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Digital Health & AI

Set Alert for Digital Health

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Draft guidance will offer a risk-based framework for accessing the credibility of AI and help ensure that AI models used to answer regulatory questions are sufficiently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.

Artificial Intelligence Guidance Documents

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.

Europe International

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.

E-Commerce Advertising, Marketing & Sales

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.

Dietary Supplements Deals

‘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.

Digital Health Artificial Intelligence

AESGP Publishes Guidance For EU Companies Advertising Self-Care Products Online

When it comes to online consumer health product advertising, complying with regulations, ensuring that content is factually correct and being transparent are some of the key principles that companies should adhere to, recommends AESGP in a recently published position paper. 

Europe Health

AI Act: How To Preserve EU’s Industrial Competitiveness Through Proportionate Regulation

The AI medtech revolution could be a “huge, missed opportunity” for the EU without an effective and efficient regulatory infrastructure. Answers are needed fast, MedTech Europe’s Oliver Bisazza said during a recent interview.

Europe EU

Click Therapeutics Anticipates Pharma Will Begin Developing Digital Drugs From Clinical Stage

Leading digital therapeutic maker’s CEO David Benshoof Klein and CMO Shaheen Lakhan discuss outlook on the DTx space, priorities going forward, and what makes Click a standout player in a changing game.

Digital Health Business Strategies

AESGP Meeting: Real World Evidence Could Drive Rx-To-OTC Switch, If Regulators Embrace It

Real-world data and evidence, for example generated by digital consumer health technology like apps and wearables, could provide crucial support for Rx-to-OTC switch applications, argues Sanofi Consumer Healthcare’s Penny Glover at the Association of the European Self-Care Industry's 60th Annual Meeting in Brussels, Belgium. Recent research by Sanofi indicates that regulators are actually already using RWD and RWE in many cases when assessing switch applications, even if they do not call it that. 

International Health

CARU Puts Brands On Notice: Guidelines For Children’s Advertising Extend To AI

The BBB National Programs, Inc.’s Children’s Advertising Review Unit reminds advertisers its Advertising and Privacy Guidelines extend to the use of AI in ads for children and points them to its recent warning that it will ‘strictly enforce’ those guidelines.

US States Beauty

AESGP Annual Meeting: OTC Firms Must ‘Innovate Harder’ To Realize Growth Opportunity

Industry can look forward to a global OTC market compound annual growth rate of around 7% over the next few years, according to IQVIA Consumer Health. Innovation will be key to ensure individual companies realize this level of growth. IQVIA CH's Amit Shukla and Simon-Kucher & Partners' Clemens Oberhammer point to some key consumer trends to keep an eye on at the recent AESGP Annual Meeting in Brussels. 

International Health

AESGP Meeting: Climate Inaction Could Cost Healthcare Companies 10-20% Operating Profit

Failing to take sufficient action on climate change could be a costly business for consumer health companies. However, the good news from the AESGP's 60th Annual Meeting in Brussels, Belgium, is that at least half of the cost of decarbonizing will be balanced by savings, according to Boston Consulting Group. And climate change adaption will present firms with a wide variety of opportunities for product innovation, IQVIA Consumer Health's Volker Spitzer tells delegates.

International Health

Herbalife Opens Direct Lines To President, Recalculates On Marketing To GLP-1 Patients

During recent investor conference, president Stephan Gratziani and CFO John DeSimone discuss Herbalife’s restructuring in addition to progress on digital transformation program and lack of progress on expectations for marketing to consumers prescribed GLP-1 drugs for weight loss.

Dietary Supplements Restructuring

Food Additive Group Says US FDA NDIN Draft Guidance Leaves Master File ‘Necessity Unclear’

International Food Additives Council suggests master file system will be redundant to submitting NDINs required for some dietary ingredients. IFAC also asks FDA to clarify whether the history of a substance’s use in food “is at the strain level or species level.”

Dietary Supplements FDA

CHPA, CRN Remind US FDA About Enforcement In Comments On NDIN Master File Draft Guidance

CRN is “disappointed the draft guidance was not accompanied with an announcement by FDA of its commitment to rigorously enforce the NDI notification requirement.” CHPA says NDIN “requirement is only meaningful if FDA consistently takes enforcement action against manufacturers and distributors” noncompliant with the requirement.

Dietary Supplements Guidance Documents

US Consumer Health Sector Seizing Opportunity To Market Products, Services To GLP-1 Patients

Latest moves on selling to consumers using GLP-1 receptor agonist drugs for obesity come from firms as large as global food products manufacturer and marketer Nestle and as small as startup Promino and as ambitious as men’s health product marketer Ro offering an app at no charge to find GLP-1 drugs.

Consumer Launches