News
HRT maker censured by regulators for ‘systemic failures’ that risked patient safety
Theramex has been censured over HRT failures that regulators said jeopardised patient safety.
The UK producer of HRT drugs, including Evorel and Intrarosa, was found to have breached fundamental compliance standards.
These included not updating crucial prescribing information, in some cases for several years, and not making clear that one drug must not be used during pregnancy.
The Prescription Medicines Code of Practice Authority issued the public reprimand after Theramex staff blew the whistle over what it described as “alarming” compliance issues and incomplete prescribing information for Evorel and Intrarosa that “jeopardise patient safety”.
Evorel patches, which contain estradiol, are among the most prescribed forms of transdermal HRT, meaning hormone treatment delivered through the skin. More than 250,000 items were issued in the last financial year, according to NHS Business Services Authority figures.
Overall, nearly 10m items of estradiol, including gels, were prescribed in the 2024/25 financial year.
The employees’ concerns included failing to provide comprehensive side-effect information in Evorel’s prescribing information, and not updating Intrarosa’s product information since 2019.
The PMCPA also reprimanded the company over failures to specify in advertising at a reproduction and advertising conference that Yselty, used to treat uterine fibroids, should not be taken during pregnancy.
In total, the PMCPA found Theramex had breached the Association of the British Pharmaceutical Industry’s code of practice 21 times.
The panel said the breaches not only jeopardised patient safety, but that Theramex had “brought discredit upon, and reduced confidence in, the pharmaceutical industry”.
The PMCPA also condemned Theramex’s decision to leave the regulator’s jurisdiction.
“By leaving the self-regulatory framework and requiring the Medicines and Healthcare products Regulatory Agency to assume full responsibility for regulating it, Theramex has inevitably delayed any regulatory action and oversight,” it said.
Dr Amit Aggarwal, medical director of the ABPI, said: “Theramex has fallen seriously short of the standards expected under our strict ABPI code of practice, and it’s right that the PMCPA took action.
“It’s also disappointing that as a result, the company has decided to leave the pharmaceutical industry’s self-regulatory system, which holds companies to standards above and beyond the law.”
Julian Beach, MHRA’s executive director of healthcare quality and access, said he was disappointed Theramex had left the PMCPA, but that the MHRA would take any necessary steps to ensure patient safety.
He said: “Leaving the jurisdiction of the PMCPA does not mean a company escapes scrutiny.
“The MHRA has legal powers to investigate and act on concerns about medicines that may impact public safety. Breaches of regulations can amount to criminal offences.”
A spokesperson for Theramex said: “Upholding ethical standards, compliance, and patient safety is very important to us. We acted promptly to address these historical matters as soon as we became aware of them.
“We take these matters seriously and have undertaken a comprehensive review of our compliance framework, including commissioning an independent external audit and implementing a broad programme of enhancements.
“As part of this process, we concluded it is most appropriate to be regulated with respect to UK medicines legislation by the MHRA, while continuing to uphold the spirit and principles of the EFPIA and ABPI codes of practice.
“Therefore, we withdrew from the PMCPA’s jurisdiction in January 2026. This approach allows us to focus our resources on maintaining high standards of ethical and compliant behaviour, with patient safety.”
Fertility
Future Fertility raises Series A financing to scale AI tools redefining fertility care worldwide
Future Fertility Inc. has announced the closing of a US$4.1 million Series A financing round.
The round was led by M Ventures (the corporate venture capital arm of Merck KGaA, Darmstadt, Germany) and Whitecap Venture Partners, with participation from new investors Sandpiper Ventures, Gaingels, and Jolt VC.
The financing will accelerate Future Fertility’s commercial expansion into Asia-Pacific and support its entry into the United States, including planned FDA 510(k) clearance for additional products as part of a broader U.S. market entry strategy.
Proceeds will also advance the development of a broader AI platform, from egg assessment through to embryo transfer, designed to support clinicians, embryologists, and patients across the full IVF journey.
