News
Drug for metastatic cervical cancer approved by the European Commission
The treatment was able to reduce the risk of death by 31 per cent compared to chemotherapy during study

A drug that demonstrated significant survival benefit in patients with recurrent or metastatic cervical cancer has been approved by the European Commission.
Regeneron Pharmaceuticals has announced that the European Commission (EC) approved Libtayo (cemiplimab) as monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.
The EC approval in advanced cervical cancer is based on data from the global phase 3 trial, which was conducted with the GOG Foundation, the European Network for Gynaecological Oncological Trial groups (ENGOT) and NRG Oncology-Japan.
The trial evaluated Libtayo in comparison to an investigator’s choice of chemotherapy and enrolled 608 patients across 14 countries, irrespective of PD-L1 expression status or histology.
In March 2021, the trial was stopped early based on the highly significant effect of Libtayo on overall survival (OS) among squamous cell carcinoma (SCC) patients following a unanimous recommendation by the Independent Data Monitoring Committee.
“Despite recent advancements in the prevention and treatment of cervical cancer, there remain limited options for people with recurrent or metastatic cases,” said Israel Lowy, senior vice president at Regeneron.
“Libtayo was the first PD-1 inhibitor to demonstrate significant improvements in survival compared to chemotherapy in a Phase 3 trial.
“With this fourth approval from the European Commission, Libtayo can now be extended to appropriate patients in the European Union with advanced cervical cancer, irrespective of their PD-L1 status or histology.”
Professor Ignace Vergote, investigator and gynaecologist oncologist at University Hospitals Leuven in Belgium, and vice-chair of the Trial Steering Committee, said: “Consistent with our mission to bring the best treatments to patients across Europe living with gynaecological cancers, we are proud to have been a part of this landmark trial for Libtayo.
“Libtayo is an important advancement for patients with recurrent or metastatic cervical cancer whose disease has progressed following platinum-based chemotherapy and could offer a new standard of care in this setting.
“We are grateful to those who participated in the trial and to our partners at Regeneron, ENGOT, the GOG Foundation and NRG Oncology-Japan without whom this approval would not have been possible.”
Cervical cancer is the fourth leading cause of cancer death in women worldwide and is most frequently diagnosed between the ages of 35 and 44.
Approximately 600,000 new cases of cervical cancer and 350,000 deaths from cervical cancer occur worldwide each year.
Almost all cases are caused by human papillomavirus (HPV) infection, with approximately 80 per cent classified as squamous cell carcinoma – arising from cells lining the external portion of the cervix – and the remainder largely adenocarcinomas – arising from glandular cells lining the internal portion of the cervix.
Cervical cancer is often curable when detected early and effectively managed, but treatment options are more limited in advanced stages.
In addition, Libtayo has also been approved in the EU for the treatment of three other types of cancer, including certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC) and advanced non-small cell lung cancer (NSCLC).
Wellness
Congress urged to invest over $20bn to close women’s health gap

Congress is being urged to invest US$20bn over 10 years to close the women’s health gap.
The American College of Obstetricians and Gynecologists, the Society for Women’s Health Research and the Women First Research Coalition have unveiled the National Strategy to Close the Women’s Health Gap.
The framework calls for a coordinated national effort to improve women’s health research, care and outcomes.
It says women make up more than half of the US population, but their health needs across conditions and life stages have been understudied and underserved for decades.
Kathryn Schubert, president and chief executive of the Society for Women’s Health Research, said: “The women’s health gap has persisted for far too long.
“This strategy offers Congress a road map to improve health outcomes, drive innovation, and build a healthier future for women, families, and communities.”
The strategy notes that Congress required women to be included in National Institutes of Health-funded clinical research through the NIH Revitalization Act in 1993.
However, it says major gaps remain in women’s health research, clinical care and how evidence is put into practice.
The plan proposes US$7bn for research and innovation, including expanded federal investment in women’s health research across the NIH, VA, DoD and the Advanced Research Projects Agency for Health.
It would also establish a Women’s Health Research Interdisciplinary Fund at the NIH and create a national network of Women’s Health Centers of Excellence.
