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Health (OTC Drugs)

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Regulation/Legislation Explore this Topic

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Latest From Regulation, Legislation & Health

First Final Guidance For Overhauled US OTC Monograph Program Covers Submitting Proposals

Publication of final guidance for industry on submitting change proposals and other requests using the only accepted format, electronic, leaves agency at four of the five required guidances it has provided on compliance with requirements of its streamlined OTC monograph process.

OTC Drugs Guidance Documents

PAGB: Labour Must Prioritize Self-Care In First 100 Days Of New UK Government

The UK's consumer healthcare industry association, PAGB, sets out six priorities for the new UK government, following the landslide victory of the Labour Party in the recent general election. One of these priorities is driving Rx-to-OTC switch - something that the UK public also wants, according to the association's latest Self-Care Census, published to mark International Self-Care Day 2024.

United Kingdom Health

US Consumer Health Q2 Earnings Preview: If Not For Headwinds, Tailwinds Would Be Trending

Analysts tracking consumer health product firms in the US anticipatevApril-June results lower than a year ago across most businesses. While some results will be lower on comparisons with strong growth in 2023, others will reflect a slow allergy season, retailers’ inventories remaining high as consumer spending slows or firms continuing to recover from supply chain problems.

Consumer Business Strategies

Chevron Deference Muted, Higher Volume Ahead For US Supplement Market Regulatory Questions

Attorneys discuss potential impacts on consumer health products industry from Supreme Court’s “Loper Bright” decision in June on litigation brought by two fisheries, Loper Bright v. Raimondo and Relentless v. Department of Commerce.

FDA Litigation

Chevron’s Fall Strengthens Industry’s Hand In Disagreements With US FDA, But May Spur Delays

Firms can be more forceful in disputes with FDA now that Supreme Court has eliminated Chevron deference. Questions around whether an evidentiary standard has been met may be ripe for challenge, legal experts said, but they also caution that sponsors will face more uncertainty.

Legal Issues FDA

GuruNanda’s ‘Reverse Cavities’ Claims On Coconut Oil Rinse Meet NAD SWIFT Review

Oral Essentials filed a Fast-Track SWIFT review case with the National Advertising Division against competitor GuruNanda LLC, whose endorsers claimed its pulling oil could reverse cavities. The marketer agreed to ensure that claims in question were discontinued.

Regulation Advertising, Marketing & Sales
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Business Explore this Topic

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Latest From Deals & Health

US Consumer Health Q2 Earnings Preview: If Not For Headwinds, Tailwinds Would Be Trending

Analysts tracking consumer health product firms in the US anticipatevApril-June results lower than a year ago across most businesses. While some results will be lower on comparisons with strong growth in 2023, others will reflect a slow allergy season, retailers’ inventories remaining high as consumer spending slows or firms continuing to recover from supply chain problems.

Consumer Business Strategies

Cooper Completes Viatris Deal After Agreeing To Offload Brands

Cooper Consumer Health has closed its acquisition of Viatris' OTC business as it commits to divesting the rights to infant laxative medicine Bebegel and earwax removal product Otowaxol in certain markets.

Deals Europe

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

The Indian player made another high-level deal that grants it rights to nicotine replacement therapies in over 30 countries, following on from its recent announcements with Nestlé.

OTC Drugs Deals
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Latest From Business Strategies & Health

Sanofi In Midst Of ‘Very Competitive Process’ For Consumer Business

“The game is still totally open,” said Sanofi CFO François-Xavier Roger in response to questions about how the company intends to separate its Consumer Healthcare business. The comments came as Sanofi reported its Q2 results.

Business Strategies Sales & Earnings

Reckitt Shakes Up Consumer Health Organization As It Narrows Group Focus

Reckitt has designated its Mead Johnson infant nutrition and home care businesses as non-core operations. The company will now reorganize to sharpen its focus on the consumer health and hygiene markets in the pursuit of sustainable, long-term growth.

