https://www.ovid.com/jnls/cnmo/fulltext/10.1097/nm9.0000000000000092~implementing-212-pb-targeted-alpha-therapy-a-safety-first If you had a ๐ง๐๐ฎ๐ซ๐จ๐๐ง๐๐จ๐๐ซ๐ข๐ง๐ ๐ญ๐ฎ๐ฆ๐จ๐ซ ๐ข๐ง ๐ฒ๐จ๐ฎ๐ซ ๐ฌ๐ญ๐จ๐ฆ๐๐๐ก, ๐ฌ๐ฆ๐๐ฅ๐ฅ ๐ข๐ง๐ญ๐๐ฌ๐ญ๐ข๐ง๐, ๐๐ฉ๐ฉ๐๐ง๐๐ข๐ฑ, ๐๐จ๐ฅ๐จ๐ง, ๐ฉ๐๐ง๐๐ซ๐๐๐ฌ, ๐ฅ๐ฎ๐ง๐ ๐ฌ, ๐๐๐ซ๐๐ง๐๐ฅ ๐ ๐ฅ๐๐ง๐๐ฌ, ๐ญ๐ก๐ฒ๐ซ๐จ๐ข๐, ๐ฉ๐ข๐ญ๐ฎ๐ข๐ญ๐๐ซ๐ฒ, ๐ซ๐๐๐ญ๐ฎ๐ฆ, ๐๐ซ๐๐๐ฌ๐ญ, ๐จ๐ซ ๐ฉ๐ซ๐จ๐ฌ๐ญ๐๐ญ๐, ๐ฐ๐จ๐ฎ๐ฅ๐ ๐ฒ๐จ๐ฎ ๐ฐ๐๐ง๐ญ ๐ญ๐จ ๐ญ๐ซ๐ฒ ๐ ๐ซ๐๐๐ข๐จ๐๐๐ญ๐ข๐ฏ๐ ๐๐ซ๐ฎ๐ ย as (a small) part of the treatment? The emerging clinical dataset highlights excellent short-term tolerability for 212Pb-TAT, with adverse events primarily consisting of low-grade […]
Archive for the ‘Pharma and Medical Device’ Category
If you had a neuroendocrine tumor, would you be willing to try a radioactive drug as a small part of your treatment?
Posted in Pharma and Medical Device, Regulatory Medical Writing 
Comments Off on If you had a neuroendocrine tumor, would you be willing to try a radioactive drug as a small part of your treatment?๐๐๐ซ๐ ๐๐ญ๐ข๐ง๐ ๐๐๐-๐๐ ๐ข๐ง ๐๐๐: Causal Driver, Toxic Passenger, or Loss-of-Function Crisis?
https://authors.elsevier.com/a/1nYxN4r9Rkz1wZ TDP-43 is the most common neuropathological signature of ALS and one of the two most common pathologies in frontotemporal dementia (FTD), alongside fused in sarcoma (FUS) proteinopathy.10,11 Its cytoplasmic mislocalization and aggregation are observed in approximately 97% of all ALS cases, both sporadic and familial, with the notable exceptions of SOD1-linked disease and FUS-associated […]
Posted in Neuroplasticity, Pharma and Medical Device, Regulatory Medical Writing Comments Off on ๐๐๐ซ๐ ๐๐ญ๐ข๐ง๐ ๐๐๐-๐๐ ๐ข๐ง ๐๐๐: Causal Driver, Toxic Passenger, or Loss-of-Function Crisis?Targeted Alpha Therapy as Cannonballs
The landscape of peptide receptor radionuclide therapy (PRRT) is shifting toward 212Pb, which has demonstrated ORRs in patients refractory to standard beta-emitters.1,2 First-in-human studies confirm the feasibility and tolerability of this approach, with disease stabilization observed even in heavily pretreated populations.3 The potent cytotoxicity of alpha particles results from dense ionization tracks, causing irreparable DNA […]
Posted in Pharma and Medical Device, Regulatory Medical Writing Comments Off on Targeted Alpha Therapy as Cannonballs๐๐ก๐ ๐๐๐ ๐๐ซ๐ฎ๐ ๐ ๐ซ๐๐ฏ๐๐ฒ๐๐ซ๐ ๐ข๐ฌ ๐๐ซ๐จ๐ฐ๐๐๐
Since 1995, when the FDA approved riluzole for amyotrophic lateral sclerosis (ALS) โ offering a median survival extension measured in weeks โ more than 60 compounds have advanced to clinical evaluation, with the overwhelming majority failing to demonstrate efficacy.(p1) It is worth distinguishing, within that graveyard, between uninformative โfailedโ trials that lacked biomarkers and left […]
