News
FDA fast-tracks ovarian cancer drug

The US Food and Drug Administration (FDA) has granted fast track status to stenoparib, an ovarian cancer drug for patients who cannot tolerate platinum-based treatments.
The designation, given to medicines addressing serious medical needs, allows more frequent FDA communication and may enable accelerated approval if criteria are met.
Allarity Therapeutics is developing stenoparib as an option for women with advanced ovarian cancer who have hypersensitivity to platinum drugs such as cisplatin and carboplatin, or whose tumours no longer respond to these therapies.
Ovarian cancer begins in the reproductive organs that produce eggs.
While platinum drugs can shrink tumours and slow their growth, some patients cannot take them due to health complications or allergic reactions to the metal.
Thomas Jensen, chief executive officer of Allarit, said: “We are very pleased that the FDA has granted fast track designation to stenoparib.
“We look forward to engaging closely with the FDA as we advance this program.”
Jensen added that the designation “underscores the significant unmet need facing women with advanced ovarian cancer and reflects the potential of stenoparib to meaningfully improve treatment outcomes.”
Stenoparib, first developed by Eisai as E7449 and later called 2X-121, is an oral small molecule that blocks PARP1/2 and tankyrase 1/2 enzymes – proteins involved in cancer cell growth.
Blocking these enzymes is expected to slow tumour progression.
A Phase 1 clinical trial (NCT01618136) showed stenoparib as an add-on treatment was well tolerated and prolonged survival in patients with solid cancers, including five with ovarian cancer.
Phase 1 trials test safety and dosing in small groups.
Allarity is now enrolling patients in a Phase 2 study to determine the best dose – 600mg or 800mg daily as hard gelatin capsules – for women with advanced, recurrent ovarian cancer who cannot take platinum drugs or whose tumours are resistant.
Phase 2 trials test effectiveness in larger patient groups.
Several patients have been receiving treatment since June. The study will measure clinical benefit, progression-free and overall survival, disease control, and response rates over about two years.
The company is using its Drug Response Predictor (DRP) platform to identify patients whose tumour genetics suggest they are likely to respond to stenoparib.
DRP also helps identify biomarkers of response or resistance to treatment.
Fast track designation may also give access to accelerated approval, priority review, or rolling review, potentially bringing the drug to patients more quickly than standard processes.
Pregnancy
Pregnancy complications may increase risk for artery disease, study finds

Pregnancy complications may increase women’s risk of peripheral artery disease later in life, new research suggests.
The study analysed data from more than two million women in Sweden who gave birth to single babies between 1973 and 2015.
Led by Casey Crump, the research examined the long-term risk of peripheral artery disease among women who experienced preterm delivery, pre-eclampsia, gestational diabetes or other adverse pregnancy outcomes.
Crump, professor in the department of family and community medicine at McGovern Medical School at UTHealth Houston, said: “Our prior work has already shown that adverse pregnancy outcomes are associated with long-term risks of heart disease, stroke, and heart failure.
“This study builds on that work by showing that these women have an increased risk of peripheral artery disease, an important but understudied cardiovascular condition.”
Peripheral artery disease is often a precursor to long-term cardiovascular complications, including stroke, ischaemic heart disease and premature death.
The condition affects millions of people worldwide and occurs when narrowed arteries reduce blood flow, most commonly to the legs and feet.
Ischaemic heart disease occurs when the heart does not receive enough blood and oxygen, usually because the arteries have narrowed.
Symptoms of peripheral artery disease can include leg pain, cramps while walking, numbness, cold feet and sores on the feet or legs that are slow to heal.
Crump said women who experience pregnancy complications have an important opportunity after giving birth to make plans with their primary care doctor to monitor long-term risks.
Women who have experienced complicated pregnancies should speak with their doctor about possible future cardiovascular health risks.
Checks for blood pressure, diabetes and cholesterol are important.
While the period after childbirth is an important time for women to monitor their health, Crump said it is never too late to lower the risk of peripheral artery disease.
He said: “Women with a history of adverse pregnancy outcomes who seem to be doing well may still have a higher risk that can emerge later in life.”
Crump also suggested preventive steps such as avoiding smoking, maintaining a healthy weight and following a healthy lifestyle.
He stressed the importance of long-term follow-up care and conversations with healthcare providers to help protect cardiovascular health later in life.
Hormonal health
PMOS could increase heart disease risk, study finds

