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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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The Rebate Rule May Not Last, But It Changed The Pricing Debate

Trump Administration’s attempt to eliminate rebates in the US Medicare outpatient drug benefit program is the easiest and most certain item among the 11th hour pricing policy changes for the incoming Biden Administration to undo. But it still had a major impact on the dynamics of the drug pricing debate.

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The Next COVID Vaccine Race: Comparative Efficacy In Post-Market

Multiple simultaneous sponsors, foreshortened regulatory reviews, and a packet of unanswered post-approval efficacy issues make for what should be very competitive – and inherently comparative – post-market assessment period for the upcoming SARS-CoV-2 vaccines.

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COVID-19 Clinical Trial Disruptions: A Real-World Test Of De-Centralized Techniques

US FDA asks oncology drug sponsors for information on the impact of modifications to clinical trials during the pandemic – with close attention to remote monitoring and data collection.

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AstraZeneca COVID Monoclonal Combination Headed To Clinic ‘Within Weeks’

AstraZeneca devoted a surprisingly large piece of its testimony at the recent House vaccine hearing to its therapeutic work. The company appears to be anticipating another shift in public attention back to the mAB cocktail as a way to treat and prevent COVID-19.

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Re-Wiring US FDA’s Regulatory Thinking

The efforts to upgrade FDA’s information technology infrastructure may be opening up into an opportunity to reinvent its processes for regulatory decision making.

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Re-Wiring US FDA’s Regulatory Thinking

The efforts to upgrade FDA’s information technology infrastructure may be opening up into an opportunity to reinvent its processes for regulatory decision making.

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