News
FDA approves new menopause drug to treat hot flashes and night sweats

The FDA has approved elinzanetant, a new non-hormonal treatment for menopause that reduces hot flushes and night sweats.
Clinical trials in the US, Europe and Israel found the drug significantly reduced both the frequency and severity of hot flushes while improving women’s sleep and quality of life.
The approval follows successful results from the double-blind Oasis trials, led by UVA Health and other international research partners.
The studies enrolled postmenopausal women aged 40 to 65 with moderate to severe hot flushes, randomly assigning them to receive either 120mg of elinzanetant daily for 26 weeks or a placebo for 12 weeks followed by 14 weeks of the drug.
Women who received the treatment reported rapid improvements, with statistically significant reductions in the frequency and intensity of hot flushes within the first week.
By week 12, sleep quality and overall quality of life had also improved across both trials.
JoAnn V. Pinkerton is director of midlife health at UVA Health and US lead for the Oasis II trial.
Pinkerton said: “More than a third of women experience disruptive menopausal symptoms that can persist for more than a decade, significantly impacting work, home and quality of life.
“Many symptomatic menopausal women continue to suffer without treatment and support.
“With the FDA approval of elinzanetant, women will have access to a new, safe and effective therapy for relief of hot flushes and night sweats.
“Due to its dual receptor antagonism, the studies also showed improvements in sleep and mood.”
Hot flushes are caused by a drop in oestrogen levels during menopause, which affects how the brain regulates body temperature.
Hormone therapy remains the most effective treatment, but it can cause side effects such as breast tenderness, bloating, headaches or spotting.
In rare cases, long-term hormone use, particularly oral therapy, can raise the risk of blood clots, strokes or certain cancers such as uterine cancer if oestrogen is used without a uterine antagonist — a drug that blocks its effects on the womb.
Some women cannot take hormone therapy due to contraindications such as a history of blood clots or oestrogen-sensitive cancers.
Elinzanetant works through dual receptor antagonism, blocking two receptors involved in temperature regulation and other menopausal symptoms.
The most common side effects seen in the trials were mild headache and fatigue. No serious side effects were reported.
Pinkerton said: “I am excited that women who can’t or choose not to take hormone therapy will have access to elinzanetant, which is an effective and tested, FDA-approved therapy for bothersome symptoms.
“It’s critical that we listen to our patients to understand exactly what they are experiencing and then help them get the support they need, tailored to their individual needs.”
Opinion
Thriving through the ups and downs: A guide to women’s mental health

By Naomi Magnus, psychotherapist and founder at North London Therapy
Women’s health is closely linked to our biology, hormones, and the way our brains are wired, all of which shape our life experiences.
From the teen years right through to adulthood, hormonal ups and downs can affect mood, thinking, and emotional resilience in ways that are uniquely female.
Oestrogen and progesterone, for instance, don’t just influence fertility – they also play a key role in regulating neurotransmitters like serotonin and dopamine, which affect mood and anxiety.
In your twenties, when careers, relationships, and life choices are all coming together, it’s perfectly normal to feel anxious or low at times.
Anxiety disorders can often be connected to women’s hormonal and neurological differences. Recognising this can be really reassuring – anxiety can simply be a reflection of a complex, finely tuned system.
A woman’s menstrual cycle can have a big impact on energy, focus, and mood throughout their life, yet many women aren’t taught to track or anticipate these changes.
Later on, life events like pregnancy, postpartum shifts, and perimenopause bring even bigger hormonal swings, which can trigger mood changes, brain fog, or longer-term mental health challenges.
Schools have a crucial role to play in helping young women understand their bodies and mental health.
While the current UK national curriculum covers basic reproductive biology and puberty, it often misses the full picture of hormonal cycles, mental health, and the connection between the two.
Comprehensive education should include tracking menstrual cycles, recognising mood and energy patterns, understanding stress and anxiety triggers, and helping young girls to develop healthy coping strategies.
Teaching these skills early on equips girls with self-awareness, confidence, and the tools to manage their physical and emotional wellbeing throughout life.
Menopause is another life stage that brings significant hormonal changes, which can affect mental health.
As oestrogen and progesterone decline, many women notice mood swings, anxiety, low energy, and brain fog.

