Positron emission tomography

XyloCor Therapeutics Positive EXACT Phase 2 Data for Lead Candidate XC001 Simultaneously Presented at Society for Cardiovascular Angiography & Interventions (SCAI) 2024 Scientific Sessions and Published in Circulation: Cardiovascular Interventions

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星期四, 五月 2, 2024
Research, Genetics, Clinical Trials, Cardiology, Biotechnology, Health, Pharmaceutical, Other Science, Science, Society, University, Phase, Blood, Positron emission tomography, Circulation: Cardiovascular Interventions, Angina, Heart, PET, Disease, Exercise, Gene, Cardiovascular disease, Assistant, Clinical trial, Therapy, SCAI, VEGF, Prevalence, Pharmaceutical industry

XyloCor Therapeutics, Inc., a clinical‑stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today presented final results from the Phase 2 portion of its Phase 1/2 clinical trial (EXACT) of its lead gene therapy candidate XC001 (encoberminogene rezmadenovec) for refractory angina at the Society for Cardiovascular Angiography & Interventions (SCAI) 2024 Scientific Sessions, May 2-4, 2024 in Long Beach, CA.

Key Points: 
  • XyloCor Therapeutics, Inc., a clinical‑stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today presented final results from the Phase 2 portion of its Phase 1/2 clinical trial (EXACT) of its lead gene therapy candidate XC001 (encoberminogene rezmadenovec) for refractory angina at the Society for Cardiovascular Angiography & Interventions (SCAI) 2024 Scientific Sessions, May 2-4, 2024 in Long Beach, CA.
  • These encouraging results supporting XC001’s safety and efficacy potential are being simultaneously published in Circulation: Cardiovascular Interventions .
  • XC001 is designed to reduce ischemic burden by creating new blood vessels in the heart through the local expression of multiple vascular endothelial growth factor (VEGF) isoforms.
  • In the Phase 2 portion of the EXACT trial, 32 patients with class II-IV angina were dosed with the maximal dose of XC001 through minimally-invasive transepicardial delivery (direct administration to the heart).

EQS-News: Heidelberg Pharma announces receipt of non-refundable upfront cash payment following the successful closing of its royalty purchase agreement with HealthCare Royalty

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星期三, 四月 10, 2024
Diagnosis, Telix, Biologics license application, PET, Research, Sale, Multiple myeloma, Spacecraft, HPHA, ADC, USD, Positron emission tomography, Pharmaceutical industry

Ladenburg, Germany, 19 March 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), today announced the formal closing of the royalty purchase agreement with HealthCare Royalty (HCRx) for Zircaix®, signed earlier this month.

Key Points: 
  • Ladenburg, Germany, 19 March 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), today announced the formal closing of the royalty purchase agreement with HealthCare Royalty (HCRx) for Zircaix®, signed earlier this month.
  • Dr. George Badescu, Chief Business Officer at Heidelberg Pharma, said: “The funding from the royalty purchase agreement with HealthCare Royalty is enabling us to further advance Heidelberg Pharma’s leading expertise in the field of ADC research and development.
  • The upfront payment strengthens the Company’s liquidity, and along with future anticipated payments, should extend our cash runway.
  • The funds will be used to advance the expansion of our ADC pipeline including our preclinical projects HDP-102, HDP-103 and HDP-201.”

RLS Radiopharmacies Partners with Eckert & Ziegler to Expand Production of Gallium-68-Based Radiopharmaceuticals

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星期四, 四月 4, 2024
Oncology, Medical Devices, Health, Radiology, Pharmaceutical, Biotechnology, Gallium, Diagnosis, Radionuclide, Glomus tumor, Prostate cancer, USP, Half-life, Actinium-225, Partnership, Patient, Pharmacy, RLS, PET, Splenic infarction, Cancer, SDAX, Radiopharmaceutical, Investment, Cyclotron, ISO, Positron emission tomography, DSM-IV codes, Gelastic seizure, Medical imaging

Under the partnership, all 31 of RLS’s radiopharmacies will be equipped with Eckert & Ziegler’s advanced GalliaPharm® generators, which the radiopharmacy network will utilize to produce high-quality, life-enhancing Gallium-68-based (Ga-68) radiopharmaceuticals.

Key Points: 
  • Under the partnership, all 31 of RLS’s radiopharmacies will be equipped with Eckert & Ziegler’s advanced GalliaPharm® generators, which the radiopharmacy network will utilize to produce high-quality, life-enhancing Gallium-68-based (Ga-68) radiopharmaceuticals.
  • “A powerful diagnostic isotope, Gallium has an extremely short half-life, necessitating the need for Ga-68-based radiopharmaceuticals to be produced within minutes of patient dosing.
  • This signifies a major leap forward in our commitment to advancing healthcare and improving patient outcomes through cutting-edge radiopharmaceuticals."
  • To date, RLS has installed Eckert & Ziegler’s GalliaPharm® generators within most of its locations and anticipates the remaining radiopharmacies will be operational by the end of June.

EQS-News: Heidelberg Pharma Announces Royalty Financing Agreement with HealthCare Royalty for up to USD 115 million

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星期三, 三月 13, 2024
Morgan Stanley, Annual report, FDA, Food, Spacecraft, Sale, BLA, ADC, Telix, CAIX, McDermott Will & Emery, Patient, Diagnosis, HPHA, Phase, PET, Positron emission tomography, Pharmaceutical industry

Ladenburg, Germany, 4 March 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech Company developing innovative Antibody Drug Conjugates (ADCs), and HealthCare Royalty (HCRx) today announced that they have signed a royalty financing agreement.

