Archive for the ‘Pharma and Medical Device’ Category

The 2026 Transatlantic Market Access Pivot: An Architectural Framework

Market Access 2026: Transatlantic Pivot Toolkit A Strategic Resource for Founders & VCs Navigating the EU JSC & NHS Threshold Shifts Prepared by Michael A. S. Guth, Ph.D., J.D. | Strategic Systems Architect for High-Complexity Biologics, Drugs, and Device combinations Executive Summary The 2026 regulatory-access landscape has fundamentally shifted with two parallel developments: EU’s Joint […]

๐๐ž๐ฒ๐จ๐ง๐ ๐‚๐Ž๐•๐ˆ๐ƒ-๐Ÿ๐Ÿ—: ๐“๐ก๐ž ๐๐ž๐ฑ๐ญ ๐…๐ซ๐จ๐ง๐ญ๐ข๐ž๐ซ๐ฌ ๐Ÿ๐จ๐ซ ๐ฆ๐‘๐๐€ ๐š๐ง๐ ๐ƒ๐ž๐ฅ๐ข๐ฏ๐ž๐ซ๐ฒ ๐๐ฅ๐š๐ญ๐Ÿ๐จ๐ซ๐ฆ๐ฌ ๐ข๐ง ๐†๐ฅ๐จ๐›๐š๐ฅ ๐ˆ๐ฆ๐ฆ๐ฎ๐ง๐ข๐ณ๐š๐ญ๐ข๐จ๐ง

๐“๐ก๐ž ๐ซ๐š๐ฉ๐ข๐ ๐ฆ๐š๐ญ๐ฎ๐ซ๐š๐ญ๐ข๐จ๐ง ๐จ๐Ÿ ๐ฆ๐‘๐๐€-๐‹๐๐ ๐ญ๐ž๐œ๐ก๐ง๐จ๐ฅ๐จ๐ ๐ฒ ๐ข๐ฌ ๐œ๐š๐ญ๐š๐ฅ๐ฒ๐ณ๐ข๐ง๐  ๐š ๐ง๐ž๐ฐ ๐ž๐ซ๐š ๐ข๐ง ๐ฏ๐š๐œ๐œ๐ข๐ง๐จ๐ฅ๐จ๐ ๐ฒ, ๐ฆ๐จ๐ฏ๐ข๐ง๐  ๐๐ž๐œ๐ข๐ฌ๐ข๐ฏ๐ž๐ฅ๐ฒ ๐›๐ž๐ฒ๐จ๐ง๐ ๐ฉ๐š๐ง๐๐ž๐ฆ๐ข๐œ ๐ซ๐ž๐ฌ๐ฉ๐จ๐ง๐ฌ๐ž. ๐“๐ก๐ž ๐Ÿ๐ŸŽ๐Ÿ๐Ÿ” ๐จ๐ฎ๐ญ๐ฅ๐จ๐จ๐ค ๐ก๐ข๐ ๐ก๐ฅ๐ข๐ ๐ก๐ญ๐ฌ ๐ฌ๐ž๐ฏ๐ž๐ซ๐š๐ฅ ๐œ๐จ๐ง๐ฏ๐ž๐ซ๐ ๐ž๐ง๐ญ ๐ญ๐ซ๐š๐œ๐ค๐ฌ: ๐๐ฅ๐š๐ญ๐Ÿ๐จ๐ซ๐ฆ ๐„๐ฑ๐ฉ๐š๐ง๐ฌ๐ข๐จ๐ง: ๐“๐ก๐ž ๐œ๐จ๐ซ๐ž ๐ข๐ง๐ง๐จ๐ฏ๐š๐ญ๐ข๐จ๐งโ€”๐ฎ๐ฌ๐ข๐ง๐  ๐‹๐๐๐ฌ ๐ญ๐จ ๐๐ž๐ฅ๐ข๐ฏ๐ž๐ซ ๐‘๐๐€ ๐ฌ๐ž๐ช๐ฎ๐ž๐ง๐œ๐ž๐ฌ ๐ž๐ง๐œ๐จ๐๐ข๐ง๐  ๐ฉ๐ซ๐จ๐ญ๐ž๐ข๐ง ๐ข๐ฆ๐ฆ๐ฎ๐ง๐จ๐ ๐ž๐ง๐ฌโ€”๐ข๐ฌ ๐›๐ž๐ข๐ง๐  ๐๐ž๐ฉ๐ฅ๐จ๐ฒ๐ž๐ ๐š๐ ๐š๐ข๐ง๐ฌ๐ญ ๐ก๐ข๐ฌ๐ญ๐จ๐ซ๐ข๐œ๐š๐ฅ๐ฅ๐ฒ ๐ข๐ง๐ญ๐ซ๐š๐œ๐ญ๐š๐›๐ฅ๐ž ๐ฉ๐š๐ญ๐ก๐จ๐ ๐ž๐ง๐ฌ. ๐…๐จ๐ซ ๐‡๐ˆ๐•, ๐ ๐ž๐ซ๐ฆ๐ฅ๐ข๐ง๐ž-๐ญ๐š๐ซ๐ ๐ž๐ญ๐ข๐ง๐  ๐ฌ๐ญ๐ซ๐š๐ญ๐ž๐ ๐ข๐ž๐ฌ ๐ฐ๐ข๐ญ๐ก ๐ฌ๐ž๐ช๐ฎ๐ž๐ง๐ญ๐ข๐š๐ฅ ๐ฆ๐‘๐๐€ ๐›๐จ๐จ๐ฌ๐ญ๐ž๐ซ๐ฌ ๐š๐ข๐ฆ ๐ญ๐จ ๐ ๐ฎ๐ข๐๐ž […]