M Ventures and Whitecap have supported Future Fertility’s mission to translate AI innovation into meaningful clinical outcomes since the company’s earliest stages.
Oliver Hardick, investment director, M Ventures, said: “Future Fertility is addressing a critical unmet need in reproductive medicine with a differentiated AI platform grounded in clinical data and real-world workflow integration.
“We are excited to continue supporting the company and team because we believe its technology has the potential to improve decision-making for clinicians, bring greater clarity to patients, and help advance a more personalised standard of care in fertility treatment.”
Future Fertility’s AI platform addresses a long-standing gap in fertility care: historically, there has been no objective, clinically validated method for assessing egg quality (Gardner et al., 2025), despite it being one of the most important drivers of reproductive success.
The company’s suite of deep learning tools includes VIOLET™, MAGENTA™, and ROSE™, purpose-built for egg freezing, IVF, and egg donation respectively.
The tools are based on AI models trained and validated on more than 650,000 oocyte images and are deployed in over 300 clinics across 35 countries.
Rhiannon Davies, founding and managing partner, Sandpiper Ventures, said: “The best outcomes in fertility care globally come from better data and smarter tools. Future Fertility understands that, and they’ve built a platform that delivers on it.
“Sandpiper is proud to back a team turning rigorous science into real results for patients and clinicians alike.”
Partnerships with the world’s leading fertility networks – including IVI RMA and Eugin Group across Latin America and Europe, FertGroup Medicina Reproductiva in Brazil, and most recently announced Kato Ladies Clinic in Japan – reflect growing demand for objective, AI-powered oocyte assessment in fertility care. In the United States, ROSE™ is newly available under an FDA 513(g) determination.
Research shows that approximately 50 per cent of IVF patients do not understand their likelihood of success, and many discontinue treatment prematurely, even though cumulative success rates improve significantly with multiple cycles (McMahon et al., 2024).
By delivering earlier clarity on egg quality, Future Fertility’s tools support more informed conversations between clinicians and patients, helping set realistic expectations and guide decisions about next steps.
Future Fertility’s growing evidence base spans seven peer-reviewed publications in Human Reproduction, Reproductive BioMedicine Online, Fertility & Sterility, and Nature’s Scientific Reports, and more than 70 scientific abstracts accepted and presented with partner clinics at conferences worldwide.
Christine Prada, CEO, Future Fertility, said: “Fertility treatment is one of the most emotionally and physically demanding experiences a person can go through.
“Every patient deserves objective data, not just a best guess, to support better decisions at critical moments in their care.
“This funding means we can bring that clarity to more patients, in more countries, at a moment when it matters most.”
Find out more about Future Fertility at futurefertility.com
Entrepreneur
Women’s HealthX confirms exceptional speaker line-up to advance fertility and reproductive care
By Women’s HealthX
Women’s HealthX has confirmed an outstanding cohort of fertility and reproductive care leaders for its upcoming event, bringing together the senior clinicians, medical directors, and innovators shaping evidence-based practice across hospitals and healthcare systems globally.
Timed to coincide with Infertility Awareness Week, this announcement underscores the event’s commitment to accelerating the adoption of evidence-based innovations in fertility and reproductive medicine.
