Barr optimistic about biogenerics in 2007: There is "a reasonable chance for passage" of follow-on biologics legislation in 2007, Barr CEO Bruce Downey says during Morgan Stanley CEOs Unplugged conference in New York Jan. 3. "I would suspect that with the change in the composition of the Congress that we will have hearings on that legislation both in the House and in the Senate," he adds, noting that he expects Rep. Henry Waxman (D-Calif.) to reintroduce follow-on protein legislation during the first two weeks of the new Congress, which was sworn in Jan. 4. Waxman, along with Sens. Chuck Schumer (D-N.Y.) and Hillary Rodham Clinton (D-N.Y.), introduced legislation in October that would grant FDA authority to approve comparable or interchangeable follow-on biologics (1"The Pink Sheet" Oct. 9, 2006, p. 5). If a bill is not passed in 2007, Downey said legislation is unlikely in 2008 due to the presidential election, but he "would certainly expect to see legislation by the end of 2009"...
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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.
