“The Pink Sheet” – Most Notable Stories Of 2012
Developments in off-label enforcement and scrutiny of economic superiority claims, new approaches to R&D, and biosimilars are among issues that captured readers’ attention last year.
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If firms could promote drugs for uses not backed by well-controlled studies, it would be “a nightmare,” Temple says; AEI’s Scott Gottlieb suggests the agency might try to regulate how medicines are prescribed.
Some early meeting requests from potential biosimilar sponsors were not held because they did not include the necessary information for FDA to give development advice.
Though it has left behind the “industrialized” R&D approaches from the 1990s, Glaxo thinks its R&D revolution has produced strong growth that will get it back into major markets and maintain an output of three to five significant drug approvals per year. With that progress in sight, the firm is ready to transform its manufacturing and commercial model in the same way it recreated R&D.