Women's College Hospital

Postpartum depression (PPD) affects up to one in five Canadian women 1 ; it is the most common complication 2 related to childbearing and a leading cause of maternal death in Canada 3 Left untreated, PPD can have short- and long-term consequences on maternal health, child development and family well-being 4,5,6 ZURZUVAE is a 14-day, oral single course of treatment that offers relief from depressive symptoms as early as Day 3, a significant step forward from the current standards of PPD care TORONTO--(BUSINESS WIRE)--Biogen Canada Inc. today announced that Health Canada has issued a Notice of Compliance (NOC) for ZURZUVAE™ (zuranolone) for the treatment of moderate or severe postpartum depression (PPD) in adults following childbirth. ZURZUVAE is a once-daily, 14-day oral single course treatment for women with PPD. This first-of-its-kind treatment offers relief from depressive symptoms, with benefits seen in clinical studies as early as day 3, significant reduction of symptoms by the end of treatment at Day 15, and sustained effect through day 45 compared to placebo. ZURZUVAE offers a novel therapeutic approach due to its onset as early as Day 3 and a targeted mode of action that addresses mood dysregulation thought to be related to the significant hormone fluctuations after childbirth7,8. Unlike traditional antidepressants, which target serotonin pathways, ZURZUVAE modulates the activity of gamma-aminobutyric acid A (GABAA) receptors in the brain, whose signaling is involved in the regulation of mood7,8. By enhancing the activity of GABA, ZURZUVAE may help restore function in the dysregulated parts of the brain causing depressive symptoms.8,9 “A treatment developed specifically for postpartum depression marks an important step forward for maternal mental health,” said Dr. Crystal Clark, MD, MSc, Canada Research Chair in Reproductive Mental Health and Associate Head of Research, Department of Psychiatry, Women’s College Hospital. “Postpartum depression is often driven by profound hormonal shifts that occur during and after childbirth, and expanding treatment options with a therapy designed to address the impact of these biological changes on mental health addresses a longstanding gap in medical care. For postpartum individuals — who are caring for a newborn while managing major hormonal, physiological, and life transitions — ZURZUVAE offers a quick-acting, 14-day treatment, and new hope for reducing the debilitating burden of depression and improving family outcomes." PPD is a common, serious maternal mental health issue that starts during or after pregnancy.9 Symptoms may include depressed mood, anxiety, functional impairment of daily activities, feelings of guilt and worthlessness, doubts about motherhood, and thoughts of self- or infant harm.4 It can have debilitating short- and long-term impacts on both the mother and child. Left untreated, PPD can affect a mother and baby’s ability to bond, impacting the baby’s sleep, feeding, and long-term development, and is linked to a higher risk of anxiety and depression later in life.4 PPD also has a ripple effect on families and society with links to lower marital satisfaction, higher separation rates9, 10, as well as higher levels of stress, anxiety and depression in partners.4 “There are notable gaps across the country with respect to the diagnosis, treatment and care of post-partum depression, which can have a devastating impact on mothers and families,” said Claire Zlobin, Founder, Life With a Baby. “We must make maternal mental health a national priority and elevate the standards of care. Ignoring these issues costs Canada over an estimated $6 billion in healthcare, social services and lost productivity costs each year.11 We welcome the news of a new treatment option specifically developed for post-partum depression as an important step in supporting mothers and babies.” The approval of ZURZUVAE is based on the NEST clinical development program, which included the ROBIN and SKYLARK studies. Both studies met their primary endpoint, a significant mean reduction from baseline in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score, a common measure of depression severity, at Day 15 as compared to placebo. The SKYLARK study additionally showed statistically significant reduction in depressive symptoms seen as early as Day 3 and sustained through Day 45 compared to placebo. ZURZUVAE was generally well-tolerated with a consistent safety profile across both studies. The most frequently reported side effects ≥ 10% in ZURZUVAE (50mg) and > 2% than placebo were somnolence, dizziness, and sedation. “This approval addresses a critical unmet need for Canadian mothers, marking an important step in elevating how we