Naomi Magnus
Lifestyle adjustments can help – regular exercise, a balanced diet rich in omega-3s and whole foods, good sleep hygiene, and mindfulness or meditation practices can all support mood and cognitive function.
Therapy, such as cognitive behavioural therapy (CBT) or counselling, is effective for managing anxiety or low mood.
For some, hormone replacement therapy (HRT) may be recommended by a GP or specialist to stabilise hormones and alleviate both physical and psychological symptoms.
Women – at any age – can help themselves to feel better when hormone changes strike.
I am an advocate for mindfulness, good sleep, gentle exercise, socialising, and tracking your cycle alongside your mood.
Technology is stepping up – there are some amazing apps that make it easier to understand how your mental health and hormones interact.
It’s also worth acknowledging that times are tough globally – economic uncertainty, climate anxiety, and social pressures can all take their toll on our mental health.
While we can’t control everything around us, getting to know our own bodies and how we respond to stress can make a real difference.
By tuning into our cycles, moods, and energy levels, we can better anticipate challenging days and create a sense of calm amidst the chaos.
Understanding that women’s brains and mental health respond differently across life stages is really important.
Women should approach mental health proactively – because thriving isn’t just about surviving, it’s about knowing your mind and body inside out.
News
Ending the guesswork in cancer care: A CEO’s vision for predictive precision oncology

By Wolfgang Hackl M.D., Founder & CEO, OncoGenomX Inc., Switzerland
During my career as an oncologist and cancer drug developer, one question haunted me more than any other: Why do some patients respond to therapy — while others, with the same diagnosis, do not?
We have innovative treatments, biomarkers, advanced lab tests, and guidelines. But far too often, despite all that science, our treatment decisions come down to educated guesswork.
As medicine evolves, so do our data — but not always our ability to act on it with precision.
That enduring gap between what we know and what we can predict inspired me to found OncoGenomX, and to build PredictionStar™, a platform designed to redefine what precision oncology truly means.
From Biomarkers to Behavior: The Missing Link
Today, most molecular cancer tests focus on eligibility: they tell us whether a tumour expresses a particular target or carries a known mutation. This is useful, but it’s only half the story.

Eligibility does not equal efficacy.
Knowing that a patient’s tumour expresses the estrogen receptor (ER), or harbours a PIK3CA mutation, doesn’t mean it will respond to hormone therapy or PI3K inhibition. It simply means those drugs might work. And in oncology, “might” is not enough.
PredictionStar™ was built to close this precision gap — by answering not just which drugs can be used, but which will actually work.
We call this Precision Drug–Tumor Matching: the ability to segregate effective from ineffective treatments by connecting genomic and phenotypic insights into a coherent tumour profile predictive of therapeutic response.
Introducing PredictionStar™: Coherent Biomarker Intelligence
PredictionStar™ is a multidimensional tumour profiling and decision-support system powered by what we term Generative Clinical Intelligence™ — the synthesis of high-quality sequencing data and AI-driven interpretation into clear, actionable clinical guidance.
 Traditional assays analyse biomarkers in isolation, treating each gene mutation or expression pattern as a separate clue.
Traditional assays analyse biomarkers in isolation, treating each gene mutation or expression pattern as a separate clue.
PredictionStar™ instead identifies logically connected biomarker constellations — genomic enablers that reveal which response mechanisms are active, and phenotypic differentiators how likely the tumour will respond.
This networked approach replaces fragmented snapshots with an integrated, functional map of tumour behaviour.
It provides oncologists with something they rarely get from today’s tests: confidence. In clinical modelling, PredictionStar™ has the potential to reduce overtreatment fivefold and lower the cost of achieving one year of tumour growth control by 35 per cent.
But the numbers tell only part of the story. Behind them are patients spared from unnecessary toxicity — and doctors empowered to treat with precision instead of probability.
Built on the Technology of Giants
PredictionStar™ was designed for seamless integration into modern real-world workflows, harmonized and cross-validated to ensure reliability, and reproducibility.

