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Cole Werble

Washington, DC
Cole Werble is the former owner and editorial director of FDC Reports, Inc., the publisher of The Pink Sheet, The Gray Sheet, and other leading news publications for the health care industry. He has more than 35 years of experience analyzing business critical developments affecting the biopharma sector and developing world class information products for the sector.
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Latest From Cole Werble

Podcast: What Commissioner Gottlieb Will Mean For The US FDA

Experts from Prevision Policy discuss their initial impressions of Scott Gottlieb as President Trump's choice to lead FDA, his unique policy experience, what it means from the drug industry, 'Council of Elders' drug approvals, and how his selection could impact the user fee negotiations.

FDA Leadership

US FDA's Authority Over CRISPR Is Adequate, NASEM Finds, But Off-Label Challenge May Emerge

National Academies’ report on the fast-advancing genome-editing technologies points out that ways to improve musculature in dystrophy patients will almost certainly raise issues about treatment use in narrow population versus enhancement use in broader population. In most cases, however, specificity of genome-edited products will help limit use of the new therapies to targeted populations.

FDA Policy

Medicaid Reform And Rebates: State “Opt-Out” Proposed At Hearing

Medicaid rebates have been a fact of life in the pharmaceutical industry for 25 years. But the Affordable Care Act repeal-and-replace debate may open up the possibility of eliminating the mandatory rebates – and the requirement that all drugs be covered by the program.

Government Payers Reimbursement

Podcast: US FDA’s ‘Within Label’ Definition Allows Companies To Elaborate On Indications

Permitted speech for approved products could shift dramatically depending on how hard a Trump FDA Commissioner pushes, but the expansion at the end of the Obama Administration is a significant step in its own right – one that former Commissioner Rob Califf emphasizes in an interview that is also available as a podcast.

Advertising, Marketing & Sales Regulation

Podcast: Silicon Valley's FDA

Perspectives on two individuals – James O’Neill and Balaji Srinivasan – under review for potential high-level posts at the US agency, plus lessons learned from how FDA topsiders have been selected in the past.

FDA Policy

Drug Pricing ‘Opacity,’ Degrees Of Transparency Debated By National Academies Panel

Second meeting of National Academies drug pricing committee was far-reaching discussion of several major themes, including PBM transparency, the political future for co-pay coupons and the next possible inflection point: the potential $1 million price tag for gene therapies.

Pricing Debate Legislation
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