๐—”๐—ฅ๐—˜ ๐—ช๐—˜ ๐—ก๐—ข๐—ช ๐—œ๐—ก ๐—ง๐—›๐—˜ ๐—•๐—จ๐—ฆ๐—œ๐—ก๐—˜๐—ฆ๐—ฆ ๐—ข๐—™ ๐—ฅ๐—˜๐—œ๐— ๐—•๐—จ๐—ฅ๐—ฆ๐—œ๐—ก๐—š “๐—ก๐—ข๐—ก-๐—œ๐—ก๐—™๐—˜๐—ฅ๐—œ๐—ข๐—ฅ?”

๐—–๐—ต๐—ฎ๐—น๐—น๐—ฒ๐—ป๐—ด๐—ฒ ๐˜๐—ต๐—ฒ ๐—ฝ๐—ฟ๐—ฒ๐—บ๐—ถ๐˜€๐—ฒ ๐—ผ๐—ณ ๐—ฐ๐—ฒ๐—น๐—ฒ๐—ฏ๐—ฟ๐—ฎ๐˜๐—ถ๐—ป๐—ด ๐—ป๐—ผ๐—ป-๐—ถ๐—ป๐—ณ๐—ฒ๐—ฟ๐—ถ๐—ผ๐—ฟ๐—ถ๐˜๐˜† ๐—ถ๐—ป ๐—ฎ ๐—บ๐—ฎ๐˜๐˜‚๐—ฟ๐—ฒ ๐—บ๐—ฎ๐—ฟ๐—ธ๐—ฒ๐˜ ๐—ฎ๐—ป๐—ฑ ๐—พ๐˜‚๐—ฒ๐˜€๐˜๐—ถ๐—ผ๐—ป ๐˜๐—ต๐—ฒ ๐—ต๐—ฒ๐—ฎ๐—น๐˜๐—ต ๐—ฒ๐—ฐ๐—ผ๐—ป๐—ผ๐—บ๐—ถ๐—ฐ ๐—ฟ๐—ฎ๐˜๐—ถ๐—ผ๐—ป๐—ฎ๐—น๐—ฒ. ๐—›๐—ฒ๐—ฎ๐—ฑ๐—น๐—ถ๐—ป๐—ฒ: ๐—” ๐—ก๐—ฒ๐˜„ ๐—ฃ๐—ถ๐—น๐—น ๐—ณ๐—ผ๐—ฟ ๐—›๐—œ๐—ฉ: ๐—œ๐—ป๐—ฐ๐—ฟ๐—ฒ๐—บ๐—ฒ๐—ป๐˜๐—ฎ๐—น ๐—–๐—ต๐—ฎ๐—ป๐—ด๐—ฒ ๐—ผ๐—ฟ ๐—ฃ๐—ฟ๐—ถ๐—ฐ๐—ฒ๐—ฑ ๐—ฎ๐˜€ ๐—œ๐—ป๐—ป๐—ผ๐˜ƒ๐—ฎ๐˜๐—ถ๐—ผ๐—ป? ๐—š๐—ถ๐—น๐—ฒ๐—ฎ๐—ฑ’๐˜€ ๐—”๐—ฅ๐—ง๐—œ๐—ฆ๐—ง๐—ฅ๐—ฌ-๐Ÿฎ ๐˜๐—ฟ๐—ถ๐—ฎ๐—น ๐˜€๐—ต๐—ผ๐˜„๐˜€ ๐—ถ๐˜๐˜€ ๐—ป๐—ฒ๐˜„ ๐—•๐—œ๐—–/๐—Ÿ๐—˜๐—ก ๐˜€๐—ถ๐—ป๐—ด๐—น๐—ฒ-๐˜๐—ฎ๐—ฏ๐—น๐—ฒ๐˜ ๐—ฟ๐—ฒ๐—ด๐—ถ๐—บ๐—ฒ๐—ป ๐—ถ๐˜€ ๐—ป๐—ผ๐—ป-๐—ถ๐—ป๐—ณ๐—ฒ๐—ฟ๐—ถ๐—ผ๐—ฟ ๐˜๐—ผ ๐—ถ๐˜๐˜€ ๐—ผ๐˜„๐—ป ๐—ฏ๐—น๐—ผ๐—ฐ๐—ธ๐—ฏ๐˜‚๐˜€๐˜๐—ฒ๐—ฟ, ๐—•๐—œ๐—ž๐—ง๐—”๐—ฅ๐—ฉ๐—ฌ, ๐—ณ๐—ผ๐—ฟ ๐˜ƒ๐—ถ๐—ฟ๐—ผ๐—น๐—ผ๐—ด๐—ถ๐—ฐ๐—ฎ๐—น๐—น๐˜† ๐˜€๐˜‚๐—ฝ๐—ฝ๐—ฟ๐—ฒ๐˜€๐˜€๐—ฒ๐—ฑ ๐—ฝ๐—ฎ๐˜๐—ถ๐—ฒ๐—ป๐˜๐˜€. ๐—ง๐—ต๐—ฒ ๐˜€๐—ฐ๐—ถ๐—ฒ๐—ป๐—ฐ๐—ฒ ๐—ถ๐˜€ ๐˜€๐—ผ๐˜‚๐—ป๐—ฑ, ๐—ฏ๐˜‚๐˜ ๐—ถ๐˜ ๐—ฝ๐—ฟ๐—ผ๐—บ๐—ฝ๐˜๐˜€ […]

A New Anchor in RRMM: Decoding the Practice-Changing MajesTEC-3 Data for Tec-Dara

The MajesTEC-3 results for teclistamab + daratumumab (Tec-Dara)ย in relapsed/refractory multiple myeloma (RRMM) aren’t just an incremental gainโ€”they represent a potential paradigm shift. The FDA’s concurrent award of aย priority review voucherย underscores its transformative potential. Let’s break down the data that’s changing the standard of care: ๐Ÿ”ฌ Unprecedented Efficacy in the 1-3 Prior Lines Setting: โ€ขย PFS:ย Hazard Ratio […]

