This video summary includes developments across women’s health highlighting FDA approvals, clinical breakthroughs, strategic investments, and emerging disease insights. Key updates cover Teva’s UZEDY (risperidone) SC extended-release approval for bipolar I maintenance, BioNxt’s US Track One patent filing for sublingual cladribine, and Gilead’s settlement-driven delay of Biktarvy generics to 2036. We also review Zenas Biopharma’s licensing of orelabrutinib and immunology assets from InnoCare, Roche–Lilly’s FDA clearance of the Elecsys pTau181 Alzheimer’s blood test, and Datopotamab deruxtecan’s first-line OS and PFS benefit in TROPION-Breast02. Additional highlights include Novartis survey insights on breast health conversations, the Women’s Health Fund’s market-building initiatives, rising lobular breast cancer incidence, and new findings on higher genetic depression risk in women, underscoring trends likely to shape prescriber decisions, payer evaluations, and pipeline investments.
Watch Our Video Summary Capturing Women’s Health News from the Last Two Weeks
💉 FDA expands UZEDY (risperidone) to maintenance in adult bipolar I [1] [10 Oct 2025]
https://www.tevapharm.com/news-and-media/latest-news/fda-approves-expanded-indication-for-uzedy-risperidone-extended-release-injectable-suspension-as-a-tre/
• Context: UZEDY SC extended-release risperidone uses SteadyTeq; approved in schizophrenia since 2023.
• Key point: FDA OKs once-monthly UZEDY as mono- or adjunctive therapy to lithium or valproate for BD-I maintenance, with three monthly dose options.
• Implication: May influence prescriber choice and payer reviews pending full data.
♀️ Women’s Health Fund targets market-building at scale [2] [14 Oct 2025]
https://insights.citeline.com/in-vivo/leadership/deliberate-market-building-is-next-step-to-close-the-womens-health-gap-GNWHD574I5BIVNL42ISBZRAUFE/
• Context: “Fund of funds” launched at WHIE Forum Berlin; backers include AHA Go Red, SWHR, 1843 Capital, Gates-aligned groups.
• Key point: Aims to catalyze large, durable capital allocation beyond fertility, into conditions that affect women differently or disproportionately.
• Implication: Signals pipeline investment and modality expansion.
🗣️ Novartis survey: breast health conversations remain constrained [3] [07 Oct 2025]
https://www.fiercepharma.com/marketing/novartis-survey-shines-light-hidden-realities-womens-conversations-about-breast-health
• Context: Harris Poll of >3,000 US women with and without breast cancer.
• Key point: Despite high self-reported knowledge, few perform monthly self-exams and many feel societal pressure limits dialogue.
• Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🧬 Gilead delays US Biktarvy generics to 2036 via settlements [4] [07 Oct 2025]
https://www.fiercepharma.com/pharma/gilead-notches-settlements-three-generic-drugmakers-waylaying-us-biktarvy-copycats-until
• Context: Deals with Lupin, Cipla, Laurus after ANDAs filed.
• Key point: Settlements push earliest US generic entry to Apr 1, 2036, beyond prior 2033 expectation.
• Implication: Introduces competition that may affect pricing and formulary access.
🤝 Zenas licenses orelabrutinib and 2 assets from InnoCare, raises $120M [5] [08 Oct 2025]
https://investors.zenasbio.com/news-releases/news-release-details/zenas-biopharma-and-innocare-pharma-announce-license-agreement
• Context: BTK inhibitor orelabrutinib in PPMS Phase 3; SPMS Phase 3 planned 1Q26; IL-17AA/AF and brain-penetrant TYK2 in IND-enabling.
• Key point: Zenas gains global non-oncology rights to orelabrutinib and additional rights to two oral immunology candidates; milestones exceed $2B potential.
• Implication: Signals pipeline investment and modality expansion.
🧪 Datopotamab deruxtecan hits OS and PFS in 1L TNBC (TROPION-Breast02) [6] [06 Oct 2025]
• Context: 644-patient Phase 3 vs investigator’s choice chemo in mTNBC not eligible for IO.
• Key point: Statistically significant, clinically meaningful OS and PFS benefit, supporting first-line positioning.
• Implication: May influence prescriber choice and payer reviews pending full data.
💊 BioNxt files US Track One patent for sublingual cladribine (MS) [7] [09 Oct 2025]
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/bionxt-completes-%22fast-track%22-us-track-one-patent-filing-for-sublingu-1084504
• Context: BNT23001 thin-film cladribine; global nationalizations underway with positive EPO/EAPO signals.
• Key point: Fast-track filing seeks near-term US IP for sublingual cladribine aimed at improved bioavailability and adherence.
• Implication: Signals pipeline investment and modality expansion.
🧠 WHO Foundation and Lilly collaborate on global dementia plan [8] [13 Oct 2025]
https://investor.lilly.com/news-releases/news-release-details/who-foundation-and-lilly-collaborate-support-global-dementia
• Context: Support spans risk reduction, early detection, diagnosis and care.
• Key point: Collaboration provides financial resources for WHO efforts as systems prepare for earlier Alzheimer’s detection and treatment.
• Implication: May expand screening, initiation, and follow-up at scale.
