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Bridget Silverman

Managing Editor, US Regulatory Analysis

Washington, DC
Bridget joined the Pink Sheet during the very first US Prescription Drug User Fee Act cycle and has maintained a focus on the US FDA’s drug review and approval process. Her role as managing editor of US regulatory analysis builds on her long experience at the Pink Sheet and its earlier affiliated publications Pharmaceutical Approvals Monthly and the NDA Pipeline. She oversees the Pink Sheet’s US FDA Performance Tracker suite of regulatory data, which also inform her coverage of drug development and clinical trial design. Bridget he is always interested in seeing how regulatory policy works out in practice and contributes to the Pink Sheet’s Drug Review Profile series. Outside of work, Bridget keeps track of her family, three dogs, and ever-expanding library of mystery novels.

Latest From Bridget Silverman

Broad Heart Failure Label Ushers Lexicon’s Inpefa Into SGLT2 Inhibitor Market

Sotagliflozin’s cardiovascular outcomes trials support the most expansive heart failure risk reduction claim approved by the US FDA in the class, a turnaround from the drug’s setbacks in type 1 diabetes.

US FDA Performance Tracker Approvals

Big Pharma Companies Have Higher US FDA Approval Percentage Than Everybody Else

Almost 80% of novel agent submissions from the biggest companies were approved in recent years, compared with a 60% approval rate for the rest of the industry, according to a Pink Sheet analysis of FDA approval decisions since 2021.

US FDA Performance Tracker Drug Review

US FDA Complete Response Letter Rates Vary With Sponsor Size

Pink Sheet infographic illustrates benefits of big pharma’s resources and experience.

US FDA Performance Tracker Complete Response Letters

Everybody Stumbles: US FDA Complete Response Letters To Big Pharma

Explore the 20 CRLs issued to biggest pharma firms since the start of 2021 with Pink Sheet infographic describing US FDA’s concerns and current status.

US FDA Performance Tracker Complete Response Letters

Lilly Unlucky? Lilly Leads Big Pharma In US FDA Complete Response Letters

Clinical concerns outweigh quality issues in big pharma CRLs, a Pink Sheet analysis finds, making mirikizumab  the fourth new product candidate sponsored by Lilly to receive a CRL since 2021 – even more of an outlier: it was turned back by FDA because of manufacturing concerns.

US FDA Performance Tracker Complete Response Letters

Everything’s Coming Up Pfizer: The Biggest Of Pharma Firms Leads Industry In Pending Applications For US FDA Approval

Pfizer’s lineup of novel agents under review stands at seven, while no other big pharma has more than two novel candidates; Sanofi is tops in recent approvals since 2021, with seven novel agents cleared, but has no pending NMEs.

US FDA Performance Tracker Drug Review
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