Archive for the ‘Pharma and Medical Device’ Category

Alzheimer’s Dual Sequestration Hypothesis

Posted by Michael A. S. Guth on June 25th, 2026

๐๐ž๐ฐ ๐๐ฎ๐›๐ฅ๐ข๐œ๐š๐ญ๐ข๐จ๐ง ๐ข๐ง ๐…๐ซ๐ž๐ž ๐๐ž๐ฎ๐ซ๐จ๐ฉ๐š๐ญ๐ก๐จ๐ฅ๐จ๐ ๐ฒ (๐‰๐ฎ๐ง๐ž ๐Ÿ๐ŸŽ๐Ÿ๐Ÿ”) ๐ˆ ๐š๐ฆ ๐ฉ๐ฅ๐ž๐š๐ฌ๐ž๐ ๐ญ๐จ ๐ฌ๐ก๐š๐ซ๐ž ๐จ๐ฎ๐ซ ๐ฅ๐š๐ญ๐ž๐ฌ๐ญ ๐œ๐ฅ๐ข๐ง๐ข๐œ๐จ๐ฉ๐š๐ญ๐ก๐จ๐ฅ๐จ๐ ๐ข๐œ๐š๐ฅ ๐ฎ๐ฉ๐๐š๐ญ๐ž ๐š๐๐๐ซ๐ž๐ฌ๐ฌ๐ข๐ง๐  ๐š ๐ฉ๐ž๐ซ๐ฌ๐ข๐ฌ๐ญ๐ž๐ง๐ญ ๐ฉ๐š๐ซ๐š๐๐จ๐ฑ ๐ข๐ง ๐€๐ฅ๐ณ๐ก๐ž๐ข๐ฆ๐ž๐ซ’๐ฌ ๐๐ข๐ฌ๐ž๐š๐ฌ๐ž: ๐ฐ๐ก๐ฒ ๐ญ๐ก๐ž๐ซ๐š๐ฉ๐ข๐ž๐ฌ ๐ญ๐š๐ซ๐ ๐ž๐ญ๐ข๐ง๐  ๐ญ๐ก๐ž ๐ซ๐ž๐ฆ๐จ๐ฏ๐š๐ฅ ๐จ๐Ÿ ๐š๐ฆ๐ฒ๐ฅ๐จ๐ข๐-ฮฒ ๐ฉ๐ฅ๐š๐ช๐ฎ๐ž๐ฌ ๐š๐ง๐ ๐ญ๐š๐ฎ ๐ญ๐š๐ง๐ ๐ฅ๐ž๐ฌ ๐œ๐จ๐ง๐ฌ๐ข๐ฌ๐ญ๐ž๐ง๐ญ๐ฅ๐ฒ ๐ฌ๐ก๐จ๐ฐ ๐š ๐œ๐ซ๐ข๐ญ๐ข๐œ๐š๐ฅ ๐๐ข๐ฌ๐ฌ๐จ๐œ๐ข๐š๐ญ๐ข๐จ๐ง ๐Ÿ๐ซ๐จ๐ฆ ๐œ๐จ๐ซ๐ž ๐œ๐ฅ๐ข๐ง๐ข๐œ๐š๐ฅ ๐ฉ๐š๐ญ๐ก๐จ๐ ๐ž๐ง๐ž๐ฌ๐ข๐ฌ. ๐ˆ๐ง “๐€๐ฅ๐ณ๐ก๐ž๐ข๐ฆ๐ž๐ซ’๐ฌ ๐๐ข๐ฌ๐ž๐š๐ฌ๐ž ๐ข๐ง ๐ญ๐ก๐ž ๐๐ฅ๐š๐ฌ๐ญ๐ข๐œ๐ž๐ง๐ž ๐ž๐ซ๐š: ๐š ๐œ๐ฅ๐ข๐ง๐ข๐œ๐จ๐ฉ๐š๐ญ๐ก๐จ๐ฅ๐จ๐ ๐ข๐œ๐š๐ฅ ๐ฎ๐ฉ๐๐š๐ญ๐ž ๐จ๐ง ๐ญ๐ก๐ž […]

