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Featured Stories

Like ‘Natural’ And ‘Clean,’ Personal-Care Brands Must Be Prepared To Defend ‘Simple’ Claims

Clasado Leaning Into APAC Gut Health Trend With China Distribution Deal

Dr Reddy’s Acquiring Haleon NRTs Available Outside US In Deal Worth Up To $632M

Spotlight On Sustainability

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

Latest Articles

Global Policy, Regulation & Law

Another Expert Fails Judge’s Review In Litigation Challenging OTC Acetaminophen Safety

Kenvue plans to ask judge to dismiss complaints relying on testimony from latest expert plaintiffs’ attorneys offered that prenatal use of Tylenol or other acetaminophen oral products is linked autism and ADHD in children. Judge previously dismissed complaints relying on five other experts’ testimony.

Closing Thoughts On US FDA Advisory Committee Reforms

One speaker at the US FDA’s day-long “listening session” on advisory committee reform captured an important truth: the problem is not necessarily how committees are run, it is that there are no alternatives for public input into agency decisions.

Proposal To Restrict Use Of Popular Supplement Ingredients In EU 'Highly Problematic'

FoodChain ID’s head of scientific affairs Jérôme Le Bloch discusses a proposal put to the European Commission by national food regulators to restrict on safety grounds the use of popular substances such as curcumin, melatonin and St John’s wort in supplements.

Congressional Appropriators Encourage FDA Guidance On Contraceptive OTC Switches

House and Senate reports again reference sunscreen but add admonishment that FDA “harmonize its approach with international testing standards.” Item exclusive to House report encourages guidance for drug firms on successfully submitting an application for Rx-to-OTC switch of an oral contraceptive.

Digital Health & AI

US FDA Guidance On Artificial Intelligence For Regulatory Decision-Making Expected This Year

Draft guidance will offer a risk-based framework for accessing the credibility of AI and help ensure that AI models used to answer regulatory questions are sufficiently credible for a particular ‘context of use,’ CDER’s Tala Fakhouri says.

Over The Counter: How To Innovate For The Ages, With Bayer’s Reese Fitzpatrick And Rachel Koontz

Aspirin is celebrating its 125th anniversary this year. To find out what brand owner Bayer Consumer Health is doing to celebrate this occasion, and what it is doing to take the brand into the next 125 years, HBW Insight chats with the company’s senior vice president, Global Head Allergy, Cough/Cold, Pain and Heart Health, Reese Fitzpatrick, and head of R&D, North America and Therapeutics, Rachel Koontz.

Estee Lauder Companies Has Opened Three Branded Storefronts On Amazon Since March

Bumble and bumble follows Too Faced and Clinique, also with their own storefronts within Amazon’s Premium Beauty space. Lauder notes the broader reach and the importance of meeting consumers where they already are shopping.

US Wellness Market Movers: Doctor’s Best, Society Brands, CharmHealth

Doctor's Best acquires Viactiv calcium and magnesium brand from Guardion; VitaliyNow is Society Brands’ third 2024 acquisition; and VitaminLab formulation services on CharmHealth.

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Sustainability

Over the Counter: EPR Consultant Urges Producers To Start Collecting Packaging Data

In this episode, HBW chats with Michael Washburn, principal at Washburn Consulting, on how producers of single-use packaging subject to extended producer responsibility laws rolling out in Oregon, Colorado and California next year can tackle the tedious work of collecting data on packaging materials. 

Grove Collaborative's New Impact Tracker Shows Customers Their Plastic Savings On Each Order

The plastic-neutral retailer of personal care, health and wellness, household cleaning and other sustainable products has been focused on enhancing its customer experience and expanding its third-party assortment as it progresses toward long-term, profitable growth. The company revealed on 1 July that it will not be Plastic-Free by 2025, but is on track to avoid 15 million pounds of plastic by 2030.

EU’s Historic PFAS Restriction Looms Over Life Sciences Industries

The European Chemicals Agency’s committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) are evaluating sector by sector the proposed REACH restriction on PFAS and more than 5,600 public comments, reaching provisional conclusions on cosmetics at their June meetings. A date has not been set to consider PFAS uses in medical devices, which are numerous, essential, and in many cases devoid of alternatives, industry says.

EU Green Claims Directive: Council Wants Lighter Touch, Especially For SMEs

The European Council adopts its negotiating position with regards to the Green Claims Directive, which aims to prevent greenwashing and empower consumers in making informed, environmentally conscious purchasing decisions. While small and medium-sized enterprises stand to specifically benefit from the Council's more flexible approach, companies in general may be allowed to make certain explicit environmental claims without third-party verification.

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Interviews

Proposal To Restrict Use Of Popular Supplement Ingredients In EU 'Highly Problematic'

FoodChain ID’s head of scientific affairs Jérôme Le Bloch discusses a proposal put to the European Commission by national food regulators to restrict on safety grounds the use of popular substances such as curcumin, melatonin and St John’s wort in supplements.