treat what can be a devastating maternal health issue,” said Eric Tse, General Manager, Biogen Canada Inc. "To any mother experiencing postpartum depression, prompt symptom relief and return to more normal functioning is critical. For the first time, mothers will have access to effective treatment, specifically indicated for PPD. This innovation builds on Biogen’s proven history of pioneering first-in-class treatments for unmet medical needs, and we are working collaboratively with decision-makers across Canada to enable timely access to ZURZUVAE.” ZURZUVAE is available in the U.S. with coverage through most major insurers12. The U.S. Food and Drug Administration (FDA) approved ZURZUVAE in August 2023 and the Drug Enforcement Agency (DEA) scheduled it as a Class IV controlled substance in October 2023. ZURZUVAE received regulatory approvals in the U.K. by the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Commission in August and September 2025, respectively. About ZURZUVAE ™ (zuranolone) ZURZUVAE™ is a neuroactive steroid (NAS) that acts as a positive allosteric modulator of GABA-A receptors, enhancing inhibitory signalling in the brain. The GABA system is the major inhibitory signaling pathway of the central nervous system and contributes to regulating brain function. ZURZUVAE was discovered by Sage Therapeutics, Inc., and in 2020 Biogen and Sage Therapeutics entered into a collaboration to jointly develop and commercialize ZURZUVAE in the U.S. As part of the agreement, Biogen received exclusive rights to develop and commercialize ZURZUVAE outside of the U.S., excluding Japan, Taiwan and South Korea. In July 2025, Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN) completed its acquisition of Sage Therapeutics and is now the collaboration partner with whom Biogen is working in the U.S. About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment, to deliver long-term growth. Biogen has been proudly serving Canadian patients for more than 25 years. For information about Biogen Canada, please visit www.biogen.ca. References: Vigod SN, Frey BN, Clark CT, Grigoriadis S, Barker LC, et al. Canadian Network for Mood and Anxiety Treatments 2024 clinical practice guideline for the management of perinatal mood, anxiety, and related disorders. Canadian Journal of Psychiatry. 2025. Available at: https://journals.sagepub.com/doi/full/10.1177/07067437241303031 . Centre for Addiction and Mental Health. Postpartum Depression: Clinical Overview. 2025. Available at: https://www.camh.ca/-/media/files/ppd_clinical_overview-pdf.pdf . Campbell, J., Cuthbert, C., Deave, T. et al. J. Women’s Health 30, 236–244 (2021) Moore Simas TA, Huang M-Y, Patton C, Reinhart M, Chawla AJ, Clemson C, Eldar-Lissai A. The humanistic burden of postpartum depression: a systematic literature review. Current Medical Research and Opinion. 2019;35(3):383-393. Available at: https://doi.org/10.1080/03007995.2018.1552039 . Rogers A, Holbrook K, et al. Association between maternal perinatal depression and anxiety and child and adolescent development: a meta-analysis. JAMA Pediatrics. 2020;174(11):1082-1092. Available at: https://jamanetwork.com/journals/jamapediatrics/fullarticle/2770120 . Goodman JH. Paternal postpartum depression, its relationship to maternal postpartum depression, and implications for family health. Journal of Advanced Nursing. 2004;45(1):26-35. Available at: https://onlinelibrary.wiley.com/doi/abs/10.1046/j.1365-2648.2003.02857.x. Maguire J. Neuroactive steroids and GABAergic involvement in the neuroendocrine dysfunction associated with major depressive disorder and postpartum depression. Frontiers in Cellular Neuroscience. 2019. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC6418819/ . Letourneau NL, Dennis CL, Benzies K, Duffett-Leger L, Stewart M, Tryphonopoulos PD, Este D, Watson W. Postpartum depression is a family affair: addressing the impact on mothers, fathers, and children. Issues in Mental Health Nursing. 2012;33(7):445-457. Available at: https://pubmed.ncbi.nlm.nih.gov/22757597/ . Kerstis B, et al. Association between parental depressive symptoms and impaired bonding with the infant. Archives of Women’s Mental Health. 2016;19(1):87-94. Available at: https://pubmed.ncbi.nlm.nih.gov/25854998/ . Canadian Perinatal Mental Health Collaborative. Time for action: Why Canada needs a national perinatal mental health strategy now more than ever. Ottawa, Canada: Canadian Perinatal Mental Health Collaborative; 2021. 48 p. Policy Center for Maternal Mental Health. One year later: How insurers are covering Zurzuvae, the first postpartum depression pill. 2024. Available at: https://policycentermmh.org/one-year-later-how-insurers-are-covering-zurzuvae-the-first-postpartum-depression-pill/ .

