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Health (OTC Drugs)

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Regulation/Legislation Explore this Topic

Set Alert for Regulation and Legislation {Health}

Latest From Regulation, Legislation & Health

Over The Counter: Solving The Sustainable Pill Pack Puzzle, With PA Consulting’s Tony Perrotta

In this episode of the updated Over The Counter podcast, HBW Insight speaks to sustainable packaging expert Tony Perrotta about the complexities of replacing plastic pill packs in medicines packaging. Perrotta is a partner at PA Consulting, which set up the Blister Pack Collective alongside consumer health players Haleon, Bayer and Sanofi. They are working with PulPac, which has invented a dry molded fiber alternative to plastic, which the Collective hopes to commercialize within 12-24 months. We discuss whether regulators will accept such alternatives, given the safety and stability requirements for medicines, and the challenges of recycling, given the multitude of different frameworks and processes across the world. Perrotta also reveals that one of the partners in PA Consulting’s Bottle Collective, which hopes to replace plastic bottles in the food, personal care and consumer health industries, will soon launch its first market trial.

International Health

AESGP: Despite MDR Failures, ‘Complete Overhaul’ Not Needed

The Association of the European Self-Care Industry gives EU regulators a to-do list of targeted reforms to save the Medical Devices Regulation from the scrapheap.

Europe Health

Without Additional Funding, US FDA's Inspections In Jeopardy – Regulatory Affairs Chief

Without additional funding, FDA’s ORA faces challenges in retaining and hiring staff, which will impact inspections, says office chief Michael Rogers. 

FDA Enforcement

Need Advice About Advisory Committees, US FDA? Try Having Some

FDA’s drug center has all but stopped holding meetings at this point, which begs the question: why do they want advice on how to make them better?

Advisory Committees Prescription To OTC Switch

FDA Advisory Committee Reform: Does Listening Session Suggest No Major Near-Term Changes?

FDA seeks feedback at 13 June virtual hearing on three general topics related to advisory committees: panel composition, barriers to service for Special Government Employees, and public perception and understanding of the process.

Advisory Committees Prescription To OTC Switch

Federal Judge Knows ‘Clear’ When He Reads It

The regulation “is clear, as is the Court’s order” rejecting CRN’s motion for preliminary injunction against imposition of the regulation, says US district Judge Andrew Carter in order denying the trade group’s request for clarification of New York regulation.

Litigation Dietary Supplements
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Business Explore this Topic

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Latest From Deals & Health

‘Meaningful Revenues’ In 2023 Mark Strategic Milestone As Futura Looks To Future

Futura recorded its first notable revenues last year, generated by the launch of its Eroxon erectile dysfunction gel in the UK and Europe, marking the company's transition from an R&D startup to a consumer healthcare player in its own right. To mark the occasion, CEO James Barder outlines a new strategy, with a focus on innovation in sexual wellness, further global partnerships and sustained profitability. 

International Health

Japan's Rohto Snaps Up TCM Specialist To Grow In Asia

In a deal worth around $600m, Rohto Pharmaceutical is poised to expand its dietary supplements offering in Southeast Asia through the acquisition of a controlling stake in Singapore's Eu Yan Sang.

Deals Asia Pacific

Karo Expands Intimate Health Offering With Bayer's Proctosedyl

Sweden's Karo has struck its second deal in six months bringing in the Proctosedyl hemorrhoid brand from Bayer.

Deals OTC Drugs
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Latest From Business Strategies & Health

Over The Counter: Solving The Sustainable Pill Pack Puzzle, With PA Consulting’s Tony Perrotta

In this episode of the updated Over The Counter podcast, HBW Insight speaks to sustainable packaging expert Tony Perrotta about the complexities of replacing plastic pill packs in medicines packaging. Perrotta is a partner at PA Consulting, which set up the Blister Pack Collective alongside consumer health players Haleon, Bayer and Sanofi. They are working with PulPac, which has invented a dry molded fiber alternative to plastic, which the Collective hopes to commercialize within 12-24 months. We discuss whether regulators will accept such alternatives, given the safety and stability requirements for medicines, and the challenges of recycling, given the multitude of different frameworks and processes across the world. Perrotta also reveals that one of the partners in PA Consulting’s Bottle Collective, which hopes to replace plastic bottles in the food, personal care and consumer health industries, will soon launch its first market trial.

International Health

Kenvue Cutting Staff 4% After Year Apart From J&J

Along with latest results, Kenvue says as its “transitions services agreement” with J&J ends, its board approves reducing global workforce by around 4%. It expects around $275m in pre-tax restructuring costs in both 2024 and 2025 without changes to its capital allocation priorities.

Sales & Earnings Consumer

People On The Move: Appointments At Haleon, Bayer, Abdi Ibrahim

A round-up of the latest European consumer health appointments: Haleon hires new CFO; Bayer Vital names new chief; Abdi Ibrahim appoints consumer health head.

