Pharma has come a long way in the last three years in developing tactics to respond to large, government-funded comparative clinical trials. Aggressive and well-prepared responses by the antipsychotic manufacturers to the CATIE comparison of four atypical brands to perphenazine changed what could have been a threatening study into an event for publicizing the strengths of individual brands.
By Cole Werble
The media grabbed its message quickly.
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The FDA deputy commissioner emailed staff asking anyone interested in the position to send her their curriculum vitae, an unusual method for finding candidates for a high-level position.
Pink Sheet reporter and editors explain Tidmarsh’s abrupt resignation as the FDA’s chief drug regulator and the potential impact on the already reeling agency.
The 27-year agency veteran has not been formally approached about filling the vacancy created by George Tidmarsh’s resignation, but also is not interested in the position, the Pink Sheet has learned.
Employees subject to the April 1 reduction-in-force began noticing severance payments had been stopped the week of Nov. 3, before the FDA Office of Human Capital Management announced the suspension of all payments to former staffers due to the lapse in appropriations.
As more medicines come off patent in the coming years, the UK generics and biosimilars industry association is hoping to see more generic products evaluated for reimbursement by the health technology assessment institute, NICE.
Sam Roberts, chief executive of England’s NICE, has defended the health technology assessment institute’s cost-effectiveness thresholds and the country’s ranking against other nations when it comes to market access, while acknowledging that the UK’s pharma ecosystem is “really tough.”
The 27-year agency veteran has not been formally approached about filling the vacancy created by George Tidmarsh’s resignation, but also is not interested in the position, the Pink Sheet has learned.
