Policy & Regulation


Longer ACNU Rule Review Gets Kennedy Signature

 

Notice published on 21 March is a word-for-word copy, other than different dates, of a document published on 24 January, Kennedy says the ACNU final rule’s effective date is delayed until 27 May, two months later than the initial delayed effective date.

US Monograph Facility Fees Due In Six Weeks While DOGE Subjects FDA To Rapid Changes

 

FDA’s OMUFA facility fees for FY2025, due on 2 June, increase nearly $2,400 to $37,556 for OTC monograph drug manufacturers and $2,200 to $25,037 for contract manufacturers. Overall target OMUFA fee total is just short of $36.47m, up from $32.25m for FY2024.

US FDA Questions Third-Party Labs’ Benzene Testing Methods As Acne Products Recalled

 
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FDA testing of 95 benzoyl peroxide products due to concerns about elevated benzene detected by third-party testers found 90% with undetectable or extremely low benzene levels.

‘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.

Business


People On The Move: Appointments At GSCF, Kenvue, Barentz

 
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A round-up of the latest consumer health industry appointments: GSCF elects chair; Kenvue hires Northern Europe head; Barentz names chief commercial officer.

Galenica OTC Goes From Strength To Strength At Home And Abroad

 
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Galenica outpaced the growth of the OTC market at home, while recording a double-digit gain abroad, to drive up its consumer health product sales in 2024.

Alliance Pharma Takeover Wins Shareholder Backing After Increased Offer

 
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Alliance shareholders overwhelmingly back takeover by DBAY Advisors after improved offer values UK-based firm at £362m.

New Product Launches Ensured Growth For Stada CHC In 2024

 
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Like many European firms, Stada Arzneimittel's 2024 earnings were held back by a soft cough, cold and flu season. However, key launches in its home market Germany and in the Middle East offset this impact and led to 3% organic growth for Stada's Consumer Healthcare business.

Innovation & IP


Bayer Study Shows Potential Of Saliva-Based Biomarker For Healthy Aging

 
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Bayer Consumer Health hopes its new InflammAge saliva-based biomarker can help “revolutionize self-care and how people can manage their aging journey.”

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.

Haleon Launches ‘Prescription Strength’ Hayfever Remedy In The UK

 
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Pirilieve Hayfever Relief Tablets contain 120mg fexofenadine hydrochloride, which the firm notes is an active ingredient that was “previously only available behind pharmacy counters.”

Haleon’s US Eroxon Launch Falls Short Of Expectations

 
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Consumer uptake of Eroxon - the first FDA-approved OTC ED treatment available in the US - has been slower than expected, according to Haleon, which says its working with retailers to build awareness.

Rx-to-OTC Switch


‘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.

Germans Favor Bricks-And-Mortar Pharmacy Over Mail-Order For OTCs

 
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Almost two thirds (62%) of respondents to an online survey said they would rather buy non-prescription medicines in a local pharmacy than via a mail-order pharmacy, Pharma Deutschland reports.