Europe Executive Changes
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Latest From Sales & Earnings & Health

Opill Launch Delivers For Perrigo While Growing Pains Slow Overall First-Quarter Results

Perrigo spares little about Opill’s launch, advertising and outlook in Q1 earnings briefing, but management also makes clear it’s a large firm and some other segments of its global consumer health products business are holding back overall results.

Sales & Earnings Women's Health

Kenvue Cutting Staff 4% After Year Apart From J&J

Along with latest results, Kenvue says as its “transitions services agreement” with J&J ends, its board approves reducing global workforce by around 4%. It expects around $275m in pre-tax restructuring costs in both 2024 and 2025 without changes to its capital allocation priorities.

Sales & Earnings Consumer

Bausch + Lomb’s Prescription For Consumer Health Sales Growth Includes ‘Benefit’ From Rx Drugs

Blink NutriTears supplement containing lutein/zeaxanthin, curcumin and vitamin D3 coming in 2024 is example of a cross-segment sales benefit B+L sees in dry eye product category. Consumer eye care and vision health product sales are key drivers for 18% Q1 net sales growth to $1.1bn.

Consumer Sales & Earnings
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Latest From Legal Issues & Health

L’Oreal Joins J&J And Major Retailers Defending Benzene Class Actions In Federal Courts

Benzoyl peroxide-based acne drug products and their alleged proclivity to become contaminated with carcinogenic benzene are at the center of putative class actions filing against L’Oreal in federal courts around the US.

Legal Issues Ingredients

Cue The Class Actions! Plaintiffs React To Valisure’s Benzene Findings In Acne Drug Products

J&J, Target and Walgreens face class action complaints in California federal courts for economic harms caused by their sale of benzoyl peroxide-containing acne treatments, following Valisure’s 5 March citizen petition to the US FDA on findings of high levels of benzene in such products.

Ingredients Legal Issues

US FDA Should Reload Field Force To Target OTC Adulteration, Former Chief Counsel Hutt Says

Habitually noncompliant companies are laughing at FDA, Peter Barton Hutt says.

FDA Enforcement
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Marketing Explore this Topic

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Latest From Launches & Health

Opill Launch Delivers For Perrigo While Growing Pains Slow Overall First-Quarter Results

Perrigo spares little about Opill’s launch, advertising and outlook in Q1 earnings briefing, but management also makes clear it’s a large firm and some other segments of its global consumer health products business are holding back overall results.

Sales & Earnings Women's Health

Bausch + Lomb’s Prescription For Consumer Health Sales Growth Includes ‘Benefit’ From Rx Drugs

Blink NutriTears supplement containing lutein/zeaxanthin, curcumin and vitamin D3 coming in 2024 is example of a cross-segment sales benefit B+L sees in dry eye product category. Consumer eye care and vision health product sales are key drivers for 18% Q1 net sales growth to $1.1bn.

Consumer Sales & Earnings

OTC Marketing Awards 2024 Now Open For Entries

Returning for its 29th year, the Oscars of the OTC industry is now inviting entries from UK consumer health players across 12 categories.

Innovation Ad Campaigns
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Latest From Ad Campaigns & Health

OTC Marketing Awards 2024 Now Open For Entries

Returning for its 29th year, the Oscars of the OTC industry is now inviting entries from UK consumer health players across 12 categories.

Innovation Ad Campaigns

Federal Judge Knows ‘Clear’ When He Reads It

The regulation “is clear, as is the Court’s order” rejecting CRN’s motion for preliminary injunction against imposition of the regulation, says US district Judge Andrew Carter in order denying the trade group’s request for clarification of New York regulation.

Litigation Dietary Supplements

Maxwellia Delivers Two UK Menstrual Health Rx-To-OTC Switches

UK switch specialist Maxwellia delivers two “me too” reclassifications in the area of women's health: Evana Heavy Period Relief and Ultravana Period Pain Relief. 

United Kingdom Health
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Latest From Ad Complaints & Health

EU Firms To Pre-Approve Green Claims Or Face Minimum 4% Annual Turnover Fine

Exclusion from procurement processes, confiscation of revenues, and a fine of at least 4% of annual turnover are some of the penalties the European Parliament is considering for greenwashing as part of its position on the EU Green Claims Directive. 

Europe Health

Take Care With ‘Health Lite’ Claims

Some advertisers try to avoid scrutiny of regulators and the National Advertising Division when making health-related claims by making a claim “softer.” Annie Ugurlayan, NAD’s assistant director, offers advice on assuring substantiation and a health claim match.

Ad Complaints Dietary Supplements

ASA Files: How Not To Advertise A Digital Health App In The UK

ADHD-management software Happyo falls foul of UK advertising rules in a recent ASA case. The lesson: if in the UK the intended use of a digital health app is the diagnosis of a serious medical condition, supervision by a healthcare professional such as a doctor is likely to be necessary, in which case advertising to the public would also be prohibited.

United Kingdom Health
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