๐–๐ก๐ฒ “๐•๐ข๐ซ๐ญ๐ฎ๐š๐ฅ ๐’๐œ๐ซ๐ž๐ž๐ง๐ข๐ง๐ ” ๐ข๐ฌ ๐๐จ ๐‹๐จ๐ง๐ ๐ž๐ซ ๐„๐ง๐จ๐ฎ๐ ๐ก ๐Ÿ๐จ๐ซ ๐Ž๐ซ๐ฉ๐ก๐š๐ง ๐†๐๐‚๐‘๐ฌ

๐…๐จ๐ซ ๐ฒ๐ž๐š๐ซ๐ฌ, ๐ญ๐ก๐ž ๐ข๐ง๐๐ฎ๐ฌ๐ญ๐ซ๐ฒ ๐ซ๐ž๐ฅ๐ข๐ž๐ ๐จ๐ง ๐ญ๐ซ๐š๐๐ข๐ญ๐ข๐จ๐ง๐š๐ฅ ๐ฏ๐ข๐ซ๐ญ๐ฎ๐š๐ฅ ๐ฌ๐œ๐ซ๐ž๐ž๐ง๐ข๐ง๐  ๐ญ๐จ ๐Ÿ๐ข๐ง๐ ๐ง๐ž๐ž๐๐ฅ๐ž๐ฌ ๐ข๐ง ๐ญ๐ก๐ž “๐ƒ๐š๐ซ๐ค ๐†๐ž๐ง๐จ๐ฆ๐ž” ๐ก๐š๐ฒ๐ฌ๐ญ๐š๐œ๐ค. ๐๐ฎ๐ญ ๐Ÿ๐จ๐ซ ๐จ๐ซ๐ฉ๐ก๐š๐ง ๐ญ๐š๐ซ๐ ๐ž๐ญ๐ฌ ๐ฅ๐ข๐ค๐ž ๐†๐๐‘๐Ÿ๐Ÿ’๐Ÿ—, ๐ฐ๐ก๐ž๐ซ๐ž ๐ฅ๐ข๐ ๐š๐ง๐ ๐œ๐ก๐ž๐ฆ๐ข๐ฌ๐ญ๐ซ๐ฒ ๐ข๐ฌ ๐ฎ๐ง๐๐ž๐Ÿ๐ข๐ง๐ž๐, ๐ฐ๐ž ๐ง๐ž๐ž๐ ๐ฆ๐จ๐ซ๐ž ๐ญ๐ก๐š๐ง ๐š ๐›๐ž๐ญ๐ญ๐ž๐ซ ๐ฌ๐ž๐š๐ซ๐œ๐ก ๐ž๐ง๐ ๐ข๐ง๐ž. ๐–๐ž ๐ง๐ž๐ž๐ ๐š ๐†๐ž๐ง๐ž๐ซ๐š๐ญ๐ข๐ฏ๐ž ๐„๐ง๐ ๐ข๐ง๐ž. ๐€๐ฌ ๐ฉ๐š๐ซ๐ญ ๐จ๐Ÿ ๐ฆ๐ฒ ๐ฅ๐š๐ญ๐ž๐ฌ๐ญ “๐ˆ๐ง๐๐ฎ๐ฌ๐ญ๐ซ๐ข๐š๐ฅ ๐๐ฅ๐ฎ๐ž๐ฉ๐ซ๐ข๐ง๐ญ” ๐Ÿ๐จ๐ซ ๐ƒ๐ซ๐ฎ๐  ๐ƒ๐ข๐ฌ๐œ๐จ๐ฏ๐ž๐ซ๐ฒ ๐“๐จ๐๐š๐ฒ, ๐ˆโ€™๐ฏ๐ž ๐จ๐ฎ๐ญ๐ฅ๐ข๐ง๐ž๐ ๐ฐ๐ก๐ฒ […]