The platform’s pre-sequencing tumor workup is fully standardised, minimizing inter-laboratory variability that can otherwise reach 70 per cent.
From tumour processing to data interpretation, PredictionStar™ enforces the same rigorous quality in every step, producing consistent and concordant results across labs.
As far as cloud architecture optimized for medical data privacy and global scalability we are privileged to work with world class-players of the health IOT industry
 (F. Gaede, Oct 2025, Nordcloud).
A Femtech Focus: Personalising Breast Cancer Therapy
While PredictionStar™ has broad oncology applications, our first focus is hormone receptor-positive breast cancer, the most prevalent form among women.
It is here that the limits of current diagnostics are most evident — and the need for predictive and prescriptive clarity is greatest.
 Even within hormone-dependent breast cancer, the most favorable form of the disease, patient outcomes vary widely. Some women respond beautifully to endocrine therapy for years, while others progress rapidly.
Even within hormone-dependent breast cancer, the most favorable form of the disease, patient outcomes vary widely. Some women respond beautifully to endocrine therapy for years, while others progress rapidly.
What makes the difference? The answers are buried in the tumour’s individual response profiles — but until now, we lacked the tools to decode them. PredictionStar™ offers that decoding ability.
Our non-interventional validation study, conducted in collaboration with clinical researchers from the Veterans Affairs Medical Centers in Cincinnati, Los Angeles, and Miami, involves data from over 4,300 patients with hormone receptor-positive disease.
By correlating predicted responses with actual treatment outcomes, we aim to establish a new clinical standard for predictive accuracy.
Our roadmap includes RUO and LDT certification in 2026, FDA-IDE clearance in Q2 2027, first RUO test sales as early as Q1 2027, and clinical study use from Q3 2027 onwards.
Redefining Precision Oncology
To understand why this matters, we need to reframe what “precision” means.
Most tests today are prognostic or eligibility-based. They classify risk or confirm target presence. PredictionStar™ adds a third, transformative dimension: functional prediction. It asks, “Which therapies will this specific tumour respond to — and how strongly?”
This evolution turns diagnostics into a true decision-support tool, enabling oncologists to design treatment compositions optimized for efficacy, rather than constrained by averages.
The distinction may seem subtle, but its impact for individuals living with breast cancer is enormous: Prognostic and eligibility tests describe. PredictionStar™ guides.
Innovation Through Unity
Our strength lies in collaboration.
I’ve often said that OncoGenomX stands “on the technology of giants, powered by the ambition to transform.” That is more than a slogan — it’s our reality. We built PredictionStar™ not as an isolated product, but as a platform for partnership.
Its architecture invites integration — with hospital systems, sequencing providers, AI developers, and pharmaceutical R&D pipelines.
In the coming years, we envision PredictionStar™ evolving into a broader family of tools: PredictionStar DX™ for predictive diagnostics, PredictionStar GCI™ for data integration and generation of actionable clinical intelligence, and PredictionStar IOT™ for real-time connectivity. Each module serves the same purpose: to transform complexity into clarity.
From Data to Decisions: A Personal Reflection
At its heart, PredictionStar™ was born from empathy.
As a clinician, I saw too many patients fall through the cracks — not because we lacked treatments, but because we lacked foresight.
Data without interpretation is noise. Our mission is to turn that noise into understanding.
When I speak with oncologists today, I sense both excitement and relief: “We will no longer be limited to maybes.” “We can begin to quantify response likelihood, combine therapies more rationally, and give patients something we cannot give today: certainty”.
Technology can be transformative, but only when anchored in purpose. For OncoGenomX, that purpose is simple — to give every patient the best possible chance at lasting response.
The Road Ahead
Our journey is just beginning. We are validating, scaling, and expanding across cancer types — from breast to prostate, lung, and beyond.
But our guiding principle remains unchanged: wherever there is cancer, there is a need for precision drug–tumour matching.
The convergence of genomics, phenomics, AI, and clinical data is redefining healthcare.
PredictionStar™ is part of that transformation — proving that predictive precision is not a futuristic concept, but an attainable standard.
We owe it to patients, to clinicians, and to science itself to make that standard universal.
In Closing
When I founded OncoGenomX, I imagined a world where no cancer patient has to live with uncertainty — where treatment is guided by prediction, not probability.
Today, that world feels within reach. PredictionStar™ is more than technology. It’s a promise:
That every patient deserves clarity. That every tumour can be understood.
And that, together, we can end the guesswork in cancer care.
Contact: Dr. Wolfgang Hackl | Founder & CEO, OncoGenomX | E-Mail | LinkedIn WH | Company Webpage | LinkedIn OGX
Pregnancy
Occupational therapy eases emotional strain of high-risk pregnancies, study finds