Posted in Featured, Neuroplasticity, Pharma and Medical Device, Regulatory Medical Writing Comments Off on ๐๐ก๐ ๐๐๐ ๐๐ซ๐ฎ๐ ๐ ๐ซ๐๐ฏ๐๐ฒ๐๐ซ๐ ๐ข๐ฌ ๐๐ซ๐จ๐ฐ๐๐๐๐๐๐ซ๐ ๐๐ญ๐ข๐ง๐ ๐๐๐-๐๐ ๐ข๐ง ๐๐๐: ๐๐๐ ๐ฎ๐ฅ๐๐ญ๐จ๐ซ๐ฒ ๐ก๐ฎ๐ซ๐๐ฅ๐๐ฌ, ๐ญ๐ซ๐ข๐๐ฅ ๐๐๐ฌ๐ข๐ ๐ง ๐๐๐๐ข๐๐ข๐๐ง๐๐ข๐๐ฌ, ๐๐ง๐ ๐ญ๐ก๐ ๐๐๐ฎ๐ฌ๐๐ฅ ๐๐ฏ๐ข๐๐๐ง๐๐ ๐ ๐๐ฉ ๐๐จ๐ซ ๐๐๐ฑ๐๐๐๐
๐๐๐ซ๐ ๐๐ญ๐ข๐ง๐ ๐๐๐-๐๐ ๐ข๐ง ๐๐๐: ๐๐๐ ๐ฎ๐ฅ๐๐ญ๐จ๐ซ๐ฒ ๐ก๐ฎ๐ซ๐๐ฅ๐๐ฌ, ๐ญ๐ซ๐ข๐๐ฅ ๐๐๐ฌ๐ข๐ ๐ง ๐๐๐๐ข๐๐ข๐๐ง๐๐ข๐๐ฌ, ๐๐ง๐ ๐ญ๐ก๐ ๐๐๐ฎ๐ฌ๐๐ฅ ๐๐ฏ๐ข๐๐๐ง๐๐ ๐ ๐๐ฉ ๐๐จ๐ซ ๐๐๐ฑ๐๐๐๐, Michael A.S. Guth, Drug Discovery Today, Volume 31, Issue 5, 2026, 104752, ISSN 1359-6446, https://doi.org/10.1016/j.drudis.2026.104752. https://www.sciencedirect.com/science/article/pii/S1359644626001571 Highlights โข Over 60 amyotrophic lateral sclerosis (ALS) drug failures since 1995 underscore a persistent trial graveyard. โข CTX1000โs degron fusion selectively clears […]
Posted in Aging Adults, Pharma and Medical Device, Regulatory Medical Writing Comments Off on ๐๐๐ซ๐ ๐๐ญ๐ข๐ง๐ ๐๐๐-๐๐ ๐ข๐ง ๐๐๐: ๐๐๐ ๐ฎ๐ฅ๐๐ญ๐จ๐ซ๐ฒ ๐ก๐ฎ๐ซ๐๐ฅ๐๐ฌ, ๐ญ๐ซ๐ข๐๐ฅ ๐๐๐ฌ๐ข๐ ๐ง ๐๐๐๐ข๐๐ข๐๐ง๐๐ข๐๐ฌ, ๐๐ง๐ ๐ญ๐ก๐ ๐๐๐ฎ๐ฌ๐๐ฅ ๐๐ฏ๐ข๐๐๐ง๐๐ ๐ ๐๐ฉ ๐๐จ๐ซ ๐๐๐ฑ๐๐๐๐A microscopic-scale missile system designed to hunt down and destroy rogue cancer cells
Imagine a microscopic-scale missile system designed to hunt down and destroy rogue cancer cells one by one, while leaving healthy tissue completely untouched. That is the revolutionary promise of targeted alpha therapy, a cutting-edge field of medicine using specialized radioactive particles. By attaching these powerful alpha emitters to targeting molecules, doctors can deliver localized radiation […]
Posted in Pharma and Medical Device, Regulatory Medical Writing Comments Off on A microscopic-scale missile system designed to hunt down and destroy rogue cancer cellsSuccessful integration of Lead-212-targeted alpha therapy into routine clinical practice
Targeted alpha therapy (TAT) represents a transformative shift in precision oncology, offering high linear energy transfer over extremely short cellular paths to eradicate treatment-resistant malignancies. However, translating these powerful radioisotopes from the bench to the bedside introduces complex operational and toxicological bottlenecks. Chief among these is the management of transient daughter radionuclides like Lead-212 and […]