Posted in About, Neuroplasticity, Pharma and Medical Device, Regulatory Medical Writing Comments Off on Alzheimer’s Dual Sequestration Hypothesis
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๐‚๐š๐ง ๐ญ๐ก๐ž ๐”๐’ ๐๐ž๐œ๐จ๐ฆ๐ž ๐š ๐“๐ก๐ข๐ซ๐ ๐–๐จ๐ซ๐ฅ๐ ๐‚๐จ๐ฎ๐ง๐ญ๐ซ๐ฒ? ๐“๐ก๐ž ๐ƒ๐ซ๐ข๐ฉ, ๐ƒ๐ซ๐ข๐ฉ, ๐ƒ๐ซ๐ข๐ฉ ๐จ๐Ÿ ๐ƒ๐ž๐œ๐ฅ๐ข๐ง๐ข๐ง๐  ๐‡๐ž๐š๐ฅ๐ญ๐ก๐œ๐š๐ซ๐ž ๐‚๐จ๐ฏ๐ž๐ซ๐š๐ ๐ž.

Posted by Michael A. S. Guth on June 11th, 2026

Health insurance coverage in the USA is declining, driven by the expiration of enhanced Affordable Care Act (ACA) subsidies and post-pandemic Medicaid unwinding. Millions are dropping out of the market due to unaffordable premiums, while those who retain plans face narrower networks, stricter coverage denials, and higher out-of-pocket costs. The decline in US health insurance […]

Posted in Pharma and Medical Device, Regulatory Medical Writing Comments Off on ๐‚๐š๐ง ๐ญ๐ก๐ž ๐”๐’ ๐๐ž๐œ๐จ๐ฆ๐ž ๐š ๐“๐ก๐ข๐ซ๐ ๐–๐จ๐ซ๐ฅ๐ ๐‚๐จ๐ฎ๐ง๐ญ๐ซ๐ฒ? ๐“๐ก๐ž ๐ƒ๐ซ๐ข๐ฉ, ๐ƒ๐ซ๐ข๐ฉ, ๐ƒ๐ซ๐ข๐ฉ ๐จ๐Ÿ ๐ƒ๐ž๐œ๐ฅ๐ข๐ง๐ข๐ง๐  ๐‡๐ž๐š๐ฅ๐ญ๐ก๐œ๐š๐ซ๐ž ๐‚๐จ๐ฏ๐ž๐ซ๐š๐ ๐ž.
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Demystifying Long-Horizon Survival Forecasting in Oncology HTAโ€”Perspective Manuscript

Posted by Michael A. S. Guth on June 9th, 2026

Dear Drs. xxxxxxxxxxxx and xxxxxxxxxxxxxxx, I write to inquire whether the Journal of Clinical Epidemiology would consider a Perspective manuscript entitled xxxxxxxxxxxxxxxxxxxxxxxx. The manuscript (~5,100 words, 37 references) addresses a problem that experienced clinical epidemiologists and HTA reviewers recognize but that the published literature has been reluctant to name directly: when Phase 3 trials produce […]

Posted in Pharma and Medical Device, Regulatory Medical Writing Comments Off on Demystifying Long-Horizon Survival Forecasting in Oncology HTAโ€”Perspective Manuscript
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Adeno-associated virus serotype 9 (AAV9): tool of gene therapy that crosses the BBB

Posted by Michael A. S. Guth on June 4th, 2026

Adeno-associated virus serotype 9 (AAV9) is highly valued in gene therapy because it can cross the blood-brain barrier. It is primarily used to treat monogenic neurological and neuromuscular disorders, most notably Spinal Muscular Atrophy (SMA). AAV9 vectors deliver functional genetic material to replace or suppress faulty genes. Approved treatments and advanced clinical trials using AAV9 […]

Posted in Pharma and Medical Device, Regulatory Medical Writing Comments Off on Adeno-associated virus serotype 9 (AAV9): tool of gene therapy that crosses the BBB
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The Future of PTSD Treatment: Beyond the Daily Pill

Posted by Michael A. S. Guth on April 5th, 2026

We are currently witnessing a “Neuroplasticity Revolution” that is redefining the landscape of mental health care. Traditional treatments have often focused on managing the symptoms of PTSD through daily medication, but the focus is now shifting toward remodeling the brain’s actual architecture. This approach aims to fix the “hardware” of the brain, rather than just […]

Posted in Neuroplasticity, Pharma and Medical Device Comments Off on The Future of PTSD Treatment: Beyond the Daily Pill
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In the 1950s, my physicist father met with Albert Einstein at the Institute for Advanced Study to discuss unified field theory.

