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Round up: Trial to evaluate ovarian cancer drug candidate and more

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Femtech World explores the latest research developments in the world of women’s health.

Fertility treatments linked to higher mutations than natural conception

Mice that were conceived with IVF in the lab have slightly increased rates of DNA errors, or mutations, compared to pups conceived naturally, a new study suggests.

While the results do not directly apply to humans, they highlight the importance of understanding how fertility treatments affect an offspring’s DNA.

The researchers compared genome sequences of lab mice conceived naturally and mice conceived through assisted reproductive technologies, including hormone treatments, IVF, and embryo transfer.

They discovered pups born through these fertility treatments had about 30 per cent more new single-nucleotide variants, or tiny changes in DNA sequences.

Nucleotides are DNA’s building blocks or “letters.” Arranged in specific sequences, these letters compose the instructions cells use to grow and function.

Single-nucleotide variants are simply genetic differences (or mutations) involving a change in just one DNA letter. They can occur when cells replicate their DNA.

The mutations observed in the study are unlikely to be harmful.

Scientists estimate that fewer than 2 per cent of new mutations arising in a genome are deleterious or have an impact on an individual’s phenotype or disease susceptibility, the researchers said.

The mutations appeared spread across the genome, rather than clustered in particular genes.

The timing of when these new mutations appeared in early embryos also looked similar between fertility-treated and natural groups, implying that fertility treatment increases the overall chance of new DNA changes but does not impact when they occur during development.

Even with a 30 per cent increase in new mutations, the absolute number of harmful new mutations per mouse remains low.

For about every 50 mice conceived with IVF, scientists expect roughly one additional harmful DNA change compared to natural conception.

That is one problematic change out of many possible ones, since the mouse genome is about 2.7 billion DNA letters long.

A similar effect is expected if the male parent’s age increased by about 30 weeks, since paternal age is a major driver of mutation rates in mammals.

The biological mechanisms underlying these genetic changes are not clear.

Further research is needed to study whether the new mutations come from a specific step in the IVF process or from the combined effects of several steps.

One possible factor is the use of hormone treatments that stimulate the ovaries, since these hormones push eggs to restart meiosis, a stage of cell division known to be prone to mistakes.

Other aspects of the fertility treatment protocol could also play a role, such as physical handling of embryos or the chemical conditions of the lab culture environment.

The study does not show whether the same effect happens in humans. Fertility procedures vary between mice and humans, and both have different reproductive biology.

For example, mice do not menstruate. Also, people seeking IVF will likely encounter environmental factors that may already have affected their genetics.

First patient enrolled in study evaluating sofetabart mipitecan in recurrent ovarian cancer

The GOG Foundation has announced the enrollment of the first patient in GOG-3133, a Phase 3 clinical trial evaluating sofetabart mipitecan in recurrent ovarian cancer.

Sofetabart mipitecan is a novel folate receptor alpha-targeting antibody-drug conjugate featuring an exatecan payload.

In early-phase studies, sofetabart mipitecan demonstrated robust and durable clinical activity with an ORR of 50 per cent among 104 heavily pre-treated patients with platinum-resistant ovarian cancer (PROC), across all range of FRα expression levels, and in patients previously treated with mirvetuximab soravtansine with negligible rates of interstitial lung disease and peripheral neuropathy and no ocular toxicity or alopecia.

This clinical trial, sponsored by Eli Lilly and Company, has two parts; it tests a potential new medicine called sofetabart mipitecan for people with certain types of ovarian, peritoneal, and fallopian tube cancers.

Part A looks at participants whose cancer no longer responds to platinum-based chemotherapy (platinum resistant).

Part B looks at participants whose cancer has a higher chance of responding to platinum-based chemotherapy (platinum sensitive).

The FRAmework-01 study aims to address the need for more effective therapies in both platinum-resistant and platinum-sensitive ovarian cancer.

Young people in Wales to receive new information about women’s health

The Women’s Health Network has worked with school nurses and learners across Wales to develop resources for women’s health.

Girls and boys contributed to ensure they reflect the information young people need.

The resources, which were launched this week by the Minister for Mental Health and Wellbeing, Sarah Murphy, cover 4 key areas including menstrual health, endometriosis, pelvic health, and menopause.

Secondary schools will be able to adapt the resources to include their own branding.

The materials work across multiple platforms, including email, leaflets, posters, social media and QR codes.

They are designed to reduce stigma around periods, help young people recognise when to seek medical help, and raise awareness of conditions like endometriosis.

They also provide information on pelvic health and menopause to support understanding of health issues throughout their lives.

Members of the Cardiff and Vale University Health Board youth panel who helped create the materials were at the launch event at the Children’s Hospital in Cardiff.

