International

US Proposal To Remove Phenylephrine From OTC Monograph Could Stress-Test Streamlined Process

US Proposal To Remove Phenylephrine From OTC Monograph Could Stress-Test Streamlined Process

 

Proposed administrative order likely is first to prompt opposition from OTC industry or other stakeholders potentially delaying or deferring the agency’s expectation for moving its proposal to a deemed final order effective one year after it would be published.

Haleon Talks Up China Strength As Investment Grows

Haleon Talks Up China Strength As Investment Grows

 
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Haleon highlighted consistent market share gains in China as it reported third-quarter results.

Sanofi Clarifies Bpifrance's Role In Opella Deal

Sanofi Clarifies Bpifrance's Role In Opella Deal

 
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French public sector investment bank Bpifrance's influence over the future strategy of Opella extends to its one seat on the company's board, but not past that, Sanofi confirms as it reports Q3 results.

Reckitt Promises ‘Big’ Q4 As Consumer Health Market Share Rebounds

Reckitt Promises ‘Big’ Q4 As Consumer Health Market Share Rebounds

 
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A better than expected showing from its Health business in its latest quarter has teed up Reckitt for a big finish to the year.


FDA Clears Qnovia’s NRT Inhalation IND, Commits To ‘Stimulating’ Smoking Cessation Innovation

FDA Clears Qnovia’s NRT Inhalation IND, Commits To ‘Stimulating’ Smoking Cessation Innovation

 

Qnovia notes NRT inhalation product recently received investigational new drug clearance from FDA as agency and NIH say innovation needed smoking cessation to help improve rate of success for quitting the habit that kills around 500,000 US consumers annually.

US Nutrition Market People News: CRN/Radicle Award, Nourish, VSI, LabConnect, Akita, More

US Nutrition Market People News: CRN/Radicle Award, Nourish, VSI, LabConnect, Akita, More

 

CRN/Radicle Trailblazing Woman Award to ChromaDex’s Yasmeen Nkrumah-Elie; Nourish’s TV ad campaign features US soccer star Alex Morgan; Vitamin Shoppe BodyTech Elite Altered Strength line sponsors Team Red, White & Blues; contract pharma/consumer health product development firm LabConnect appoints Wesley Wheeler CEO; Avanos’ Game Ready is “Recovery Partner” of NFL’s Nick Bosa; Akita adds Robert Hanson to advisory board; and BODi has wrestler as brand ambassador

GSK Tab To Clear Zantac Litigation Ledger Of 93% Of Complaints Pending In State Courts: $2.2Bn

GSK Tab To Clear Zantac Litigation Ledger Of 93% Of Complaints Pending In State Courts: $2.2Bn

 

UK pharma also reaches agreement in principle, subject to DoJ approval, to pay $70m to resolve a whistleblower complaint filed by Valisure, the testing lab which in 2019 raised concerns about a potential link between the use of drugs containing ranitidine, a histamine-2 blocker, and cancer.

FDA Workshop To Consider Pediatric Research Rules Compliance By OTCs Available Through NDAs

FDA Workshop To Consider Pediatric Research Rules Compliance By OTCs Available Through NDAs

 

NDAs for additional OTC products containing acetaminophen and/or NSAIDs and indicated for use by children between 2 and less than 12 years old would trigger compliance by application sponsors with the act passed in 2003 to address lack of pediatric use information in drug labeling.


Country Life Vitamins Surveys Consumers About Healthy Aging For Ageless Theory Line Launch

Country Life Vitamins Surveys Consumers About Healthy Aging For Ageless Theory Line Launch

 

Country Life Vitamins launches healthy aging support line as it announces less than half of US consumers in a recent survey were aware of biological processes that affect aging. Groupe Berken and Arctic Biosciences partner to bring to North America herring caviar oil extract in a supplement designed to support optimal health across all life stages.

Nozzle At Tip Of Problems For Florida Eye Drop Firm: US FDA Warns Of GMP, Monograph Violations

Nozzle At Tip Of Problems For Florida Eye Drop Firm: US FDA Warns Of GMP, Monograph Violations

 

Regenerative Processing replaces nozzle to prevent backflow for its Regener-Eyes drops but FDA warning states numerous questions about sterility at the firm’s plant and about its procedures and systems for preventing microbial contamination.

