Organization as president and CEO in January 2005 after 12 years in Congress. His priorities early on were to prevent drug safety worries from slowing approvals and to ensure the quality of BIO as an advocacy organization. Editors from "The Pink Sheet" spoke with Greenwood earlier this year about the challenges and opportunities facing the biotechnology industry in 2006.

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Pink Sheet Podcast: Vaccine Review Political Interference, Missed Deadlines A Harbinger Of US FDA Problems?

Pink Sheet reporter and editors discuss FDA Commissioner Martin Makary’s decision to have one of his assistants lead negotiations for Novavax’s delayed COVID-19 vaccine review, as well as some recent missed review deadlines, which may be the result of recent FDA cuts.

Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 

Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 

Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.