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Monthly Archives: October 2012
The Path of Least Resistance: Repositioned Drugs Surpass New Brands
It was in 1984 when FDA first added the 505(b)(2) pathway for drug approval, a hybrid between the accelerated pathway for generic drug applications, and the standard de novo NDA pathway for proprietary drugs. But in the past 6 years, approvals received through the 505(b)(2) pathway have consistently outnumbered de novo NDAs.
Posted in Biotech, FDA, IP, R&D, Regulatory, Strategy Leave a comment
Obamacare After Nov 6th: Trouble for Pharma?
by Tom Norton
No doubt the November 6th election is going to be close, very close: close for the Presidency, close for the Senate, and possibly close for the House. So close, in fact, it’s possible that no substantial political change will occur in Washington, as a result.
That said, for the U.S. pharmaceutical industry this is [...]
Posted in Events, FDA, Legal, Market Access, R&D, Regulatory, leadership, pricing Tagged ACOs, CER, IPAB, Obamacare, PCORI 3 Comments
Spanish Generics Industry to Government: "Leave Branded Pharma Alone"
Just days before the reports that R&D investment in Spanish pharma had fallen to below EUR1 billion ($1.3 billion) in 2011 for the first time since 2007, the country’s generic manufacturers association, AESEG, offered some unexpected support for the branded industry.
In comments to APM Health Europe described as “rare”, AESEG chief Ángel Luis Rodríguez de [...]
Posted in Europe, Global, healthcare Tagged AESEG, Angel Luis Rodriguez de la Cuerda, Cuts, eurozone, Faramindustria, generics, Spain Leave a comment
Merck and Novartis Down in Q3 Financial Reports