Biotechnology Industry Organization President and CEO Jim Greenwood reflects on the trade group's legislative priorities in 2007 as the new Democratic-controlled Congress gets to work. Greenwood joined BIO in January 2005 after 12 years in Congress as a Republican Representative from the 8 district of Pennsylvania. In Congress, he served as chairman of the Energy and Commerce Committees Subcommittee on Oversight and Investigations, where he led a review of drug reimbursement issues and contributed to the passage of the Medicare Modernization Act of 2003.
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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.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.
For the Trump Administration, the blockbuster GLP-1 drugs for obesity have become a poster child for the disparity between US and foreign prices.
Pink Sheet reporter and editors consider the issues that could emerge during upcoming private FDA forums with pharma CEOs, as well as the impact of the surprising move by HHS Secretary Robert F. Kennedy Jr. to limit the CDC recommendation for annual COVID-19 vaccine boosters.