🧪 FDA clears Roche–Lilly Elecsys pTau181 blood test for Alzheimer’s aid [9] [13 Oct 2025]
https://www.marketscreener.com/news/roche-lilly-s-blood-test-for-alzheimer-s-diagnosis-gets-us-approval-ce7d5ad8d189f124
• Context: Intended for adults ≥55 with cognitive decline; negative predictive value 97.9% in 312-participant study.
• Key point: Clearance as an aid to initial assessment could speed access to anti-amyloid therapies via scalable lab platforms.
• Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
📈 Lobular breast cancer incidence rising faster than other types [10] [08 Oct 2025]
https://www.newsweek.com/lesser-known-breast-cancer-surging-in-us-report-warns-10847301
• Context: ACS projections highlight ILC trends, subtype biology and survival patterns.
• Key point: ILC growing at 2.8% per year vs 0.8% for all breast cancers combined from 2012–2021; later survival disadvantage in advanced stages.
• Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🧬 Study: higher genetic risk burden for depression in women [11] [07 Oct 2025]
https://www.theguardian.com/science/2025/oct/07/women-carry-a-higher-genetic-risk-of-depression-new-study-says
• Context: Nature Communications analysis of international cohorts with sex-stratified GWAS.
• Key point: 16 variants linked to depression in women vs 8 in men; stronger female genetic correlations with metabolic traits.
• Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
Why it matters
• Diagnostics are shifting earlier, from blood-based AD tests to survey-driven patient support needs in breast cancer.
• First-line oncology ADC data and extended HIV exclusivity reshape competitive timelines and access.
• CNS pipeline and delivery innovation, from LAI risperidone in BD-I to sublingual cladribine, target adherence and system capacity.
• Women’s health financing is pivoting from niche to market-building, widening the innovation aperture beyond fertility.
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FAQ
What did FDA add to UZEDY’s label in BD-I?
UZEDY is now approved as once-monthly SC monotherapy or adjunct to lithium/valproate for maintenance in adult bipolar I, expanding beyond schizophrenia [1].
How far did Gilead extend Biktarvy’s US runway?
Settlements with Lupin, Cipla and Laurus defer US generics to Apr 1, 2036, pushing beyond the prior 2033 expectation [4].
What is the significance of the TROPION-Breast02 readout?
Datopotamab deruxtecan showed OS and PFS benefit vs chemo in 1L mTNBC not eligible for IO, bolstering first-line ambitions [6].
How could Elecsys pTau181 change AD workflows?
FDA clearance as an aid to initial assessment enables broad lab deployment, potentially accelerating triage to confirmatory testing and therapy access [9].
What rights did Zenas secure from InnoCare?
Global non-oncology rights to orelabrutinib in MS, plus ex-Greater China rights to an oral IL-17AA/AF inhibitor and global rights to a brain-penetrant TYK2 inhibitor, alongside $120M financing [5].
Why highlight lobular breast cancer now?
ACS data indicate faster incidence growth and poorer long-term survival at advanced stages vs ductal cancers, underscoring subtype-specific research and detection needs [10].
Entities / Keywords
Teva; MedinCell; UZEDY; risperidone LAI; Women’s Health Fund; AHA Go Red; Gates Foundation; Novartis; breast health survey; Gilead; Biktarvy; AstraZeneca; Daiichi Sankyo; datopotamab deruxtecan; TNBC; BioNxt; cladribine thin-film; Lilly; WHO Foundation; Roche; Elecsys pTau181; Alzheimer’s; American Cancer Society; invasive lobular carcinoma; QIMR Berghofer; depression genetics.
References
1. https://www.tevapharm.com/news-and-media/latest-news/fda-approves-expanded-indication-for-uzedy-risperidone-extended-release-injectable-suspension-as-a-tre/
2. https://insights.citeline.com/in-vivo/leadership/deliberate-market-building-is-next-step-to-close-the-womens-health-gap-GNWHD574I5BIVNL42ISBZRAUFE/
3. https://www.fiercepharma.com/marketing/novartis-survey-shines-light-hidden-realities-womens-conversations-about-breast-health
4. https://www.fiercepharma.com/pharma/gilead-notches-settlements-three-generic-drugmakers-waylaying-us-biktarvy-copycats-until
5. https://investors.zenasbio.com/news-releases/news-release-details/zenas-biopharma-and-innocare-pharma-announce-license-agreement
6. https://www.europeanpharmaceuticalreview.com/news/266702/astrazeneca-daiichi-sankyo-datroway-phase-iii-breast-cancer-clinical-trial/
7. https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/bionxt-completes-%22fast-track%22-us-track-one-patent-filing-for-sublingu-1084504
8. https://investor.lilly.com/news-releases/news-release-details/who-foundation-and-lilly-collaborate-support-global-dementia
9. https://www.marketscreener.com/news/roche-lilly-s-blood-test-for-alzheimer-s-diagnosis-gets-us-approval-ce7d5ad8d189f124
10. https://www.newsweek.com/lesser-known-breast-cancer-surging-in-us-report-warns-10847301
11. https://www.theguardian.com/science/2025/oct/07/women-carry-a-higher-genetic-risk-of-depression-new-study-says