Women with PMOS may have a fourfold higher risk of heart disease, new research suggests.
PMOS, or polyendocrine metabolic ovarian syndrome, is a complex hormone condition affecting about one in eight women in the UK.
It can affect hair growth, periods, fertility and mood.
US researchers analysed health insurance data collected between 2000 and 2022 from 413,450 women with PMOS aged 18 to 50.
They compared the group with more than two million women who did not have the condition.
The study found that women with PMOS had a fourfold higher risk of heart disease than those without it.
The increased risk remained after researchers accounted for other factors linked to heart disease, including high blood pressure and diabetes.
International PMOS guidelines recommend screening all patients for heart disease risk at diagnosis and providing advice on lifestyle changes.
However, researchers said patient surveys “report delayed diagnosis and substantial dissatisfaction with counselling regarding long-term comorbidities”.
Comorbidities are additional health conditions that occur alongside a main condition.
Researchers added: “Our results emphasise the need for physician education and patient awareness of cardiovascular disease risk to improve implementation of early preventive interventions.”
The team called for further studies following women through menopause, when periods stop.
They also called for research into whether treatments such as GLP-1 drugs or hormonal contraception affect the link between PMOS and heart disease.
GLP-1 drugs are medicines used for conditions including type 2 diabetes and weight management.
The main symptoms of PMOS include irregular periods or long gaps between periods, excessive hair growth or hair loss, weight gain or difficulty losing weight, and difficulty becoming pregnant.
Other symptoms include depression or anxiety, oily skin and acne, tiredness, and thick, dark patches of skin on the neck or armpits, known as acanthosis nigricans.
Until recently, PMOS was known as polycystic ovarian syndrome, or PCOS.
Experts called for the name change after highlighting that misunderstandings about cysts and too much focus on the ovaries were delaying diagnoses.
Earlier this month, the National Institute for Health and Care Excellence said women with PMOS should be seen by health professionals annually to monitor symptoms and manage long-term risks.
NICE said the condition affects between three and four million women in the UK but is “frequently underdiagnosed and inconsistently managed”.
News
Zero Candida market set to reach over US$2 billion by 2030 – report

A market analysis made by Moore Financial Consulting estimates the global market for Zero Candida Technologies, Inc. (TSXV: ZCT) (OTCQB: ZCTFF) (FSE: 9L2) (the “Company” or “ZCT”), a FemTech medical device company advancing next-generation solutions for women’s health, will reach over USD 2 billion by 2030, with a compound annual growth rate of 5.25 per cent globally and 3.9 per cent in North America and 4.2 per cent in Europe.
The analysis emphasis that up to 75 per cent of women will have at least one vaginal yeast infection in their life.
Moreover, recurrent VVC (Vulvovaginal Candidiasis) affects nearly 8 per cent of women globally (for women above the ages of 15-60).
According to the data, 100 per cent of women with Recurrent VVC will purchase a combination of over-the-counter and prescription antifungal treatments, usually with the common use of oral agents.
Compared to women with non-recurrent VCC, 55.2 per cent will purchase prescription antifungal treatment, 37 per cent over-the-counter antifungal, 5.6 per cent will purchase a combination of both treatments, and the rest will not purchase any treatment.
Eli Ben Haroosh, founder & CEO, Zero Candida Technologies, said: “Moore’s market analysis matches our estimations, Zero Candida is a groundbreaking and game-changing company in the world of women’s medicine, and we look forward to be one of the leading companies offering AI-driven, tampon-like device, helping women suffering from VVC .
Zero Candida announced recently that its shares are now successfully listed on the Frankfurt Stock Exchange (FSE).
This listing marks a significant milestone for the Company as it expands its global presence, now cross-listed on both the TSX Venture Exchange and the FSE, providing increased visibility and access to a broader pool of international investors.
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