FDA Names Richard Pazdur as CDER Director
Longtime oncology leader Dr. Richard Pazdur was appointed Director of the Center for Drug Evaluation and Research (CDER), consolidating oncology-style speed with evidence rigor across all therapeutic areas. 👉 Read more
Context: Expect ripple effects on surrogate-endpoint acceptance and post-marketing evidence standards as his framework expands beyond oncology.

China’s Biotech Rebound Fuels Cross-Border BD
Chinese biotech equities surged on renewed state support and market reforms, prompting global partners to revisit co-development and ex-China licensing. 👉 Read more

November Regulatory Watchlist Builds Momentum
FDA calendars remain packed with rare metabolic and renal-disease decisions, including plozasiran and sibeprenlimab, while ziftomenib (AML NPM1-mut) remains under priority review. 👉 Read more

Context: These outcomes could shape payer language for next-gen RNAi and antibody therapies heading into 2026.

AI Tackles Hospital VTE Prevention
Vanderbilt University Medical Center deployed an AI model to cut rates of venous thromboembolism, the leading cause of preventable hospital deaths, embedding risk prediction directly into workflow. 👉 Read more

Sanara MedTech to Refocus on Surgical Business
Sanara MedTech will divest non-core assets and concentrate on its surgical-focused wound-care portfolio, aligning capital allocation with higher-margin lines. 👉 Read more

Olympus Partners With COPD Foundation
The collaboration enhances patient education for severe emphysema and underscores Olympus’ expansion in interventional pulmonology. 👉 Read more

Alcon Earnings Scheduled for Release Today
Alcon (NYSE: ALC) is set to report Q3 2025 results later today, with investors focused on surgical-equipment momentum and ocular-health demand trends.👉 Read more

ValGenesis Named Biotechnology Innovator of the Year
Recognition for AI-enabled digital validation and lifecycle management solutions highlights growing digital-ops differentiation in regulated manufacturing. 👉 Read more

Sector Financing Reaches $26.6 B YTD
Bioworld MedTech reports 2025 financings at $26.6 billion, already topping 2023 levels, reflecting reopening IPO and private-placement windows. 👉 Read more

EY 2025 MedTech Report Shows Resilient Growth
EY’s Pulse of MedTech finds seven consecutive years of revenue growth, 16 % VC uptick, and larger M&A sizes, confirming capital-market normalization. 👉 Read more

Consumables Pulse — Wound Care and Home Health
The global medical-tape market is projected to reach $3.7 B by 2031 (3.8 % CAGR), a proxy for procedure volume and home-care utilization. 👉 Read more

Rhythm Pharma FDA Review Extended to March 2026
Setmelanotide for acquired hypothalamic obesity faces a longer review as FDA requests additional analyses; the delay comes amid obesity-pricing turbulence. 👉 Read more

Platform M&A Momentum Persists
Large-cap appetite for RNA, gene-editing, and neuromuscular assets remains robust following October’s Novartis–Avidity Biosciences acquisition.👉 Read more

Regulatory Center Gravity Shift at FDA
Pazdur’s appointment signals oncology-level data discipline and faster review structures moving across divisions.

Medtech Capital Flows Normalize
Financing volume and deal size growth confirm renewed investor confidence and larger-scale consolidation readiness.

China’s Biotech Recovery Re-anchors Valuations
Rising liquidity supports deeper co-development talks and cross-listing feasibility.

Digital Ops As A Differentiator
Validation and quality automation are emerging as critical levers for manufacturing scalability and audit resilience.

Alcon Q3 Earnings (Pre-Market, Nov 12)
Analysts anticipate surgical-equipment commentary and FY guidance updates.

CDER Transition Stakeholder Reactions
Industry statements and policy memos expected within 48 hours of Pazdur’s appointment.

Medtech Deal Follow-Through
Monitor OEM and service-platform M&A extensions after Olympus’ patient-engagement partnership.