Business Strategies OTC Drugs

People On The Move: Appointments At Perrigo, European Commission, EFSA

A round-up of the latest appointments in Europe's health and wellness industries: Perrigo makes management changes; European Commission president re-elected; EFSA appoints new members to scientific panels.

Executive Changes Leadership
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Latest From Sales & Earnings & Health

Sanofi In Midst Of ‘Very Competitive Process’ For Consumer Business

“The game is still totally open,” said Sanofi CFO François-Xavier Roger in response to questions about how the company intends to separate its Consumer Healthcare business. The comments came as Sanofi reported its Q2 results.

Business Strategies Sales & Earnings

Reckitt Shakes Up Consumer Health Organization As It Narrows Group Focus

Reckitt has designated its Mead Johnson infant nutrition and home care businesses as non-core operations. The company will now reorganize to sharpen its focus on the consumer health and hygiene markets in the pursuit of sustainable, long-term growth.

Business Strategies OTC Drugs

US Consumer Health Q2 Earnings Preview: If Not For Headwinds, Tailwinds Would Be Trending

Analysts tracking consumer health product firms in the US anticipatevApril-June results lower than a year ago across most businesses. While some results will be lower on comparisons with strong growth in 2023, others will reflect a slow allergy season, retailers’ inventories remaining high as consumer spending slows or firms continuing to recover from supply chain problems.

Consumer Business Strategies
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Latest From Legal Issues & Health

Chevron’s Fall Strengthens Industry’s Hand In Disagreements With US FDA, But May Spur Delays

Firms can be more forceful in disputes with FDA now that Supreme Court has eliminated Chevron deference. Questions around whether an evidentiary standard has been met may be ripe for challenge, legal experts said, but they also caution that sponsors will face more uncertainty.

Legal Issues FDA

Deference No More: More Challenges Against US FDA After Supreme Court Tosses Chevron Doctrine?

The Supreme Court’s 6-3 ruling is expected to have a minimal impact on drug approvals and other scientific determinations, but matters steeped in the interpretation of regulation and statute, such as marketing exclusivity, could face a heightened risk of challenge, legal experts say.

Legal Issues FDA

Supreme Court Mifepristone Decision Sets High Bar For FDA Suits, But Risks To Agency Authority Linger

The unanimous decision that the Alliance for Hippocratic Medicine lacks standing to challenge the FDA’s relaxation of the abortion pill REMS leaves unclear whether the court would have deferred to the agency’s expertise on the merits. 

Women's Health Litigation
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Marketing Explore this Topic

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Latest From Launches & Health

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.

Germany Health

Safety Shot Shoots To Lead Hangover Remedy Market By Reducing ‘Blood Alcohol Content'

Analysts suggest more and larger investments than president’s recent $1m and $5m private placements needed to last long enough to establish sales of its functional beverage sufficient to turn a profit. Results expected soon from clinical trials on “detoxifying the alcohol out of” users’ bodies.

Consumer Launches

Stada Strikes Deal To Expand Middle East And Africa OTC Portfolio

A deal between Stada Arzneimittel and Adcan Pharma will see the former exclusively market and commercialize in the UAE a portfolio of 15 consumer healthcare products produced and supplied by the latter.

Middle East and Africa United Arab Emirates
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Latest From Ad Campaigns & Health

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.

Germany Health

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

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.

Europe Health
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Latest From Ad Complaints & Health

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.

Europe Health

ASA Files: Denigrating Competitors ‘Isn’t A Good Look’ For Advertisers

Bayer Consumer Health and its effervescent vitamin brand Berocca were subjects of denigratory remarks by an online competitor in a recent UK advertising complaint ruling. The ASA’s Freddie Alcock talks HBW Insight through the complaint, explaining in this exclusive interview why denigration is never a good look for advertisers.

United Kingdom Health

ASA Files: It’s Not Just What You Say, But How You Say It

Infirst has been admonished by UK ad authority, ASA, for implying in a TV commercial its lipid-based ibuprofen brand Flarin was more, or uniquely, effective for joint pain relief than other forms of ibuprofen.

United Kingdom Health
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