Top Seven Pink Sheet Infographics Of 2023

A visual perspective on key regulatory topics in 2023, from clinical trial diversity to product approval trends and Medicare drug price negotiation.

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Pink Sheet draws attention to hot topics in regulation. • Source: Shutterstock

The Pink Sheet regularly features infographics and interactive charts illuminating key regulatory topics and our analyses. Our readers find these help them more easily understand emerging patterns and trends, track milestones for important programs, learn from peers and benchmark their own performance. Our graphics are often anchored with specific examples of companies and products; comparisons by company types, therapeutic areas or regulatory regions; and other information that aids readers in applying the information to their own strategies.

It's difficult to highlight just a few as the best of 2023. But below are an editor’s choice of seven...

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Navigating The EU's Revised Clinical Trial Disclosure Rules

 
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The European Medicines Agency is preparing to roll out simplified transparency rules for its Clinical Trials Information System in mid-2024. This article looks at what will change and the impact on the thousands of trials that are already in the system.

EU’s Innovative Drug Approval Tally Shows Sharp Decline

 
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The numbers may be down, but Europeans will in future be able to gain access to a number of highly innovative medicines, including several products for hard-to-treat cancers, a gene therapy for severe and moderately severe hemophilia B, and two vaccines against disease caused by respiratory syncytial virus.

As 2024 Begins, US FDA’s Novel Agent Prospects Look A Lot Like 2023

 

Immuno-oncology will remain a major force at both FDA’s drugs and biologics centers, but watch for psychiatry and antibiotics to make some noise; rare pediatric diseases will remain prominent as the priority review voucher program heads into the sunset.

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COVID Vaccines: US FDA Changes Course, Wants New Formulas To Target KP.2 Subvariant ‘If Feasible’

 
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Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’

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Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.

PinkSheet-R&D-Free: ‘Ranking’ article that includes different Composer content

 
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To make your document look professionally produced, Word provides header, footer, cover page, and text box designs that complement each other. For example, you can add a matching cover page, header, and sidebar. Click Insert and then choose the elements you want from the different galleries.