Senate Rx Import Bill Will Add Stronger Anti-Counterfeit Provisions In 2005
• By Tericke Blanchard
When Health Committee Chairman Judd Gregg (R-N.H.) reintroduces his drug importation bill, it will include requirements for full drug "pedigrees" on imported drugs. Legislation could also set up requirements for pedigrees on domestic drugs.
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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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There is a place for using external reference pricing to set prices of advanced therapies, but any such mechanism must take into account the specificities of the Brazilian market and health system.
Lerodalcibep and palbociclib are among the latest new drugs that the European Medicines Agency has started to review for potential EU marketing authorization.
Country recommends eights new drugs for approval, including six for rare diseases, and also announces macroeconomic policy the pharma industry says would enable some reimbursement prices to be raised.