Noven Gains Brisdelle Approval Over Advisory Committee Concerns
This article was originally published in The Pink Sheet Daily
Low dose version of paroxetine indicated for hot flashes even though advisory committee members questioned trials’ placebo effect.
You may also be interested in...
Conditions associated with menopause represent a huge market, yet the R&D pipeline has long been slim, despite the well-known drawbacks of marketed hormone replacement therapies. But new approaches with a tissue-selective estrogenic effect are emerging: Shionogi’s Osphena for menopause-related sexual dysfunction broke the long drought in NME approvals, and Pfizer’s broad NDA for bazedoxifene/conjugated estrogens is under review. Emerging companies like EndoCeutics are exploring new hormonal approaches.
Trial diversity is among the issues that stakeholders worry could hinder vaccine uptake.
Pink Sheet Podcast: COVID-19 Stresses Manufacturing, Vaccine Placebo Controls, Thorny FDA Precedents
Pink Sheet reporters and editor discuss the pandemic’s effects on non-coronavirus-related product manufacturing, US FDA efforts to ensure vaccine sponsors maintain placebo controls once a product is available, and precedents that burden the agency.