Occupational therapy can ease anxiety and emotional strain for women experiencing high-risk pregnancies, with cognitive-based techniques found to be most effective, new research has revealed.
Joint research from Edith Cowan University and the University of St Augustine for Health Sciences reviewed a range of psychosocial occupational therapy approaches and found that cognitive-based interventions had the strongest impact on managing perinatal anxiety, depression and stress.
The review examined several therapy types, including cognitive-based, counselling-based, sensory-based, emotion-based and integrated approaches.
Dr Thuy Tran is occupational therapy lecturer at Edith Cowan University’s School of Medical and Health Sciences.
The researcher said: “There is a lot of research evidence that reveals high-risk pregnancies result in increased levels of anxiety, stress, depression and a reduced quality of life.
“And while research has been done on how psychosocial occupational therapy could assist in those areas, there was no evidence which method was most effective.”
Around one in five women experience high-risk pregnancies requiring specialised monitoring and care.
Such pregnancies — which may involve conditions like pre-eclampsia, gestational diabetes or multiple births — often cause significant emotional distress, including fear, anxiety and uncertainty.
Occupational therapy helps people manage daily activities and life transitions through targeted interventions.
Psychosocial occupational therapy specifically addresses mental health and emotional wellbeing alongside functional support.
The researchers found that cognitive-based interventions were most effective for managing perinatal anxiety, depression and stress.
Counselling-based interventions had a moderate impact on anxiety, depression and quality of life, but a strong effect on reducing stress.
Sensory-based interventions appeared ineffective for anxiety, with limited evidence of impact on depression, stress or quality of life.
Lead author Dr Sabina Khan from the University of St Augustine for Health Sciences said the findings provide much-needed clarity about which approaches deliver the greatest benefit.
Khan said: “By identifying that cognitive-based and counselling-based interventions are the most effective in reducing anxiety, stress and depression, this research helps guide clinicians toward evidence-based practices that can meaningfully improve women’s wellbeing during a particularly vulnerable time.
“Women facing high-risk pregnancies frequently navigate fragmented systems.
“Embedding occupational therapy early helps close the gap between medical management and real-world function.”
Dr Tran said the research suggests practitioners should include cognitive-behavioural techniques in occupation-based sessions and place greater emphasis on emotional and cognitive assessment during the perinatal period.
The researcher said: “We need to have a holistic approach to working with clients to ensure that our strategies help them to function optimally.
“Whether this is in their new role as a mother, or their role as a mother to multiple children, or as a partner, or in their social role.”
The role of occupational therapists in women’s health is steadily growing in Australia.
Most practitioners work in private practice and are recognised as mental health care providers, making services accessible through mental health care plans, enhanced primary care plans or self-referral.
While some hospitals already employ occupational therapists in this field, there are calls for this to become standard care nationwide.
Dr Tran urged pregnant women, particularly those experiencing high-risk pregnancies, to seek intervention early.
Dr Tran said: “Pregnancy is such an intense phase, with women experiencing significant emotional, psychological and physical changes in their bodies, all while their social and work roles are also transitioning.
“A lot of focus is placed on the baby, but we don’t really talk about the emotional wellbeing of the mother and the transition from one role to the next.
“Having an occupational therapist can provide you with strategies to help that transition.”
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