๐…๐ซ๐จ๐ฆ ๐€๐ฌ๐ฌ๐ข๐ฌ๐ญ๐š๐ง๐œ๐ž ๐ญ๐จ ๐€๐ ๐ž๐ง๐œ๐ฒ: ๐–๐ก๐ฒ ๐๐ซ๐ž๐œ๐ข๐ฌ๐ข๐จ๐ง ๐‚๐š๐ซ๐ž ๐†๐ข๐š๐ง๐ญ๐ฌ ๐๐ž๐ž๐ ๐‚๐จ๐ฆ๐›๐ข๐ง๐ž๐ ๐‘๐ž๐ ๐ฎ๐ฅ๐š๐ญ๐จ๐ซ๐ฒ/๐“๐ก๐ž๐ซ๐š๐ฉ๐ž๐ฎ๐ญ๐ข๐œ ๐€๐ซ๐ž๐š/๐€๐ˆ ๐’๐ค๐ข๐ฅ๐ฅ๐ž๐ ๐“๐š๐ฅ๐ž๐ง๐ญ

๐“๐ก๐ž “๐๐ฎ๐ซ๐ฉ๐ฅ๐ž ๐’๐ช๐ฎ๐ข๐ซ๐ซ๐ž๐ฅ” ๐“๐š๐ฅ๐ž๐ง๐ญ ๐†๐š๐ฉ Recruiters often call this the โ€œpurple squirrelโ€ profile: a “unicorn” blending deep regulatory strategy, therapeutic area such as neurology research expertise, with a fundamental understanding of AI application.

Beyond the 16-Week Snapshot: Why Data Snapshots Mask the Reality of Chronic Therapy

Beyond the 16-Week Snapshot: Why Data Snapshots Mask the Reality of Chronic Therapy In my independent review of the CARES-310 trial (Camrelizumab-Rivoceranib), I analyzed a common pitfall in modern drug development: the reliance on 16-week primary endpoints to justify long-term therapeutic narratives. While a 16-week data cut can deliver a clean p-value for a regulatory […]

Pharyngeal Electrical Stimulation (PES) for Neurogenic Dysphagia: An Overview

Pharyngeal Electrical Stimulation (PES) for Neurogenic Dysphagia: An Overview Introduction to Neurogenic Dysphagia and the Need for Restorative Therapy Neurogenic dysphagia (ND) is a swallowing impairment resulting from neurological damage, most commonly caused by stroke, multiple sclerosis (MS), traumatic brain injury, or neurodegenerative diseases.1 ND is associated with severe complications, including malnutrition, dehydration, and aspiration […]

๐“๐ก๐ž ๐„๐ง๐ ๐ข๐ง๐ž ๐๐ž๐ก๐ข๐ง๐ ๐ญ๐ก๐ž ๐Œ๐จ๐ฅ๐ž๐œ๐ฎ๐ฅ๐ž: ๐–๐ก๐ฒ ๐Œ๐š๐ฆ๐ฆ๐š๐ฅ๐ข๐š๐ง ๐‚๐ž๐ฅ๐ฅ ๐„๐ง๐ ๐ข๐ง๐ž๐ž๐ซ๐ข๐ง๐  ๐ข๐ฌ ๐‚๐ž๐ง๐ญ๐ซ๐š๐ฅ ๐ญ๐จ ๐Œ๐จ๐๐ž๐ซ๐ง ๐ƒ๐ซ๐ฎ๐  ๐ƒ๐ข๐ฌ๐œ๐จ๐ฏ๐ž๐ซ๐ฒ.