Sarah Murphy, Minister for Mental Health and Wellbeing, said: “These new resources will help to support the health and wellbeing of young people across Wales.

“By working directly with young people to develop these materials, we’ve ensured they address the real questions and concerns they have.

“I’m grateful to all the young people who have contributed their insights and experiences to make these materials relevant and accessible.

“This is part of our commitment to address the gender health gap and improve health outcomes for women and girls across the country.”

Nestlé joins UN-led coalition supporting women’s health

Nestlé has announced it has joined the Coalition for Reproductive Justice in Business, led by the United Nations Population Fund (UNFPA).

The coalition aims to drive private-sector investment into  advancing comprehensive health policies and measurable standards for women’s health across workplaces, supply chains, and broader business ecosystems.

“We are proud to join this initiative and collaborate with UNFPA and other coalition members to redefine how businesses address women’s health,” said Serena Aboutboul, global head of nutrition division at Nestlé.

“From maternal health to menopause, our commitment is unwavering.

“We provide innovative and tailored nutrition solutions, ensure respectful workplace conditions, and increase support to women. When women thrive, families, communities, and economies flourish.”

The coalition’s work supports the UN Sustainable Development Goals on Good Health and Wellbeing and Gender Equality.

By becoming a coalition member, Nestlé will help strengthen broader corporate action in line with the UNFPA’s scorecard of metrics and indicators for women’s health and wellbeing in the workplace.

“We welcome companies taking concrete steps to strengthen women’s health and rights in the workplace,” says Mariarosa Cutillo, UNFPA private sector and civil society branch chief.

“By joining the Coalition, Nestlé signals its commitment to advancing measurable standards and supporting a future where women’s health is recognised as central to business success and societal well-being.”

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Higher nighttime temps linked to increased risk of autism diagnosis in children – study

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Nighttime temperatures during pregnancy may be linked to a higher chance of an autism diagnosis in children, a recent study suggests.

The research tracked nearly 295,000 mother-child pairs in Southern California from 2001 to 2014 and linked warmer overnight temperatures with higher risk in early and late pregnancy.

Children of mothers exposed to higher than typical nighttime temperatures during weeks one to 10 of pregnancy had a 15 per cent higher risk of an autism diagnosis.

Exposure during weeks 30 to 37 was linked to a 13 per cent higher risk.

 Lead author David Luglio, a post-doctoral fellow at Tulane University, said: “A key takeaway is that we identified specific windows when a mother and her developing child can be most affected by exposures to higher nighttime temperatures.

“This is critical and hopefully can help mothers prepare accordingly.”

The study is described as the first to examine how temperature may affect fetal neurodevelopment, the process by which a baby’s brain and nervous system form during pregnancy.

Extreme temperatures linked to increased risk were classified as above the 90th percentile, meaning 3.6°F hotter than average, and the 99th percentile, 5.6°F above average.

The association held even after researchers accounted for factors such as neighbourhood conditions, vegetation and fine-particle air pollution.

The study could not account for other factors such as access to air conditioning. Researchers did not find the same association with daytime temperatures, potentially because people spend more time away from home during the day.

“Heat waves are becoming more frequent, and people may only think of the dangers of daytime heat exposure,” said Mostafijur Rahman, assistant professor of environmental health sciences at Tulane University.

“These results indicate a strong association between high nighttime temperatures during pregnancy and autism risk in children and show that we need to think about exposure to heat around the clock.”

The study did not examine how higher temperatures at night might affect prenatal development, though Luglio said it is possible that warmer nights disrupt sleep for pregnant mothers.

Previous research has suggested insufficient sleep during pregnancy may be linked to a higher risk of neurocognitive delays in children.

“Extreme heat exposure during pregnancy has been linked to a range of adverse health outcomes, including prenatal neurodevelopment delays and complications with an embryo’s development of a central nervous system,” Luglio said.

“The goal of our study was to specifically explore the link between prenatal heat exposure and autism diagnoses for the first time.”

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WHO hosts parliamentary dialogue on women’s health

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The World Health Organization (WHO) welcomed a delegation of parliamentarians to its Geneva headquarters for a high-level dialogue on women’s health and sexual and reproductive health and rights.

The meeting on 20 January 2026 focused on women’s health, sexual and reproductive health and rights, noncommunicable diseases (long-term conditions such as cancer and diabetes) and global health cooperation.

The exchange was convened by the Konrad-Adenauer-Stiftung and the UNITE Parliamentarians Network for Global Health, bringing together parliamentarians from Albania, Germany, Georgia, Mexico, Slovakia, South Africa, Sri Lanka, Sweden and Zimbabwe.

A central theme was the need to move beyond fragmented approaches to women’s health.