LONDON, UNITED KINGDOM, November 7, 2025 / EINPresswire.com / -- One of the world’s leading radiologists, Professor Dorothy Ibifuro Makanjuola , has called for urgent action to end the stigma surrounding male breast cancer, warning that lack of awareness and late diagnosis are costing lives. In conversation with The European, she explains why men must be part of the fight — and how simple vigilance could save thousands Male breast cancer is still “overlooked, under-discussed and diagnosed too late” because too many men feel embarrassed to seek help or even admit the disease exists, according to one of the world’s leading radiologists. Professor Dorothy Makanjuola, the Director of Women’s Imaging at the Women’s Hospital in King Abdul Aziz Medical City, Riyadh, warns that awareness campaigns and medical training must finally give it the same attention as women’s breast cancer. In an interview with The European, she said hundreds of men each year are dying unnecessarily from a disease that is still widely perceived as a women’s illness. “Our males are dying because they are not diagnosed early,” she said. “And this is wrong.” While breast cancer in men accounts for roughly one per cent of all cases, the consequences of late diagnosis are often fatal. Each year, around 390 men in the UK and nearly 2,800 in the United States are diagnosed; most are treated only once the cancer has advanced. Makanjuola said the gendered perception of the disease prevents men from recognising symptoms and deters them from seeking help. “They feel embarrassed because it’s not widely known,” she added. “But awareness, awareness, awareness — and you’ll find it’s like any other cancer.” Speaking to Juliette Foster, Makanjuola called for a change in public messaging to include men in breast-cancer awareness campaigns, suggesting that the familiar pink ribbon be replaced with a combined pink-and-blue symbol. “When people ask why you’re wearing pink and blue, you can say it affects men too,” she explained. “You don’t want to give the wrong impression that this is exclusively female.” Makanjuola, who holds an MBBS from the University of Ibadan and postgraduate radiology qualifications from Edinburgh and London, said both genetic and lifestyle factors contribute to risk. Excess oestrogen, whether from hormonal imbalance, obesity, alcohol, liver disease, or the genetic disorder Klinefelter syndrome, increases vulnerability, as does a family history of breast or ovarian cancer linked to the BRCA2 gene. She added that awareness must extend beyond the public to medical professionals themselves. “Medical knowledge is so wide — it’s difficult to know everything,” she said. “Some general practitioners may not recognise the symptoms because it’s so rare.” For that reason, she believes male breast cancer should feature more prominently in GP training and continuing education to reduce delays in referral and treatment. Currently, there is no routine screening programme for men, a gap she described as a serious weakness, since self-examination is often the only line of defence. “Men checking their breast tissue is even more important than for females because they don’t have any screening programme,” she said. “We rely entirely on them to check themselves monthly.” She advised men to look for changes in the nipple, chest wall, and armpit — including lumps, discolouration, or discharge — and to seek medical advice immediately if abnormalities persist. Older men, she said, face the highest risk, and those with BRCA2 should be offered regular screening. Emerging technologies may also improve early detection. Makanjuola highlighted ongoing research into AI-powered ultrasound imaging and so-called “liquid biopsy” techniques capable of detecting molecular traces of cancer in the bloodstream. Such methods, she said, could one day bridge the diagnostic gap for men who currently fall outside national screening frameworks. She also urged survivors to play a central role in raising awareness, arguing that their voices could reach sceptical or reluctant audiences. “Male breast-cancer survivors would be the best advocates,” she said. “If they join in the awareness, men will be convinced that they should take care.” Despite the challenges, Makanjuola remains hopeful. “Start with pink-and-blue ribbons and you’ll be surprised how many people will ask why,” she said. “The more we talk about it, the closer we get.” Watch the full interview with Professor Dorothy Makanjuola on The European’s YouTube channel and the-european.eu . Jonathan Edwards CP Media Global Limited email us here Visit us on social media: YouTube X Other Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. 