Business


German Associations Call For EU Green Claims Directive Trilogue Suspension

 
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Pharma Deutschland is one of 21 German associations calling for trilogue negotiations in relation to the EU Green Claims Directive to be suspended while a “comprehensive and independent written impact assessment” is undertaken.

TheraBreath ‘Guarantee Better’ Claim Serious, Not Puffery With Founder Prominent In Advertising

 

Challenged advertising, which appeared in a TV commercial, in-store displays and advertising on social media, included express claims “It’s a better mouthwash. I guarantee it.” and “I guarantee it. – ‘Dr. Harold Katz.’”

US Consumer Health Sector Vigilant To Avoid Stumbling On Trump’s Tariff Twists And Turns

 

In remarks at recent investor conference reflecting comments from across the US consumer health sector, Kenvue chief Thibaut Mongon says, “I'm going to state the obvious. The environment is very fluid.”

AESGP Annual Meeting: Consumer Health Sector Still Safe Bet For Investors

 
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A healthy diversity of different types of players and plenty of space for scaling up are among the reasons that investors remain interested in the consumer health sector, according to investment bankers speaking at the recent AESGP Annual Meeting.

Innovation & IP


AESGP Annual Meeting: Commission Must ‘Think Carefully’ Before Reverse-Switching Antimicrobials

 
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If the European Commission is serious about improving the competitiveness of the European Union, it should ditch the idea of making commonly used OTC antimicrobials like thrush treatments and cold sore creams prescription-only, warns Greek Medicines Agency president Evangelos Manolopoulos

Review Suggests Advantage Of Bayer’s Iberogast Advance For Digestive Disorders

 
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Bayer's Iberogast Advance's combination of six herbal ingredients may produce a synergistic effect that acts on multiple underlying issues contributing to digestive disorders like functional dyspepsia (FD) and irritable bowel syndrome (IBS), a recently published study suggests.

OTC Marketing Awards 2025 Open For Entries

 
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Find out how to enter the OTC Marketing Awards before the 1 September entry deadline.

Over The Counter: Taking Real-World Evidence Seriously, With IQVIA Consumer Health’s Volker Spitzer

 
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In part 2 of HBW Insight's interview, IQVIA Consumer Health's vice president of global research and development and real-world evidence services, Volker Spitzer, explains how to approach real world evidence so that regulators recognize its validity, in supporting Rx-to-OTC switch applications, for example.

Policy & Regulation


FDA Takes World Tour In Recent OTC Warnings

 

FDA Center for Drug Evaluation and Research Office of Manufacturing Quality, Office of Compliance and Office of Unapproved Drugs & Labeling Compliance recently advise Indian, Canadian and US firms about GMP problems.

German Associations Call For EU Green Claims Directive Trilogue Suspension

 
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Pharma Deutschland is one of 21 German associations calling for trilogue negotiations in relation to the EU Green Claims Directive to be suspended while a “comprehensive and independent written impact assessment” is undertaken.

Over The Counter: EU Omnibus And ESG, What You Need To Know, With CEN Group’s Jasper Crone

 
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HBW Insight catches up with sustainability expert Jasper Crone to find out what consumer health companies need to know about the European Commission's Omnibus simplification package.

US FDA May Consolidate Support Services After Extensive Cuts

 

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.

Rx-to-OTC Switch


EU Pharma Reform: Council Proposes Rx Exemption For Topical Antimicrobials

 
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The EU Council has introduced a key amendment to Article 51 (para 1, point e) of the new pharma directive: “A medicinal product shall be subject to medical prescription where it is an antimicrobial, unless intended for topical use.”

AESGP Annual Meeting: Commission Must ‘Think Carefully’ Before Reverse-Switching Antimicrobials

 
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If the European Commission is serious about improving the competitiveness of the European Union, it should ditch the idea of making commonly used OTC antimicrobials like thrush treatments and cold sore creams prescription-only, warns Greek Medicines Agency president Evangelos Manolopoulos

Over The Counter: Driving Innovation In France’s Self-Care Market, With NèreS’ Luc Besançon

 
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HBW Insight speaks to NèreS' executive director Luc Besançon about the key issues facing France's self-care industry, especially Rx-to-OTC switch and the revised Urban Wastewater Treatment Directive.

Allergy Ingredient Itch Warning, ACNU Final Rule Scratch Extent Of FDA Authority For Label Changes

 

Effective date for ACNU OTC switch final rule and finding of severe itching from long-term use of common allergy ingredients are bookends for limits of FDA’s authority for product label changes.