Posted in Pharma and Medical Device, Regulatory Medical Writing Comments Off on Successful integration of Lead-212-targeted alpha therapy into routine clinical practice“๐๐ก๐ ๐ช๐ฎ๐๐ฌ๐ญ๐ข๐จ๐ง ๐ข๐ฌ ๐ง๐จ๐ญ ๐ฐ๐ก๐๐ญ ๐ฒ๐จ๐ฎ ๐ฅ๐จ๐จ๐ค ๐๐ญ, ๐๐ฎ๐ญ ๐ฐ๐ก๐๐ญ ๐ฒ๐จ๐ฎ ๐ฌ๐๐.” โ ๐๐๐ง๐ซ๐ฒ ๐๐๐ฏ๐ข๐ ๐๐ก๐จ๐ซ๐๐๐ฎ
“๐๐ก๐ ๐ช๐ฎ๐๐ฌ๐ญ๐ข๐จ๐ง ๐ข๐ฌ ๐ง๐จ๐ญ ๐ฐ๐ก๐๐ญ ๐ฒ๐จ๐ฎ ๐ฅ๐จ๐จ๐ค ๐๐ญ, ๐๐ฎ๐ญ ๐ฐ๐ก๐๐ญ ๐ฒ๐จ๐ฎ ๐ฌ๐๐.” โ ๐๐๐ง๐ซ๐ฒ ๐๐๐ฏ๐ข๐ ๐๐ก๐จ๐ซ๐๐๐ฎ For decades, Alzheimer’s research has looked at the same data: amyloid plaques, tau tangles, neuroinflammation. But what if we have been seeing it wrong? Two underappreciated forcesโchronic stress and an oral bacterium called P. gingivalisโmay be converging on the […]
Posted in Aging Adults, Neuroplasticity, Pharma and Medical Device Comments Off on “๐๐ก๐ ๐ช๐ฎ๐๐ฌ๐ญ๐ข๐จ๐ง ๐ข๐ฌ ๐ง๐จ๐ญ ๐ฐ๐ก๐๐ญ ๐ฒ๐จ๐ฎ ๐ฅ๐จ๐จ๐ค ๐๐ญ, ๐๐ฎ๐ญ ๐ฐ๐ก๐๐ญ ๐ฒ๐จ๐ฎ ๐ฌ๐๐.” โ ๐๐๐ง๐ซ๐ฒ ๐๐๐ฏ๐ข๐ ๐๐ก๐จ๐ซ๐๐๐ฎ๐๐ก๐ ๐ข๐ง๐ญ๐ซ๐๐๐๐ฅ๐ฅ๐ฎ๐ฅ๐๐ซ ๐ฅ๐จ๐๐ค๐๐จ๐ฑ: ๐ก๐ฒ๐ฉ๐๐ซ๐ฉ๐ก๐จ๐ฌ๐ฉ๐ก๐จ๐ซ๐ฒ๐ฅ๐๐ญ๐๐ ๐ญ๐๐ฎ: ๐จ๐ง๐ ๐๐ฌ๐ฉ๐๐๐ญ ๐จ๐ ๐ญ๐ก๐ ๐๐ฎ๐๐ฅ ๐๐๐ช๐ฎ๐๐ฌ๐ญ๐ซ๐๐ญ๐ข๐จ๐ง ๐๐ฒ๐ฉ๐จ๐ญ๐ก๐๐ฌ๐ข๐ฌ ๐๐ฒ ๐๐ข๐๐ก๐๐๐ฅ ๐. ๐. ๐๐ฎ๐ญ๐ก
While Aฮฒ patrols the extracellular space, the microtubule-associated protein tau functions within neurons. In its normal state, tau stabilizes micro-tubules, which are crucial for axonal transport and structural integrity. Its pathological transformation into hyperphosphorylated, aggregated NFTs is another diagnostic hallmark of AD and strongly correlates with cognitive decline (Jellinger, 2020). The DSH suggests viewing pathological […]
Posted in Aging Adults, Neuroplasticity, Pharma and Medical Device, Regulatory Medical Writing Comments Off on ๐๐ก๐ ๐ข๐ง๐ญ๐ซ๐๐๐๐ฅ๐ฅ๐ฎ๐ฅ๐๐ซ ๐ฅ๐จ๐๐ค๐๐จ๐ฑ: ๐ก๐ฒ๐ฉ๐๐ซ๐ฉ๐ก๐จ๐ฌ๐ฉ๐ก๐จ๐ซ๐ฒ๐ฅ๐๐ญ๐๐ ๐ญ๐๐ฎ: ๐จ๐ง๐ ๐๐ฌ๐ฉ๐๐๐ญ ๐จ๐ ๐ญ๐ก๐ ๐๐ฎ๐๐ฅ ๐๐๐ช๐ฎ๐๐ฌ๐ญ๐ซ๐๐ญ๐ข๐จ๐ง ๐๐ฒ๐ฉ๐จ๐ญ๐ก๐๐ฌ๐ข๐ฌ ๐๐ฒ ๐๐ข๐๐ก๐๐๐ฅ ๐. ๐. ๐๐ฎ๐ญ๐กHas the definition of “positive neuroplasticity”ย and “negative neuroplasticity” evolved over time?
Has the definition of “positive neuroplasticity”ย and “negative neuroplasticity” evolved over time? This publication,ย Vance DE, Roberson AJ, McGuinness TM, Fazeli PL. Howย neuroplasticity and cognitive reserve protect cognitive functioning. Jย Psychosoc Nurs Ment Health Serv. 2010 Apr;48(4):23-30. doi:ย 10.3928/02793695-20100302-01. PMID: 20349891,ย defined โPositive neuroplasticity refers to he physiologicalย ability of the brain to form and strengthen dendritic connections, produceย beneficial morphological changes, […]
Posted in Neuroplasticity, Pharma and Medical Device, Regulatory Medical Writing Comments Off on Has the definition of “positive neuroplasticity”ย and “negative neuroplasticity” evolved over time?