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Brenda Sandburg

New York, NY
Brenda Sandburg is a senior writer who covers legal issues and FDA regulatory policy, with a particular focus on patents, biosimilars, and government investigations. She spent 10 years writing for legal publications between stints at The Pink Sheet and blends these experiences to provide in-depth analysis of events. An aspiring photographer, she enjoys taking photos to accompany news stories.

Latest From Brenda Sandburg

Heightening Focus On Hemp, Cannabis, US FDA Hires Norman Birenbaum As Public Health Advisor

Hemp industry and private attorneys glad Birenbaum, who was the chief cannabis policy advisor to governors of New York and Rhode Island, given prominent role at FDA that could spur regulatory action.

Cannabidiol CBD FDA

US FDA Heightens Focus On Cannabis With Hiring Of Norman Birenbaum As Public Health Advisor

Industry reps are glad that Birenbaum, who was the chief cannabis policy advisor to the governors of New York and Rhode Island, was given a prominent role at FDA that could spur regulatory action.

Cannabidiol CBD FDA

Former FDA Chief Counsel Elizabeth Dickinson Hailed For Her Expertise, Warmth And Mentorship

Dickinson, who joined the Office of Chief Counsel in 1994, retired on 24 September. Former colleagues note the impact she had within and outside the agency, particularly as the ‘legendary leader’ of the legal approach to generic drugs.

FDA Legal Issues

It’s The Overall Survival, Sponsors! Ovarian Cancer Indications Withdrawn For Three PARP Inhibitors

PARP inhibitors appear to be getting the same kind of scrutiny that US FDA has given to P13K inhibitors. AstraZeneca’s Lynparza, GSK’s Zejula, and Clovis’ Rubraca have indications voluntarily withdrawn after ‘potential detrimental effect’ on overall survival seen in randomized clinical trials.

Clinical Trials Cancer

Poziotinib Fails To Get FDA Panel Support Though Members Not As Dubious As Agency

Agency’s recent approval of Enhertu, which has better response rate, sways some panel members to vote against Spectrum’s NSCLC drug. FDA’s Pazdur compares poziotinib’s dosing uncertainty to ‘building a house on quicksand.’

Advisory Committees Drug Review

‘On-And Off-Ramps’ For Cancer Accelerated Approvals: FDA Suggests Earlier Randomized Trials

Leaders of FDA’s oncology center say sponsors could initiate a single randomized trial prior to receiving accelerated approval or conduct a single-group AA study concurrently with a randomized trial. FDA and sponsor could agree in advance on criteria for approval and withdrawal.

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