๐“๐ก๐ž ๐„๐ง๐ ๐ข๐ง๐ž ๐๐ž๐ก๐ข๐ง๐ ๐ญ๐ก๐ž ๐Œ๐จ๐ฅ๐ž๐œ๐ฎ๐ฅ๐ž: ๐–๐ก๐ฒ ๐Œ๐š๐ฆ๐ฆ๐š๐ฅ๐ข๐š๐ง ๐‚๐ž๐ฅ๐ฅ ๐„๐ง๐ ๐ข๐ง๐ž๐ž๐ซ๐ข๐ง๐  ๐ข๐ฌ ๐‚๐ž๐ง๐ญ๐ซ๐š๐ฅ ๐ญ๐จ ๐Œ๐จ๐๐ž๐ซ๐ง ๐ƒ๐ซ๐ฎ๐  ๐ƒ๐ข๐ฌ๐œ๐จ๐ฏ๐ž๐ซ๐ฒ. ๐ˆ๐ง ๐ญ๐ก๐ž ๐ซ๐š๐œ๐ž ๐ญ๐จ ๐๐ž๐ฏ๐ž๐ฅ๐จ๐ฉ ๐œ๐จ๐ฆ๐ฉ๐ฅ๐ž๐ฑ ๐ญ๐ก๐ž๐ซ๐š๐ฉ๐ž๐ฎ๐ญ๐ข๐œ๐ฌ, ๐ญ๐ก๐ž ๐ž๐ฑ๐ฉ๐ซ๐ž๐ฌ๐ฌ๐ข๐จ๐ง ๐ฌ๐ฒ๐ฌ๐ญ๐ž๐ฆ ๐ข๐ฌ ๐š ๐œ๐ซ๐ข๐ญ๐ข๐œ๐š๐ฅ ๐ฌ๐ญ๐ซ๐š๐ญ๐ž๐ ๐ข๐œ ๐œ๐ก๐จ๐ข๐œ๐ž. ๐…๐จ๐ซ ๐ฆ๐š๐ง๐ฒ ๐๐ซ๐ฎ๐  ๐œ๐š๐ง๐๐ข๐๐š๐ญ๐ž๐ฌโ€”๐ž๐ฌ๐ฉ๐ž๐œ๐ข๐š๐ฅ๐ฅ๐ฒ ๐š๐ง๐ญ๐ข๐›๐จ๐๐ข๐ž๐ฌ, ๐Ÿ๐ฎ๐ฌ๐ข๐จ๐ง ๐ฉ๐ซ๐จ๐ญ๐ž๐ข๐ง๐ฌ, ๐š๐ง๐ ๐œ๐จ๐ฆ๐ฉ๐ฅ๐ž๐ฑ ๐ž๐ง๐ณ๐ฒ๐ฆ๐ž๐ฌโ€”๐ฆ๐š๐ฆ๐ฆ๐š๐ฅ๐ข๐š๐ง ๐œ๐ž๐ฅ๐ฅ๐ฌ ๐š๐ซ๐ž ๐ง๐จ๐ง-๐ง๐ž๐ ๐จ๐ญ๐ข๐š๐›๐ฅ๐ž. ๐‡๐ž๐ซ๐žโ€™๐ฌ ๐ฐ๐ก๐ฒ ๐จ๐ฎ๐ซ ๐Ÿ๐จ๐œ๐ฎ๐ฌ ๐ก๐š๐ฌ ๐ข๐ง๐ญ๐ž๐ง๐ฌ๐ข๐Ÿ๐ข๐ž๐ ๐จ๐ง ๐ž๐ง๐ ๐ข๐ง๐ž๐ž๐ซ๐ข๐ง๐  ๐ญ๐ก๐ž ๐ฌ๐ฒ๐ฌ๐ญ๐ž๐ฆ ๐ข๐ญ๐ฌ๐ž๐ฅ๐Ÿ: ๐…๐ข๐๐ž๐ฅ๐ข๐ญ๐ฒ […]

COVID-19 Treatment Strategies: Dec 2025 update

Moving Simulation of SARS-CoV-2 Delta Variant

Image:ย  Computerย Simulation of SARS-CoV-2. Reprinted with kind permission of Janet Iwasa of http://animationlab.utah.edu/cova Should I Get a COVID-19 Vaccine in December 2025 or January 2026? As we move through the winter of 2025-2026, the question of whether to get a COVID-19 vaccine is highly relevant, especially as respiratory viruses typically peak during this time. The […]