Dr Alia El-Yassir, WHO director for gender, equity and diversity, highlighted that outcomes are shaped by gender inequalities, social norms and structural barriers across the life course, requiring coordinated action across health systems.

Thirty years after the Beijing Declaration and Platform for Action, a landmark framework adopted in 1995 to advance gender equality and women’s rights, Dr Anna Coates, WHO gender equality technical lead, noted that progress on women’s health remains uneven.

She called for health systems that are more gender-responsive and able to address women’s health holistically across the life course.

Parliamentarians stressed that health is inseparable from wider social and economic policies, and called for stronger links between evidence, legislation and measurable impact at country level.

The meeting also focused on sexual and reproductive health and rights, where parliamentarians expressed interest in engaging on issues that directly affect their constituents.

Dr Pascale Allotey, director of WHO’s Department of Sexual, Reproductive, Maternal, Child, Adolescent Health and Ageing, outlined WHO’s life-course approach to sexual and reproductive health and rights.

She highlighted how needs evolve from birth to older age and how these are shaped by social determinants, humanitarian crises and demographic trends.

Dr Allotey underscored the role of parliamentarians in advancing sexual and reproductive health and rights and the importance of continued engagement with WHO to support evidence-based policy-making.

The agenda highlighted cancer as a growing priority for women’s health and for health system sustainability. Dr Prebo Barango, lead for the Cervical Cancer Elimination Initiative, Dr Meghan Doherty, consultant for palliative care, and Santiago Milan, lead for the WHO Global Platform for Access to Childhood Cancer Medicine, presented WHO’s integrated approach to cancer control.

Palliative care is treatment and support that aims to improve quality of life for people with serious illness by managing pain and other symptoms.

The discussion underlined the need for sustained political commitment and domestic investment to address noncommunicable diseases.

Parliamentarians shared national experiences showing the social and economic impacts of cancer on families and caregivers, reinforcing the importance of improving health literacy, reducing stigma and delivering people-centred care.

The meeting also addressed the state of global multilateralism.

Dr Jeremy Farrar, assistant director-general for health promotion, disease prevention and care, outlined how WHO has restructured to enhance efficiency, impact and capacity to support countries.

He reaffirmed WHO’s commitment to more systematic engagement with parliaments, recognising their role in shaping health policy, legislation and budgets.

The exchange concluded with a call for continued collaboration, including through partnerships with the Konrad-Adenauer-Stiftung and the UNITE Parliamentarians Network for Global Health, ahead of the UNITE Global Summit 2026 on 6–7 March in Manila, the Philippines.

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FDA approves Agilent test for ovarian cancer

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Agilent has FDA approval for a test to identify ovarian cancer patients who may be eligible for immunotherapy.

Agilent’s PD-L1 IHC 22C3 pharmDx is the only FDA-approved companion diagnostic to help identify patients with epithelial ovarian, fallopian tube or primary peritoneal carcinoma whose tumours express PD-L1 and who may be eligible for treatment with KEYTRUDA, Merck’s anti-PD-1 therapy.

A companion diagnostic is a test used alongside a specific treatment to show whether a patient is suitable for that therapy. PD-L1 is a protein on some cancer cells that helps tumours evade the immune system.

These cancers affect the reproductive system and the lining of the abdominal cavity.

The test enables pathologists to assess PD-L1 expression at diagnosis to support treatment decisions in a disease where options remain limited for many.

This is the seventh FDA-approved companion diagnostic indication for PD-L1 IHC 22C3 pharmDx for use with KEYTRUDA.

Nina Green, vice president and general manager of Agilent’s clinical diagnostics division, said: “Delivering effective precision oncology requires close collaboration between diagnostics and therapeutics, and this FDA approval reflects Agilent’s long-standing industry partnership in companion diagnostics.

“We are proud to enable pathologists to identify patients with EOC who may benefit from immunotherapy.

“As the first immuno-oncology approval for this disease, this milestone underscores our commitment to advancing precision medicine and expanding access to innovative cancer treatments worldwide.”

PD-L1 expression with this test was evaluated in the KEYNOTE-B96 clinical trial supporting its use to identify patients who may benefit from KEYTRUDA.

In the US, ovarian cancer caused approximately 12,730 deaths in 2025 and the five-year survival rate was 51.6 per cent between 2015 and 2021.

In addition to these cancer types, the test is indicated in the US to help identify patients with non-small cell lung cancer, oesophageal squamous cell carcinoma, cervical cancer, head and neck squamous cell carcinoma, triple-negative breast cancer and gastric or gastro-oesophageal junction adenocarcinoma who may benefit from treatment with KEYTRUDA.

The test was developed by Agilent with Merck as a companion diagnostic for KEYTRUDA.

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