Over the Counter: EPR Consultant Urges Producers To Start Collecting Packaging Data

In this episode, HBW chats with Michael Washburn, principal at Washburn Consulting, on how producers of single-use packaging subject to extended producer responsibility laws rolling out in Oregon, Colorado and California next year can tackle the tedious work of collecting data on packaging materials. 

Over The Counter: How To Innovate For The Ages, With Bayer’s Reese Fitzpatrick And Rachel Koontz

Aspirin is celebrating its 125th anniversary this year. To find out what brand owner Bayer Consumer Health is doing to celebrate this occasion, and what it is doing to take the brand into the next 125 years, HBW Insight chats with the company’s senior vice president, Global Head Allergy, Cough/Cold, Pain and Heart Health, Reese Fitzpatrick, and head of R&D, North America and Therapeutics, Rachel Koontz.

‘Is This Doomsday Concern, Or Is It Reality?’ Verily CMO On AI’s Future, Lightpath Metabolic, More

Andrew Trister, Verily’s chief medical and scientific officer, discusses Verily’s newly launched Lightpath Metabolic solution, featuring GLP-1 prescription, AI and strengthened clinical support. Plus, the Google health tech spinout's plans for the Study Watch, the Alzheimer’s research landscape, and AI development and regulation in a new era of uncertainty.

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Recent Stories

Another Expert Fails Judge’s Review In Litigation Challenging OTC Acetaminophen Safety

Kenvue plans to ask judge to dismiss complaints relying on testimony from latest expert plaintiffs’ attorneys offered that prenatal use of Tylenol or other acetaminophen oral products is linked autism and ADHD in children. Judge previously dismissed complaints relying on five other experts’ testimony.

Closing Thoughts On US FDA Advisory Committee Reforms

One speaker at the US FDA’s day-long “listening session” on advisory committee reform captured an important truth: the problem is not necessarily how committees are run, it is that there are no alternatives for public input into agency decisions.

Proposal To Restrict Use Of Popular Supplement Ingredients In EU 'Highly Problematic'

FoodChain ID’s head of scientific affairs Jérôme Le Bloch discusses a proposal put to the European Commission by national food regulators to restrict on safety grounds the use of popular substances such as curcumin, melatonin and St John’s wort in supplements.

Congressional Appropriators Encourage FDA Guidance On Contraceptive OTC Switches

House and Senate reports again reference sunscreen but add admonishment that FDA “harmonize its approach with international testing standards.” Item exclusive to House report encourages guidance for drug firms on successfully submitting an application for Rx-to-OTC switch of an oral contraceptive.

Over the Counter: EPR Consultant Urges Producers To Start Collecting Packaging Data

In this episode, HBW chats with Michael Washburn, principal at Washburn Consulting, on how producers of single-use packaging subject to extended producer responsibility laws rolling out in Oregon, Colorado and California next year can tackle the tedious work of collecting data on packaging materials. 

EU Health Claim For Memory Loss Supplement Turned Down

The proposed EU health claim, “Citicoline intake supports memory function in healthy middle-aged and elderly persons encountering age-related memory impairment” has not been substantiated by the evidence submitted, according to the European Food Safety Authority.

FDA Request For Help On Hemp Regulation Gets Lower Profile In House Appropriators' Report

Committee’s report published with FY2025 appropriation states a different approach to establishing FDA regulation of non-drug products containing hemp as a derivative of cannabis de-scheduled as controlled substance in the US since 2018.

House Appropriators Develop Hazy Picture For Future Of US Hemp Products Industry

Industry expects instructions stated in committee’s report to counter an amendment included in the bill it passed by on 10 July which would define as controlled substances a majority of hemp ingredients currently available in supplements, food and non-drug topicals in the US.

PETA Challenges FDA 'Insistence' On Animal Testing For Sunscreen Products

Animal advocacy group PETA claims documents recently made public on listening sessions between the US Food and Drug Administration and sunscreen manufacturers show FDA is ‘checking a box by pushing decades-old animal tests rather than using modern science’ to assess the safety of sunscreens, despite the agency’s claims that it is encouraging non-animal methods.

Menopause And Women’s Health Prominent Among Recent German OTC Launches

Responding to demand from women for consumer health products that meet their specific needs, P&G and Pro Medico both launch hop-based supplements for menopause symptoms. Meanwhile, Bayer adds a hair mask to its Priorin range for women with female pattern hair loss and Klosterfrau expands its Femafriends brand with an intimate health gel.

Syphilis OTC Test Developer NOWDiagnostics Raises $22.5M

The Series B funding round led by DigitalDx Ventures will support development and commercialization of more than 30 rapid diagnostic tests in NOWDx’s clinical research pipeline, including its First To Know Syphilis OTC test, currently under US FDA De Novo review, which provides at-home results in minutes.

Reckitt Eyes Greater Slice Of China Market With R&D Center Investment

Reckitt is investing over $40m to build a dedicated Chinese R&D center of excellence in Shanghai as it looks to capitalize on the double-digit sales growth it has recorded in the world's most populous market over recent years.

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