Posted by Michael A. S. Guth on April 5th, 2026

In the 1950s, my physicist father, Eugene Guth, met with Albert Einstein at the Institute for Advanced Study to discuss unified field theory. Einstein, it turned out, was more interested in the philosophy of physics than the math, a topic equally of interest to my dad.ย  See https://michaelguth.com/family/HistoryofPhysicsbyEugeneGuth.htm Mathematics and philosophy of physics have relevance […]

Posted in About, Featured, Neuroplasticity, Pharma and Medical Device Comments Off on In the 1950s, my physicist father met with Albert Einstein at the Institute for Advanced Study to discuss unified field theory.
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The FDA approval of Kresladi (marnetegragene autotemcel) on March 26, 2026

Posted by Michael A. S. Guth on April 2nd, 2026

The FDA approval of Kresladi (marnetegragene autotemcel) on March 26, 2026, is indeed a watershed moment for Rocket Pharmaceuticals and the LAD-I community. However, your question regarding the cost per patient touches on the most complex challenge in modern medicine: the “one-and-done” curative price tag. While Rocket Pharmaceuticals has not yet publicly released the official […]

Posted in Pharma and Medical Device Comments Off on The FDA approval of Kresladi (marnetegragene autotemcel) on March 26, 2026
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A New Blueprint for Turning an Orphan Brain Receptor into a Blockbuster Drug Target

Posted by Michael A. S. Guth on March 30th, 2026

Forthcoming inย Drug Discovery Today: A New Blueprint for Turning an Orphan Brain Receptor into a Blockbuster Drug Target I am pleased to announce that my article, “Accelerating the Orphan GPCR Pipeline: GPR149 as a Case Study in Dual-Domain Target Validation,” has been accepted for publication inย Drug Discovery Today, a leading journal for pharmaceutical strategy and […]

Posted in Neuroplasticity, Pharma and Medical Device Comments Off on A New Blueprint for Turning an Orphan Brain Receptor into a Blockbuster Drug Target
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“Chemo Brain” and Diabetes Research

Posted by Michael A. S. Guth on February 10th, 2026

Is the Next Breakthrough in “Chemo Brain” Treatment Hiding in Diabetes Research? For cancer survivors, the battle often doesn’t end with remission. Chemotherapy-Induced Cognitive Impairment (CICI)โ€”widely known as “Chemo Brain”โ€”remains one of the most debilitating long-term side effects of treatment, affecting memory, executive function, and attention. While the clinical impact is well-documented, therapeutic options remain […]

Posted in Featured, Neuroplasticity, Pharma and Medical Device Comments Off on “Chemo Brain” and Diabetes Research
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๐–๐ก๐ฒ ๐ƒ๐๐€ ๐Ž๐ซ๐ข๐ ๐š๐ฆ๐ข ๐ข๐ฌ ๐ญ๐ก๐ž ๐’๐ž๐œ๐ซ๐ž๐ญ ๐ญ๐จ ๐š “๐’๐ข๐ฅ๐ž๐ง๐ญ” ๐•๐š๐œ๐œ๐ข๐ง๐ž ๐’๐œ๐š๐Ÿ๐Ÿ๐จ๐ฅ๐ ๐ˆ๐ง ๐ฏ๐š๐œ๐œ๐ข๐ง๐ž ๐๐ž๐ฌ๐ข๐ ๐ง,

