Our radiopharmaceuticals in the middle of the street fark.com/go/11983038/www.…
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📅︎ Dec 14 2021
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S. 2609: A bill to amend title XVIII of the Social Security Act to ensure equitable payment for, and preserve Medicare beneficiary access to, diagnostic radiopharmaceuticals under the Medicare hospital outpatient prospective payment system.

Introduced: Sponsor: Sen. Marsha Blackburn [R-TN]

This bill was referred to the Senate Committee on Finance which will consider it before sending it to the Senate floor for consideration.

Govtrack.us Summary

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📅︎ Aug 05 2021
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QSAM Biosciences Announces FDA Clearance of IND for Samarium-153 DOTMP (CycloSam®), an Investigational Radiopharmaceutical for the Treatment of Bone Cancer

Austin, TX; August 25, 2021 – QSAM Biosciences Inc. (OTCQB: QSAM), a company developing next generation nuclear medicines, including Samarium-153 DOTMP (CycloSam®), for the treatment of cancer and related diseases and conditions, announced that the U.S. Food and Drug Administration (FDA) has cleared QSAM’s investigational new drug (IND) application which allows the Company to commence Phase 1 clinical trials and the dosing of patients with bone cancer.

“This IND clearance is another major milestone for QSAM and the advancement of CycloSam. We expect to commence our Phase 1 open-label dose escalation trial in bone cancer patients by the end of this year. These trials will be intended to investigate the efficacy, safety, tolerability and pharmacokinectics of CycloSam to establish the optimal dose for pivotal Phase 2/3 clinical trials,” stated the Company’s Co-Founder and CEO, Douglas R. Baum. “The clearance of our IND also continues to validate our data-driven approach in oncology drug development and sets the stage for additional aggressive efforts we are undertaking in pediatric and adult cancer therapies.”

CycloSam is expected to be a significantly improved formulation of a previously FDA-approved radiopharmaceutical. This novel drug candidate utilizes both a more efficient method of isotope manufacturing and an advanced chelation technology which may potentially allow for repeated dosing of patients with bone cancer in an effort to halt or reverse tumor growth.

About QSAM Biosciences: QSAM Biosciences, Inc. is developing next-generation nuclear medicines for the treatment of cancer and related diseases. QSAM’s initial technology is CycloSam® (Samarium-153 DOTMP), a clinical-stage bone targeting radiopharmaceutical developed by IsoTherapeutics Group LLC, pioneers in the nuclear medicine space who also developed a previous FDA-approved and commercially available radiopharmaceutical product indicated for pain palliation. QSAM is led by an experienced executive team and Board of Directors that have completed dozens of FDA approvals and multiple successful biotech exits. CycloSam® has demonstrated preliminary safety and efficacy in animal studies and a single patient FDA-cleared human trial successfully performed in 2020. This nuclear technology uses low specific activity Samarium-153 (resulting in far less europium-154 impurity) and DOTMP, a chelator which is believed to eliminate off-target migration and targets sites of high bone turn over makin

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📅︎ Aug 25 2021
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Fusion Pharmaceuticals Cleared by FDA to Begin Radiopharmaceutical Phase I Study precisiononcologynews.com…
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📅︎ Aug 11 2021
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$QSAM Biosciences Receives Favorable Safety Results in Study for its Leading Radiopharmaceutical Drug Candidate

https://www.otcmarkets.com/stock/QSAM/news/QSAM-Biosciences-Receives-Favorable-Safety-Results-in-Study-for-its-Leading-Radiopharmaceutical-Drug-Candidate?id=287026

Biosciences Receives Favorable Safety Results in Study for its Leading Radiopharmaceutical Drug Candidate

Palm Beach, FL, Jan. 21, 2021 (GLOBE NEWSWIRE) -- QSAM Biosciences Inc. (OTCQB: QSAM), a company developing next generation nuclear medicines for the treatment of cancer and related diseases and conditions, announced today favorable results from a study to evaluate the radioactive impurity levels in its flagship drug candidate Samarium-153-DOTMP (aka CycloSam®). The results of this study are positive indicators about the safety profile and potential expanded uses of CycloSam if ultimately approved for commercial usage by the U.S. Food and Drug Administration (FDA).

The study, conducted by leading radiopharmaceutical research firm, IsoTherapeutics Group, LLC, confirmed that the long-lived radionuclidic impurities of Europium-154 (Eu-154) in CycloSam are decreased over 40-fold to nearly non-detectable levels from those reported for a similar radiopharmaceutical product previously approved by the FDA for commercial usage. The findings also indicate significantly less buildup of these impurities, which enhances the clinical utility of CycloSam, potentially allowing safe, multiple dosing regimens, and possibly leading to broader therapeutic applications across multiple indications.

“We are very pleased with the results of this study as it confirms CycloSam’s superior safety profile for impurities and the integrity of our manufacturing procedures. Developing a radiopharmaceutical for the treatment of multiple types of primary and metastatic bone cancers that safely enables higher and multiple dosing significantly widens the therapeutic applications and utility of our product,” stated Douglas R. Baum, CEO and Co-Founder of QSAM.

QSAM expects to enter Phase 1 clinical trials for CycloSam in the first half of this year. The company, through its exclusive, worldwide license agreement with IsoTherapeutics Group, has issued patents that encompasses Sm-153 and reduced Euro

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👤︎ u/louied91
📅︎ Jan 21 2021
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A novel radiopharmaceutical for PET imaging of inflammation has been found to be well tolerated and safe according to preliminary trial results. The purpose of the 68Ga-labelled Siglec-9 peptide is to advance both the diagnostics of inflammatory diseases and drug development with molecular imaging. jnm.snmjournals.org/conte…
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📅︎ Apr 16 2021
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What is the future of nuclear medicine / radiopharmaceutical research like?

As more and more (traditional?) nuclear reactors are being shut down around the world, will the nuclear medicine field be negativy affected? Or is there a trend where nuclear reactors are repurposed for research purposes (including medical research), which may positively affect the field?

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📅︎ Jun 27 2020
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Radiopharmaceuticals

Hi everyone!

I’m looking to go into a masters in organic chemistry researching radiopharmaceuticals. I was wondering if anybody had any ideas for possible research topics, or what hot topics there currently are in radiopharmaceuticals (maybe focusing on their synthesis?).

Any help would be much appreciated, thank you!

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👤︎ u/ENISAS
📅︎ Oct 29 2020
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State health officials argue in court they want U.S. Radiopharmaceuticals to be penalized for not finishing cleanup (of radioactive waste still in Denton ) dentonrc.com/news/state-h…
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📅︎ Oct 09 2019
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ASRT Opposes NRC Proposed Changes to Radiopharmaceutical Training and Experience Standards asrt.org/main/news-public…
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📅︎ Jul 03 2019
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Does anyone have access to the journal “Cancer Biotherapy & Radiopharmaceuticals”?

I’m trying to get a copy of an obscure article that I absolutely need for my thesis, but my university and it’s network of affiliated libraries don’t subscribe to the journal it’s in. The authors also haven’t answered my emails... do any of you have access/could share a PDF of it?

Here is the link.

Thanks so much in advance to anyone that can help me out!

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📅︎ Mar 19 2020
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Cleanup work at U.S. Radiopharmaceuticals stopped dentonrc.com/news/cleanup…
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📅︎ May 21 2019
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What does the future of nuclear medicine / radiopharmaceuticals look like?

As more and more (traditional?) nuclear reactors are being shut down around the world, will the nuclear medicine field be negativy affected? Or is there a trend where nuclear reactors are repurposed for research purposes (including medical research), which may positively affect the field?

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📅︎ Jun 27 2020
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