‘The Possibilities Are Limitless’ – How Bayer CH Is Using AI To Drive Internal Efficiency

‘The Possibilities Are Limitless’ – How Bayer CH Is Using AI To Drive Internal Efficiency

 
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In addition to its recently established Precision Health division, Bayer Consumer Health is using artificial intelligence to save time on routine tasks and to manage supply and demand, the firm’s head of digital transformation and IT, Cristina Nitulescu, tells HBW Insight.

OcuSoft Retains Retaine Brand Name, Looks Askance At Eyeleve Marketer’s Reference

OcuSoft Retains Retaine Brand Name, Looks Askance At Eyeleve Marketer’s Reference

 

After launching Retaine MGD Advanced, OcuSoft says a release by Bruder Healthcare referenced Retaine MGD trademark and statements from a previous OcuSoft announcement about the original product attributed to an optometrist. B+L, Rohto brand and homeopathic firm Relief Products also make US OTC eye care space moves.


Perelel Adds Women’s Health Education Platform, Plum Debuts With Vaginal Area Dryness Serum

Perelel Adds Women’s Health Education Platform, Plum Debuts With Vaginal Area Dryness Serum

 

Perelel acquiring Loom online platform providing reproductive health, sexual wellness and parenting education. First direct-to-consumer product for Curive Healthcare’s Plum brand formulated for vaginal area dryness.

Senate Hemp Regulation Bill’s Broad Prohibition On Synthetics In Supplements Has Industry Attention

Senate Hemp Regulation Bill’s Broad Prohibition On Synthetics In Supplements Has Industry Attention

 

Provision in Wyden and Merkley’s “Cannabinoid Safety and Regulation Act” referencing FDA authority outside hemp-derived ingredients could provide agency with needed authority to force from the market products labeled as supplements but containing drugs or eliminate the use of many safe ingredients in supplements.

Edgewell Stirs Leadership, Brewing Industry Veteran Executive Leads North America Business

Edgewell Stirs Leadership, Brewing Industry Veteran Executive Leads North America Business

 

Jessica Spence joins as North American president while CFO Dan Sullivan becomes COO and Francesca Weissman, finance and business strategy SVP, adds CFO to her title in latest executive office changes by the marketer of brands including Schick men's and women’s shaving, Playtex, Stayfree, Carefree and o.b. feminine care and Banana Boat and Hawaiian Tropic sun care.

Reporting Problems To US FDA Simplified After Delayed Response To Formula Plant Complaint

Reporting Problems To US FDA Simplified After Delayed Response To Formula Plant Complaint

 

Streamlined process for reporting problems is key piece of “unified Human Foods Program” which officially launched on 1 October, as Commissioner Robert Califf says, “a new model for field operations and other modernization efforts.”


US FDA Forecasts Monograph Program Activities As Overhaul Transitions From Construction Phase

US FDA Forecasts Monograph Program Activities As Overhaul Transitions From Construction Phase

 

Nonbinding forecast, fourth for the program, includes risks associated with codeine-containing cough medicine as a topic FDA will include in ongoing evaluation of GRASE for pediatric cough cold drug products marketed under monograph for cold, cough, allergy, bronchodilator and anti-asthmatic OTC drugs.

US Formula Market Astir With Changes As Congress Stirs Tighter Product Quality Regulations

US Formula Market Astir With Changes As Congress Stirs Tighter Product Quality Regulations

 

Brands also making market moves as lawmakers consider legislation instructing Transportation Security Administration to provide guidance to minimize risk for contamination of baby formula and related pediatric nutritional products.

Mucinex Brand Enters Drug-Free Space With Saline Nasal Spray Featuring Dual Nozzles

Mucinex Brand Enters Drug-Free Space With Saline Nasal Spray Featuring Dual Nozzles

 

Mucinex Sinus saline nasal spray is designed to treat sinus-related symptoms as “first-ever drug-free saline product” with a dual nozzle offering two spray settings, marketer Reckitt-Benckiser says.

US Consumer Health Market People News: WishGarden, ChromaDex, Vivazen, More

US Consumer Health Market People News: WishGarden, ChromaDex, Vivazen, More

 

Liquid herbal blends firm WishGarden Herbs expands its leadership with three hires; ChromaDex appoints Ozan Pamir CFO; Vivazen adds CMO; Post Malone promotes poppi; and marketing consultant Gould gets ‘Most Influential’ nod.