Posted by Michael A. S. Guth on February 7th, 2026

๐–๐ก๐ฒ ๐ƒ๐๐€ ๐Ž๐ซ๐ข๐ ๐š๐ฆ๐ข ๐ข๐ฌ ๐ญ๐ก๐ž ๐’๐ž๐œ๐ซ๐ž๐ญ ๐ญ๐จ ๐š “๐’๐ข๐ฅ๐ž๐ง๐ญ” ๐•๐š๐œ๐œ๐ข๐ง๐ž ๐’๐œ๐š๐Ÿ๐Ÿ๐จ๐ฅ๐ ๐ˆ๐ง ๐ฏ๐š๐œ๐œ๐ข๐ง๐ž ๐๐ž๐ฌ๐ข๐ ๐ง, “๐จ๐Ÿ๐Ÿ-๐ญ๐š๐ซ๐ ๐ž๐ญ” ๐ซ๐ž๐ฌ๐ฉ๐จ๐ง๐ฌ๐ž๐ฌ ๐š๐ซ๐ž ๐š ๐ฉ๐ž๐ซ๐ฌ๐ข๐ฌ๐ญ๐ž๐ง๐ญ ๐ก๐ฎ๐ซ๐๐ฅ๐ž. ๐–๐ก๐ž๐ง ๐ฐ๐ž ๐ฎ๐ฌ๐ž ๐ฉ๐ซ๐จ๐ญ๐ž๐ข๐ง-๐›๐š๐ฌ๐ž๐ ๐ฉ๐š๐ซ๐ญ๐ข๐œ๐ฅ๐ž๐ฌ ๐ญ๐จ ๐๐ž๐ฅ๐ข๐ฏ๐ž๐ซ ๐š๐ง ๐š๐ง๐ญ๐ข๐ ๐ž๐ง, ๐ญ๐ก๐ž ๐ข๐ฆ๐ฆ๐ฎ๐ง๐ž ๐ฌ๐ฒ๐ฌ๐ญ๐ž๐ฆ ๐จ๐Ÿ๐ญ๐ž๐ง ๐ ๐ž๐ญ๐ฌ ๐๐ข๐ฌ๐ญ๐ซ๐š๐œ๐ญ๐ž๐ ๐š๐ง๐ ๐š๐ญ๐ญ๐š๐œ๐ค๐ฌ ๐ญ๐ก๐ž ๐๐ž๐ฅ๐ข๐ฏ๐ž๐ซ๐ฒ ๐ฏ๐ž๐ก๐ข๐œ๐ฅ๐ž ๐ข๐ญ๐ฌ๐ž๐ฅ๐Ÿ ๐ข๐ง๐ฌ๐ญ๐ž๐š๐ ๐จ๐Ÿ ๐ญ๐ก๐ž ๐ฏ๐ข๐ซ๐ฎ๐ฌ. ๐๐ž๐ฐ ๐ซ๐ž๐ฌ๐ž๐š๐ซ๐œ๐ก ๐Ÿ๐ซ๐จ๐ฆ ๐Œ๐ˆ๐“ ๐š๐ง๐ ๐’๐œ๐ซ๐ข๐ฉ๐ฉ๐ฌ ๐‘๐ž๐ฌ๐ž๐š๐ซ๐œ๐ก, ๐ฉ๐ฎ๐›๐ฅ๐ข๐ฌ๐ก๐ž๐ ๐ข๐ง ๐’๐œ๐ข๐ž๐ง๐œ๐ž, […]

Posted in Pharma and Medical Device, Regulatory Medical Writing Comments Off on ๐–๐ก๐ฒ ๐ƒ๐๐€ ๐Ž๐ซ๐ข๐ ๐š๐ฆ๐ข ๐ข๐ฌ ๐ญ๐ก๐ž ๐’๐ž๐œ๐ซ๐ž๐ญ ๐ญ๐จ ๐š “๐’๐ข๐ฅ๐ž๐ง๐ญ” ๐•๐š๐œ๐œ๐ข๐ง๐ž ๐’๐œ๐š๐Ÿ๐Ÿ๐จ๐ฅ๐ ๐ˆ๐ง ๐ฏ๐š๐œ๐œ๐ข๐ง๐ž ๐๐ž๐ฌ๐ข๐ ๐ง,
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