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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

Biodefense Bill Moving In Senate; Still Debate Over Best Approach For Flu

US Pandemic and All Hazards Preparedness Act appears on track for on-time reauthorization – but there may still be debate over whether and how to dedicate funding specifically for pandemic flu preparedness and stockpiling.
Infectious Diseases Legislation

NSAID Comparative Safety: PRECISION Study, FDA Pertinacity … And Anti-Clotting Agents?

US FDA's planned advisory committee on comparative safety in the NSAID/COX inhibitor area shows agency's staying power on safety issues.  

Nicotine Replacement Trials and The App Effect

Encouraging a new generation of nicotine replacement drug products is a key component of FDA’s renewed effort to cut nicotine addiction and smoking. It may also be a good place for the broader biopharma community to look for the impact of health apps and personal digital equipment on trial design and showing efficacy.
Digital Health Drug Approval Standards

US FDA Approval Versus Patient Access: A Real-World Anecdote

During meeting on real-world evidence, FDA’s Bob Temple describes real-world problem of patient access: his struggles to convince his insurer to cover Lilly/BI's diabetes drug Jardiance – which he helped review.  
Reimbursement Drug Approval Standards

PBMs Play Outsized Role … In Hearing On Health Sector Consolidation

PBMs have become a central focus of the drug pricing debate, thanks in large part to the biopharma industry’s efforts to shine a spotlight on the role of rebates and middlemen in consumer costs. They were also a surprising focus on a hearing about health industry consolidation. 

An Image To Maintain: GAO Profit Picture Of Drug Industry Is Good To Store Away For Future Debates

Big pharma has been highly successful at changing the debate from the level of drug company profitability to who shares what part of dollars generated by drug sales, but there are still lingering efforts to define and describe overall drug industry profitability and put it in the overall context of the broader economy. These efforts are backburner for now but will come back at some point in the future. Some of the portrayals are friendlier to pharma than others.

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