Category Archives: FDA

Why the Delay on Facts Boxes?

By Ben Comer | Published: November 16, 2011
Despite a near-complete absence of criticism coming from industry, academia, clinicians and patients, the drug facts box – a concise, quantitative, easy-to-read format for presenting a drug’s risk/benefit profile in print advertisements – seems at least three years away from launch.
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Got Ideas About Medicare and Medicaid Reform?

By Ben Comer | Published: October 26, 2011
The Center for Medicare and Medicaid Innovation (CMMI) is now accepting applications for its Innovation Advisors Program. The CMMI, created by the Affordable Care Act, is tasked with “testing new models of healthcare delivery and payment.”
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Prix Galien: Pharma R&D and Payers Need to Talk, Yesterday

By Ben Comer | Published: September 28, 2011
R&D departments and payers need to communicate early in the drug development process: If pharma is a day late, then payers are likely to be a dollar short, according to panelists at the Galien Forum on Tuesday.
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Mission Critical: Innovation and American Business

By Ben Comer | Published: September 14, 2011
On the heels of President Obama’s unveiling of the American Jobs Act, Synta Pharmaceuticals CEO Safi Bahcall  – who attended the president’s jobs speech last week as a special guest of House Speaker John Boehner (R-OH) – spoke to Pharmaceutical Executive about the role of government in supporting innovation.
Also posted in Europe, Global, IP, R&D, Regulatory, Strategy, healthcare, leadership | Tagged | 1 Comment

First Orphan Launch a Challenge for AstraZeneca

By Ben Comer | Published: August 2, 2011
Four months after AstraZeneca received FDA approval for vandetanib, a treatment for inoperable medullary thyroid cancer, the company announced the drug’s trade name: Caprelsa. FDA said other proposed names – Zactima, for example – too closely resembled other currently marketed proprietary names. Getting FDA approval on a brand name for vandetanib, AstraZeneca’s very first orphan drug, isn’t [...]
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