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Our study suggests that CercaTest® RED could offer significant value in early detection in clinical settings and at home for early intervention, thereby improving maternal and fetal outcomes.” — Dr. Xiaoxia Bai, Zhejiang University Women's Hospital DEQING, CHINA, November 3, 2025 / EINPresswire.com / -- Shuwen Biotech , an integrated in vitro diagnostic (IVD) company today announced that results from a prospective clinical study on CercaTest RED™ was presented in the Asia Pacific Congress in Maternal Fetal Medicine 2025 (APCMFM) held from November 1 to 3 in Osaka, Japan. The Asia-Pacific Congress of Maternal-Fetal Medicine (APCMFM) is one of the most influential academic conferences in the field of maternal fetal medicine in the Asia-Pacific region. CercaTest RED™ is a patent-protected point-of-care test for detection of misfolded proteins in urine samples to aid in the diagnosis and screening of preeclampsia after the 20th week of pregnancy. Preeclampsia is a hypertensive syndrome that complicates 2 to 8% of all pregnancies and accounts for about 70,000 maternal deaths and 500,000 fetal or newborn deaths each year worldwide. CercaTest RED™ is non-invasive and easy to use, providing results within 10 minutes. It is a CE marked product, and has been approved in China for both professional and home testing. During the first day of the Conference, Dr. Xiaoxia Bai from Women’s Hospital of Zhejiang University School of Medicine presented a multicenter prospective longitudinal study using CercaTest RED™ involving 365 women suspected of having preeclampsia. When the CercaTest RED™ test results were combined with clinical parameters into a prediction model, a high accuracy was demonstrated in predicting preeclampsia within one week of clinical diagnosis, with an AUC 0.937 (95 % CI 0.911–0.964), PPV 54.4 % (95 % CI 44.3–63.7 %) and NPV 97.7 % (95 % CI 95.3–99.1 %). For severe preeclampsia the AUC rose to 0.955. “CercaTest RED™ is a urine-based one-step test that can be performed by pregnant women or professionals with almost instant result,” said Dr. Xiaoxia Bai, “Our study suggests that it could offer significant value in early detection in clinical settings and at home for early intervention, thereby improving maternal and fetal outcomes.” About Shuwen Biotech Shuwen Biotech is an integrated diagnostic company with offices in China and Germany. Founded on the principles of innovation, patent protection, and international collaboration, Shuwen established strategic partnerships with leading academic and commercial institutions to commercialize first-in-class diagnostic technologies and patents, and has developed a range of novel diagnostics in the fields of cancer and women’s health. Shuwen has also developed quality companion diagnostics and provides central lab biomarker testing services to leading pharmaceutical developers and hospitals. Shuwen houses an in-house development team, CAP-accredited central labs, and GMP/ISO13485-certified IVD manufacturing facilities, all in line with global standards to continue to deliver transformational products and services to its customers globally and open new possibilities in the advancement of health. Innovative products are offered on the international market through Cerca Biotech GmbH ( www.cercabiotech.com ), Shuwen’s European subsidiary in Berlin. Jay Z. Zhang Shuwen Biotech Co. Ltd. email us here Visit us on social media: LinkedIn YouTube Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.