The centres would aim to accelerate the translation of research into clinical care and serve as training sites for researchers and clinicians.
A further US$1bn would be used for regulatory coordination and modernisation, including cross-agency collaboration and work to address sex differences in drug and treatment approvals.
Sex differences are biological differences between females and males that can affect disease risk, symptoms, treatment response and side-effects.
The funding would also support updated NIH tracking systems for women’s health research investment and publication standards on how sex as a biological variable is considered in research.
The strategy calls for US$4bn for data and evidence infrastructure, including a public-private partnership focused on women’s midlife health data.
It would also convene a public workshop to review existing women’s health research datasets and develop common data elements to fill gaps and make datasets more widely available.
Another US$7bn would go towards strengthening the clinical and research workforce.
This would include career pathways, loan repayment programmes, a women’s health clinical workforce loan repayment programme modelled on the National Health Service Corps and interdisciplinary training.
The workforce measures would include particular emphasis on rural and underserved areas.
The final US$1bn would support public awareness and education campaigns to improve health literacy, preventive care and participation in women’s health research.
Health literacy means a person’s ability to find, understand and use health information to make decisions about care.
The campaigns would use digital and traditional media developed in consultation with patient advocacy organisations and relevant medical societies.
Sandra E Brooks, chief executive of the American College of Obstetricians and Gynecologists, said: “Closing the women’s health gap requires not only funding research, but also investment in the people who conduct that research and those who translate research findings and discoveries into better patient care.
“Strengthening the women’s health research and clinical workforce is critical to accelerating the innovation needed to improve health outcomes for women.”
The strategy says women have higher annual out-of-pocket healthcare costs than men and live 25 per cent of their lives in poorer health.
Supporters say this strengthens the economic and public health case for long-term congressional investment.
The framework has been endorsed by organisations across women’s health, ageing, heart disease, autoimmune disease, cancer, reproductive medicine and neurological conditions, including the Women’s Alzheimer’s Movement at Cleveland Clinic, the National MS Society and UsAgainstAlzheimer’s.
Hormonal health
Stardust period tracker shares health data, study reveals
Stardust shared sensitive period tracking data with third-party analytics firms, according to new privacy research from Mozilla.
The findings expose a privacy divide in femtech, where users often trust apps with highly sensitive reproductive health information.
The research was carried out by Mozilla’s Privacy Not Included team, which tested several period tracking apps.
It found that Stardust, a period tracker used by millions, shared users’ reproductive health data with analytics companies, a practice the research said contrasted with its privacy-first marketing.
Analytics companies collect and examine information about how people use digital products, often to help businesses understand user behaviour or improve marketing.
The findings raise questions about whether privacy promises made by health apps match what happens to users’ data.
According to research reported by TechCrunch, one other period tracking app tested by Mozilla received what researchers called a “squeaky clean” rating, suggesting similar services can operate without sharing sensitive health data in the same way.
Period tracking apps have come under greater scrutiny in the US since the 2022 overturning of Roe v Wade, which removed federal constitutional protection for abortion.
Some users and privacy advocates have warned that menstrual and reproductive health data could potentially be sought in legal cases.
The research also points to a broader regulatory problem for consumer health apps.
In the US, many health apps are not covered by HIPAA, the health privacy law that applies to medical providers and some healthcare organisations.
That means some consumer apps may be able to collect, share or monetise sensitive health data under rules that differ from traditional healthcare privacy protections.
The femtech market, estimated in the report at US$50bn, has grown quickly, but privacy regulation has not always kept pace with app development.
Stardust had not publicly responded to Mozilla’s findings at the time of the original report, and its privacy policy remained live on its website.
The issue is particularly sensitive for period tracking because the data can reveal patterns around fertility, pregnancy, contraception and reproductive health.
Mozilla’s wider Privacy Not Included initiative has examined consumer technology products for privacy and security concerns since launching in 2017, including connected devices, children’s toys and health apps.
The findings come as US lawmakers continue to debate stronger federal privacy rules for sensitive health information collected by consumer apps.
