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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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
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This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

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We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 

A new pilot aims to take Brazil closer to ‘digital transformation.’

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Trump Tariffs: Indian Pharma Dodges Bullet, But Sword May Remain

 
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Trump announced a 26% reciprocal tariff on India, but a country-agnostic exemption of pharmaceuticals implies that the interests of Indian firms are protected for now. What is Indian pharma’s business exposure and what is domestic industry saying?

Dr. Oz Takes Over CMS Amid Major Transformation Of Medicare Part D

 
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As CMS administrator, Mehmet Oz will oversee the second cycle of Medicare drug price negotiations and Part D redesign issues, but will have experienced deputies to help.

US FDA Restructuring May Be Next After Drugs Center Loses More Than 1,000 People

 

The departure data emerged along with a Health and Human Services Department memo describing conceptual plans to consolidate and restructure offices at the FDA and other agencies.