Change At White House And Proof Of User Fees’ Value: ‘ACNU’ Final Rule Publication Drivers?

(Source: Shutterstock/Citeline)

Either the clock was ticking or the sands in the hourglass were dwindling before the recent publication of a US regulation to allow sales of OTC drugs using digital labeling for consumers’ self-selection of “additional conditions for nonprescription use” more than a decade after the Food and Drug Administration suggested the change.

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Over The Counter: What To Expect From The 61st AESGP Annual Meeting, With Jurate Švarcaite

 
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HBW Insight speaks to AESGP director general Jurate Švarcaite about what's on the agenda for the upcoming 61st AESGP Annual Meeting, which will take place in Warsaw, Poland, between 2-4 June. Highlights include the role of prevention in self-care, discussions about how regulators will ensure the competitiveness of European industry on the world stage and incoming changes to sustainability legislation.

‘Nothing Unexpected’ In Third Failed Application For OTC Sildenafil In Germany

 
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“Overall, no unexpected/new data or findings” were presented to Germany's Expert Committee for Prescription in the most recent Rx-to-OTC switch application for sildenafil (25mg and 50mg), according to medicines regulator BfArM, resulting in a third rejection in three years.

Over The Counter: Women’s Health Innovation And Beyond, With Maxwellia’s Anna Maxwell

 
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HBW Insight catches up with Maxwellia CEO Anna Maxwell to discuss her company's journey so far, and what she sees as the opportunities for Rx-to-OTC switch in UK women's health and beyond.

Over The Counter: The Challenge Of Innovating In A Changing OTC Industry With AdverCheck’s James Walmsley

 
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Advercheck managing director James Walmsley talks to HBW Insight about the challenges facing consumer health companies today as they move away from the prescription medicines sector and its pipeline of switchable ingredients towards self-care and prevention.

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US Beauty Deals: Kim Kardashian Buys Back Beauty Brand Rights From Coty, L’Oréal’s NYX Professional Makeup Teams With Warner Bros.

 

Kim Kardashian lifestyle company SKIMS buys back rights to SKKN by Kim from Coty, Inc., which had purchased a 20% interest in the brand in 2020 for $200m. Separately, NYX Professional Makeup partners with Warner Bros. to launch the “A Minecraft Movie” collection.

Swisse Benefits As Supplements Considered ‘Daily Necessity’ In China

 
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Chinese consumers are now routinely taking supplements for a variety of health reasons, helping to drive up sales of the Swisse Plus+ brand by 20% in 2024.

US FDA Under Makary: MAHA With A Lighter Touch

 

US FDA Commissioner nominee Martin Makary is being embraced by industry, and Senate Democrats, as a more traditional pick than other Trump Administration nominees, but the Make America Healthy Again agenda still is clearly coming to the agency.