The American Data Privacy and Protection Act, which has been stalled in Congress since 2023, includes provisions addressing sensitive health information collected by consumer apps.
Experts have also warned that anonymised health data can sometimes be re-identified when combined with other information, such as location data.
Re-identification means linking supposedly anonymous data back to a specific person.
A 2019 study found that menstrual cycle data combined with location information could identify individual users with high accuracy.
State-level privacy laws in places such as California, Virginia and Colorado have also given consumers new rights around personal data, although enforcement can vary.
Privacy advocates say the research underlines the need for clearer data practices, stronger safeguards and greater transparency in femtech.
For users, the findings are a reminder that health apps do not automatically protect health information in the same way as healthcare providers.
The report suggests period tracker companies that put privacy first may be better placed to build trust in a market where long-term use depends on confidence.
Mozilla’s investigation suggests privacy promises in femtech do not always match practice, and that period trackers can function without sharing sensitive user data in the same way.
News
Juno Bio secures US$3.8m for precision diagnostics

Juno Bio has secured US$3.8m to expand its diagnostics platform for vaginal health and reproductive care.
The funding round was led by Ada Ventures, with participation from Artesian, Entrepreneur First and Illumina Accelerator.
The women’s health startup said the seed funding will support the launch of its first CLIA-certified sequencing laboratory in Oakland, California, and a new clinical vaginal microbiome and STI test for healthcare providers.
CLIA certification refers to US laboratory standards for testing human samples used in diagnosis, prevention or treatment decisions.
Dr Leighton Turner, co-founder and chief scientific officer of Juno Bio, said: “The vaginal microbiome is still one of the least understood systems in the body at a clinical scale.
“With our lab, we’re starting to build a measurement standard that clinicians can actually use.
“We believe the level of detail from this kind of testing can meaningfully improve how vaginal healthcare is provided.”
The company is developing precision diagnostics for vaginal health, where patients can experience recurring symptoms, inconsistent diagnoses and treatments based on trial and error.
Juno Bio said bringing testing in-house gives it greater control over the process, from sample handling to results, while allowing it to refine its technology and build what it says is one of the largest datasets focused on the vaginal microbiome.
The vaginal microbiome is the community of bacteria and fungi that naturally live in the vagina. Changes in this balance can be linked to infections, symptoms and wider reproductive health issues.
Juno Bio’s newly launched clinical test examines the wider vaginal microbiome and screens for four common sexually transmitted infections, or STIs.
Rather than looking for a single cause, the test is intended to give clinicians a broader picture of what may be contributing to symptoms.
Juno Bio says this matters because multiple infections can occur at the same time and microbiome changes may be linked to fertility, menopause or recurrent infections.
Dr Anna Powell of Johns Hopkins said: “Vaginal microbiome testing has the potential to significantly reshape how we understand and manage vaginal health, particularly for patients with recurrent or unexplained symptoms.
“While the field is still evolving, advances in sequencing and data interpretation are moving us closer to a future where more personalised, microbiome-informed care can complement existing diagnostic approaches.”
Check Warner, co-founding partner at Ada Ventures, added: “Juno Bio is setting a new standard for how vaginal health is understood and managed.
“What they’ve built at this stage, with this level of capital efficiency, is exceptional.
“We’re proud to support the team as they scale their clinical infrastructure and continue leading innovation in this critically underserved category.”
Diagnosis2 weeks agoTwo “gamechanger” tests set to speed up endometriosis diagnosis on the NHS
Insight2 weeks agoWomen with PMOS should have annual NHS checks, new guidance says
News4 days agoNew menopause drug approved for use by NHS in Scotland
Cancer1 week agoThousands of women could avoid painful cancer exam with new AI blood test
Entrepreneur1 week agoApplications open for the third W Accelerate with Merck KGaA and M Ventures
Fertility2 weeks agoOlder women face lower chance of fertility treatment working, even with donor eggs, study finds
News1 week agoWe built Ema like a nurse: Here’s why that matters
News2 weeks agoExperts call for regulation of toxic period product chemicals











1 Comment