Find out more about Women’s HealthX
Headline Speaker
Fireside Chat: The Invisible Disease: What Endometriosis Reveals About the Future of Women’s Health
Padma Lakshmi, Co-Founder, Endometriosis Foundation of America
Confirmed Speakers from World-Leading Institutions and confirmed sessions
Training the Next Generation of Fertility HCPs
Alan Penzias, Director, Fellowship Program in Reproductive Endocrinology & Infertility, Beth Israel Deaconess Medical Center
Shaping the Future of Fertility Care
Lynn Mason, Chief Executive Officer — North America, IVIRMA Global
Ovarian Aging and Reproductive Potential: What Truly Matters
Mark Trolice, Founder & Medical Director, The IVF Center
The Patient Journey Through Fertility Care: Improving Experience & Outcomes
Adam Balen, Chief Medical Officer / Professor of Reproductive Medicine, Leeds Teaching Hospitals NHS Trust
Designing Women’s Health Around The Whole Woman: A Life-Course Model for Sustainable Outcomes
Malissa Wood, Chief Medical Officer, Women as One
Prolong Fertility Preservation by Highlighting Ovarian Insufficiency Through Genetic Variant Data Analysis
Julie Rios, Division Director, Reproductive Endocrinology & Infertility, UPMC
What Attendees Will Take Away
How to improve the fertility patient journey and outcomes
- Ways to detect ovarian aging earlier using genetic insights
- Strategies to deliver care across the full female life course
- Approaches to training the next generation of fertility specialists
Women’s HealthX spans seven dedicated stages covering the full lifecycle of women’s health — from fertility and sexual health to maternity and menopause — providing attendees with actionable insights from frontline leaders across hospitals and healthcare systems.
With Chief Medical Officers and senior clinical leaders in attendance, the programme moves beyond discussion into delivery, giving attendees direct access to the latest clinical evidence, emerging digital tools, and real-world outcomes data to support integrated, high-quality care.
REGISTER NOW FOR A CHANCE TO WIN A FREE THERAPEUTIC MASSAGE
Complimentary passes are available for qualified healthcare professionals.
Attendees who register by 15 May will gain full access to all seven stages and a chance to receive a complimentary therapeutic massage at Encore Boston.
Register your complimentary place
For speaking opportunities, partnership enquiries, or further information, please contact the team directly at info@alpahevents.com
Cervical cancer elimination in the EU is becoming achievable as HPV vaccination coverage rises, a new report says.
As Europe marks European Immunisation Week 2026, the European Centre for Disease Prevention and Control said progress in human papillomavirus vaccination is continuing across the EU and European Economic Area.
All EU and European Economic Area countries now recommend HPV vaccination for adolescent girls and boys as part of their immunisation programmes, marking a major step forward in Europe’s cancer prevention efforts.
Bruno Ciancio, head of unit, directly transmitted diseases and vaccine preventable diseases at the European Centre for Disease Prevention and Control, said: “The elimination of cervical cancer in the EU/EEA is becoming an achievable goal, thanks to the HPV vaccination programmes.
“The progress we are seeing across Europe demonstrates what can be accomplished when countries invest consistently in effective immunisation strategies.
“We are closely monitoring this progress and actively supporting countries to accelerate uptake and move faster towards cervical cancer elimination.”
According to the report, three EU and European Economic Area countries, Iceland, Portugal and Norway, have reached the 2024 EU Council Recommendation target of 90 per cent HPV vaccination coverage among girls by the age of 15.
Fifteen years after HPV vaccination programmes were introduced in Europe, a growing body of evidence confirms the vaccine is highly effective in preventing cervical cancer.
Large-scale studies from Sweden, the Netherlands and Denmark, as well as other parts of the world, have shown significant reductions in HPV infections and precancerous lesions, which are abnormal cell changes that can develop into cancer if left untreated, alongside falling cervical cancer rates among vaccinated women.
Since 2020, European countries have reported a decreased incidence of cervical cancer among vaccinated women.
Studies from Sweden, Denmark and the UK show that early administration of the vaccine increases its full protective potential.
A Swedish study suggested that vaccinating girls before their 17th birthday reduced the incidence of cervical cancer by 88 per cent.
An additional six-year follow-up found a sustained reduction in cervical cancer risk and a population-level decline in invasive cervical cancer incidence after HPV vaccination.
The report showed that vaccination programmes and health system design are critical factors in reaching high levels of HPV vaccination coverage.
Evidence from across Europe showed that school-based vaccination programmes are particularly effective and tend to reach higher levels of coverage among both girls and boys.
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