Women's Health

CEO Bill Anderson would not be drawn on whether the drug, currently approved for chronic kidney disease associated with type 2 diabetes, will hit a previous forecast of €3bn peak sales, but expansion into heart failure may make that figure look conservative.

This week, Neuralink announced it received US FDA breakthrough device designation for a device to restore sight; medtechs Discure and DeepLook secured new funding; FDA pump recalls from B. Braun Medical and Fresenius Kabi; Axonics prevails in patent infringement lawsuit with Medtronic; Merit Medical buys Cook Medical for $210m.

The US FDA updated labeling for Astellas’ drug for hot flashes after a postmarketing report of a single patient with signs and symptoms of liver injury taking the medicine. 

Height of plaintiff attorney’s argument to present evidence which would prompt speculation by a jury was request to parse research by Kenvue’s lead expert, who coordinated the International Consensus Statement on ADHD by the World Federation of ADHD, where he’s president.

WishGarden Herbs marks 45 years with line extensions; Obesity doctor develops SoWell supplements for GLP-1 patients; Vital Proteins makes sustainability vital in packaging; and interior decoration and rent awards in vitaminwater campaign.

The recent Women in Advanced Therapies Global event, delivered via an interactive 24-hour platform, hosted a number of biopharma speakers who drew on personal and industry-wide experiences, all aligned by a desire to break biases.

The firm’s development of VagiBiom prebiotic and probiotic supplements and suppositories and Vee feminine health tracking app emanated from founder Bobban Subhadra’s interest in the health potential of the human microbiome and research in the fields of microbiology and immunology.

Consumer health, particularly food supplements that make unauthorized medical or health claims, has been a key area of focus for the UK Advertising Standards Authority's recently introduced Active Ad Monitoring system, which captures ads by relevant advertisers from a range of social media platforms, and applies machine learning algorithms to identify and flag likely non-compliant ads, which are then sent to experts to review and act on. This infographic highlights recent ASA rulings against ads for supplements claiming to treat anxiety and stress, menopause, autism/ADHD and weight loss, which were flagged by AI.

Unauthorized medical or health claims for dietary supplements are a key focus area for the UK advertising regulator's new AI-powered Active Ad monitoring system. HBW Insight speaks to the ASA’s head of data science, Adam Davison, in this exclusive interview to find out more about the organization's journey towards pre-emptive regulation. 

OTC private label/store brand product giant’s Q2 net sales down 10.7% to $1.1bn, but women’s health product sales jump 31.4% largely on Opill launched late in Q1. Biggest hit to results from infant formula business, down a reported 82% due to ongoing manufacturing quality-control remediation.

As sales of the Japanese drugmaker’s non-hormonal treatment for menopausal symptoms Veozah finally take off, the German major has filed its potential competitor, elinzanetant, with the US Food and Drug Administration.

Medway NHS Foundation Trust joined forces with Digostics to offer home oral glucose tolerance testing for pregnant women at risk of gestational diabetes. 

While its European licensee is preparing for an imminent launch, Kissei has also been expanding its partnerships in Asia for female health product linzagolix. A new alliance is also being sought in the US to assist with a new trial and NDA refiling there.

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.

A Trump-aligned think tank doesn’t have too much to say about the US FDA – which is probably a good thing for the agency. But it does reinforce the reality that abortion politics will continue to impact the agency – and that ties to industry may be a bipartisan area of concern.

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.

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.

Consumer health companies need to meet consumers where they are in their life-stage journeys, providing healthy aging solutions like dietary supplements that have clearly communicated and science-backed benefits, argued panelists at a recent IQVIA Consumer Health webinar. This is particularly the case for women, who are underserved and want natural support for changes like the menopause, said Haleon's Sheryl Tan. 

UK medical devices manufacturer Owen Mumford moves into consumer health with umbrella brand Clariti and OTC relaunch of at-home vaginismus and dyspareunia treatment Amielle Comfort.

UK medical devices manufacturer Owen Mumford moves into consumer health with umbrella brand Clariti and OTC relaunch of at-home vaginismus and dyspareunia treatment Amielle Comfort.