Women’s Health Video Recap—January 7, 2026

This Women’s Health video roundup brings together key regulatory decisions, clinical trial outcomes, AI-enabled diagnostics, and policy changes shaping women’s care pathways

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Transcript

Welcome to the latest edition of Women’s Health Updates, covering breakthroughs in the past two weeks. Brought to you by LucidQuest.

AHA’s Go Red for Women Venture Fund invested in Ultromics’ EchoGo Heart Failure, an FDA-cleared, outcome-trained AI used across the US and UK, to strengthen HFpEF detection on echocardiography. Amount undisclosed.

In the EU, AstraZeneca’s Saphnelo, anifrolumab, gained approval for subcutaneous self-administration via a pre-filled pen for adults with SLE on standard therapy, supported by TULIP-SC with safety consistent with IV. This enables at-home use and may scale screening, initiation, and follow-up.

In the UK, NICE recommended natalizumab, both originator Tysabri and biosimilar Tyruko, for adults with highly active RRMS after at least one prior DMT when cladribine is unsuitable, adding competition that could affect pricing and access.

In the US, FDA issued a Complete Response Letter for Sanofi’s tolebrutinib NDA in non-relapsing SPMS. The company will engage the agency on a path forward, and prescribing and payer decisions may await full data.

Biohaven reported BHV-7000 failed to show efficacy over placebo in a 6-week Phase 2 MDD study using MADRS, with subgroup trends non-confirmatory, and will deprioritize psychiatry while focusing on epilepsy, immunology, and obesity.

Axsome said FDA accepted, with Priority Review, the sNDA for AXS-05 for Alzheimer’s disease agitation, based on four Phase 3 trials plus long-term safety, with a PDUFA date of 30 Apr 2026.

Thermo Fisher’s PPD CorEvitas Alzheimer’s Disease Registry enrolled its first patient. This multi-country longitudinal effort will collect clinician-reported data to generate regulatory-grade real-world evidence on safety, treatment patterns, and outcomes.

Continuem’s VISTA Phase 2 trial of remyelinating agent PIPE-307 in RRMS, 168 patients over 30 weeks, did not meet the prespecified primary endpoint of low-contrast letter acuity change. Exploratory and prespecified analyses are planned.

China ended the VAT exemption on contraceptives on 01 Jan 2026, imposing a 13% VAT while exempting certain childcare, marriage, and elder-care services, a pronatalist policy shift that has drawn skepticism on effectiveness.

Finally, in oncology, the FDA approved Enhertu, trastuzumab deruxtecan, with pertuzumab as first-line therapy for metastatic HER2-positive breast cancer, an approval ahead of deadline and supported by NEJM data versus the THP standard.
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Why It Matters

EU self-admin routes and NICE biosimilar adoption expand patient choice and may lower costs in SLE and RRMS.
CNS development remains high risk, with psychiatry and remyelination programs challenged by placebo and endpoint selection.
Alzheimer’s care is pivoting to real-world data capture while potential symptomatic options like AXS-05 advance.
Frontline approval of Enhertu combinations could reset HER2+ metastatic breast cancer standards.

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FAQ

What did NICE change for MS treatment?

NICE recommended natalizumab (Tysabri, Tyruko) for adults with highly active RRMS after at least one DMT when cladribine is unsuitable, adding a cost-effective option via biosimilar use [3].

What is new for Saphnelo in Europe?

The EC approved a subcutaneous, self-administered pre-filled pen for adult SLE, supported by TULIP-SC, with safety consistent with IV infusion [2].

Why is tolebrutinib not moving forward in the US now?

FDA issued a CRL for Sanofi’s nrSPMS filing. Sanofi intends to work with the agency while reviews continue elsewhere [4].

How significant is the Enhertu frontline decision?

FDA approval of Enhertu plus pertuzumab in first-line HER2-positive metastatic breast cancer, based on superiority vs THP, may shift US practice pending guideline uptake [10].

What is included in Axsome’s AXS-05 filing?

The sNDA for Alzheimer’s agitation has Priority Review and is supported by four Phase 3 trials plus long-term safety data; decision goal date 30 Apr 2026 [6].

Entities / Keywords

Ultromics EchoGo HFpEF; AstraZeneca Saphnelo anifrolumab SC; NICE, natalizumab Tysabri, Tyruko biosimilar, RRMS; Sanofi tolebrutinib nrSPMS CRL; Biohaven BHV-7000 MDD; Axsome AXS-05 Alzheimer’s agitation Priority Review; Thermo Fisher PPD CorEvitas Alzheimer’s Registry; Continuem PIPE-307 RRMS remyelination; China contraception VAT policy; Enhertu trastuzumab deruxtecan + pertuzumab 1L HER2+ mBC.