Mon, Nov 10
• Final day of AHA Scientific Sessions 2025 in New Orleans — continued analyses of cardiometabolic and device data including Amgen’s VESALIUS-CV trial, which showed a 25% reduction in major adverse cardiovascular events (MACE) in primary prevention.
• Stifel 2025 Healthcare Conference opens in New York, spotlighting small- and mid-cap biotech and medtech outlooks.

Tue, Nov 11
• BioNTech R&D Day — focus on oncology and mRNA 2.0.
• KalVista and NeurAxis host Q3 earnings calls with key trial updates.

Wed, Nov 12
• Ascendis Pharma business update ahead of Navepegritide PDUFA (Nov 30) in achondroplasia.

Thu, Nov 13
• FDA Pediatric Advisory Committee reviews long-term safety across pediatric programs.

Through Month-End
• Watch for rare disease and endocrine FDA actions and continued readouts from fall conferences (AHA, IGCS, WCLC).

Johnson & Johnson’s CAPLYTA (lumateperone) Wins FDA Approval in MDD
The FDA approved CAPLYTA as adjunctive therapy for adults with major depressive disorder, expanding J&J’s neuroscience footprint and adding a differentiated mechanism to the antidepressant market. 👉 Read more

Darzalex Faspro (daratumumab/hyaluronidase-fihj) Moves Earlier in Myeloma
FDA cleared Janssen’s Darzalex Faspro for high-risk smoldering multiple myeloma, marking one of the first CD38 antibodies approved in a pre-symptomatic setting. 👉 Read more

Medicaid’s “Generous Model” Links U.S. Prices to Global Benchmarks
The new voluntary pricing program ties Medicaid drug costs to the lowest price among eight wealthy nations in exchange for standardized coverage and rebates starting in 2026. 👉 Read more

Pfizer and Novo Nordisk Escalate Bidding War Over Metsera
Pfizer reportedly outpaced Novo Nordisk in a bid for obesity-focused biotech Metsera, reinforcing how metabolic programs remain the hottest M&A frontier. 👉 Read more

Kimberly-Clark’s $40B Bet on Consumer Health
Kimberly-Clark’s acquisition of Kenvue, valued between $40–48.7 billion including debt, pushes its portfolio into branded OTC health and wellness — a clear signal that consumer health remains a safe harbor for long-term returns. 👉 Read more

New SCLC Maintenance Regimen Approved in the U.S.
FDA cleared a new maintenance combination for extensive-stage small cell lung cancer post first-line therapy, offering incremental survival gains in a difficult-to-treat population. 👉 Read more

TROP2 ADC Expansion Continues
Kelun-Biotech presented Phase 2 data for sacituzumab tirumotecan in advanced endometrial carcinoma, showing encouraging response rates and manageable safety. 👉 Read moreFive-Year KEYNOTE-775 Data Strengthen Lenvatinib + Pembrolizumab Durability
Eisai reported sustained long-term survival in advanced endometrial cancer at IGCS 2025. 👉 Read more

Gilead’s Lenacapavir: Recent Context
While the CHMP opinion and EC approval occurred in mid-2025, continued rollout discussions across EU member states keep twice-yearly lenacapavir in focus for PrEP adoption strategies. 👉 Read more

Amgen’s VESALIUS-CV Demonstrates 25% MACE Reduction
At AHA 2025, Repatha (evolocumab) achieved a 25% relative risk reduction in major adverse cardiovascular events in statin-treated, high-risk patients with no prior events — a landmark result redefining PCSK9 use in primary prevention. 👉 Read more

NICE Opens Consultation on Cemiplimab + Chemo in NSCLC
The UK’s NICE released draft guidance on Libtayo (cemiplimab) with platinum-based chemotherapy for advanced NSCLC, inviting stakeholder input on cost-effectiveness. 👉 Read more

AI Device Oversight Expands: FDA Requests Industry Input
FDA called for public comment on how to measure real-world performance and drift in AI-enabled medical devices, laying groundwork for post-market regulatory frameworks. 👉👉 Read more

AI-Designed Antibodies: Vanderbilt’s MAGE Model Breakthrough
Researchers unveiled a protein-language model capable of designing monoclonal antibodies from scratch, accelerating discovery timelines across biologics. 👉 Read moree

Merck KGaA’s SpringWorks Deal: Context Update
Although completed in July 2025, Merck KGaA’s $3.9B acquisition of SpringWorks Therapeutics continues to resonate, with integration milestones and pipeline readouts expected this quarter. 👉 Read more

Biotech Funding Resilience: Neok Bio Launches with $75M
The dual-targeting ADC company debuted amid tight capital markets, highlighting investors’ continued appetite for differentiated oncology platforms. 👉 Read more

IPO Drought Deepens
Fewer than 10 biotech IPOs have priced year-to-date, down more than 50% versus 2024. 👉 Read more

Device Sector Tightens Standards
Updated neurotechnology device standards take effect Nov 12, raising bar for safety and performance validation. 👉 Read more

U.S. Medicaid’s “Generous Model” — linking domestic prices to global references from 2026, impacting negotiation dynamics.

UK BioIndustry Association — 200 CEOs call for stronger R&D tax credits ahead of Autumn Budget.

WHO Global Health Financing Warning — urges governments to maintain primary care and outbreak funding amid donor pullbacks.

Rift Valley Fever — 404 cases and 42 deaths reported across Mauritania and Senegal.

PAHO Hurricane Response — emergency deployments underway across Caribbean islands following Hurricane Melissa.

AI and Digital Health Regulation Tighten
FDA and EU activity points to oversight maturity for AI-enabled devices.

Primary Prevention Gains Real-World Momentum
Repatha’s 25% MACE reduction gives cardiology its first major preventive benchmark beyond statins.

Pricing Reform Meets R&D Uncertainty
The “Generous Model” and UK funding appeals expose fault lines between innovation cost and political affordability.

M&A Up but Capital Scarce
Over $100 B in announced pharma/biotech deals year-to-date even as IPOs dry up.

Public Health Systems Under Stress
Climate, outbreak, and financing shocks keep resilience a front-line theme.

25% MACE reduction with Repatha in VESALIUS-CV (AHA 2025)

~109.50 USD — XBI ETF closes modestly higher week-over-week

<10 biotech IPOs in 2025 YTD

404 cases / 42 deaths — Rift Valley Fever outbreak

Stifel 2025 Healthcare Conference — Day 1 investor presentations (Spyre, Celcuity, NeurAxis).

AHA 2025 Final Day — ongoing VESALIUS-CV and heart-failure data analyses.

BioNTech R&D Day (Tue) — oncology and mRNA pipeline refresh.

XBI: ~109.50 USD (+0.5%)

IBB: 157.72 USD (−0.3%)

XLV: 146.14 USD (+0.4%)

LLY: 924.37 USD (−0.7%)

JNJ: 186.57 USD (flat)

Clarified Merck KGaA–SpringWorks and lenacapavir timing as context, not new events

Added 25% MACE reduction precision for VESALIUS-CV

Updated XBI ≈ 109.50 USD

Tightened section sequencing for narrative flow