Key Points: 
  • Ladenburg, Germany, 4 March 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech Company developing innovative Antibody Drug Conjugates (ADCs), and HealthCare Royalty (HCRx) today announced that they have signed a royalty financing agreement.
  • Key terms of the agreement between Heidelberg Pharma and HCRx:
    Following the receipt by HCRx of a maximum cumulative amount, royalty payments will revert to Heidelberg Pharma and HCRx will receive a low single digit royalty tail percentage thereafter
    Prof. Dr. Andreas Pahl, Chief Executive Officer at Heidelberg Pharma, commented: “We are delighted to partner with HealthCare Royalty.
  • This agreement will provide us with a non-dilutive financing based on expected royalty payments from the worldwide sales of ZircaixTM.
  • Heidelberg Pharma will hold a conference call on 25 March 2024 with the publication of the Annual Report.

Lantheus Announces Collaboration to Provide Novel Tau Imaging Agent for Large Consortium Clinical Trial Sponsored by the National Institute on Aging

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星期二, 二月 13, 2024
Research, Doctor of Philosophy, Dementia, MD, Public health, NIA, Medicine, LNTH, Non-fungible token, University, PET, Positron emission tomography, Medical imaging

BEDFORD, Mass., Feb. 13, 2024 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, today announced a collaboration agreement with a National Institute on Aging (NIA)-sponsored study called the Consortium for Clarity in ADRD Research Through Imaging (CLARiTI). This agreement enables the consortium to use MK-6240, Lantheus’ clinical-stage F18-labeled Positron Emission Tomography (PET) imaging agent, in its investigation of Alzheimer’s disease and related dementias. MK-6240 targets aggregated tau protein in the form of neurofibrillary tangles (NFTs) which are a hallmark of several neurodegenerative diseases, including Alzheimer’s disease.

Key Points: 
  • This agreement enables the consortium to use MK-6240, Lantheus’ clinical-stage F18-labeled Positron Emission Tomography (PET) imaging agent, in its investigation of Alzheimer’s disease and related dementias.
  • MK-6240 targets aggregated tau protein in the form of neurofibrillary tangles (NFTs) which are a hallmark of several neurodegenerative diseases, including Alzheimer’s disease.
  • “We are thrilled to partner with Lantheus to use MK-6240 for tau PET imaging in this important study.”
    “MK-6240 is poised to play a pivotal role in propelling Alzheimer’s diagnosis and treatment research to new heights,” said Jean-Claude Provost, MD, Chief Medical Officer, Lantheus.
  • “This agreement aligns with Lantheus’ purpose to actively cultivate collaborations that empower researchers worldwide with essential tools to accelerate clinical research and development of therapies.

Human medicines European public assessment report (EPAR): Vizamyl, flutemetamol (18F), Date of authorisation: 22/08/2014, Revision: 17, Status: Authorised

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星期二, 一月 2, 2024
Blood pressure, Amnesia, Patient, Medical Subject Headings, Autopsy, Marketing, European Commission, Dementia, Agency, INN, Risk, Physician, ATC, Positron emission tomography, International, European, PET, Nausea, Nuclear medicine, Brain, Language, Gelastic seizure, Cancer, Flushing, Chronic pain, Radiation, Lewy body dementias, Amyloid, Select, Committee, Medicine, Diagnosis, Safety, Radiopharmaceutical, Risk management, Anatomy, Skin, IIA, Deficit spending, CHMP, Medical imaging

Human medicines European public assessment report (EPAR): Vizamyl, flutemetamol (18F), Date of authorisation: 22/08/2014, Revision: 17, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Vizamyl, flutemetamol (18F), Date of authorisation: 22/08/2014, Revision: 17, Status: Authorised

Meilleur Technologies Inc. Announces Execution of Manufacturing Agreement with PharmaLogic for Production of the Next-Generation Amyloid PET Imaging Biomarker, NAV4694

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星期三, 十二月 20, 2023
Health, Neurology, Managed Care, Radiology, Pharmaceutical, Biotechnology, Disease, Positron emission tomography, PET, Brain, Alzheimer's disease, Neurodegenerative disease, Acceleration, MTI, Pharmaceutical industry

Meilleur Technologies Inc. (MTI) today announced it has signed an agreement with PharmaLogic Holdings Corporation (“PharmaLogic”) granting PharmaLogic the rights to manufacture fluorine-18 [F18]NAV4694, a next-generation investigational imaging biomarker used in Positron Emission Tomography (PET) imaging studies to assess the status of amyloid plaque in the brain.

Key Points: 
  • Meilleur Technologies Inc. (MTI) today announced it has signed an agreement with PharmaLogic Holdings Corporation (“PharmaLogic”) granting PharmaLogic the rights to manufacture fluorine-18 [F18]NAV4694, a next-generation investigational imaging biomarker used in Positron Emission Tomography (PET) imaging studies to assess the status of amyloid plaque in the brain.
  • Amyloid plaques are one of the pathological hallmarks of several neurodegenerative diseases, including Alzheimer’s Disease (AD).
  • Under the terms of its agreement, PharmaLogic will manufacture [F18]NAV4694 for use in clinical trials at select United States-based radiopharmacies.
  • “We are delighted that the NAV4694 clinical and research program will be supported by Pharmalogic's extensive PET manufacturing and dispensing expertise,” said Rick Hiatt, President and CEO of Meilleur Technologies, Inc. “Meilleur is focused on enabling acceleration of technologies that have the potential to advance the fight against debilitating neurodegenerative disease.

Meilleur Technologies Inc. Announces Use of the Next-Generation Amyloid PET Imaging Biomarker, NAV-4694, in the Young Blood Institute’s AmβARI study on Amyloid Removal

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星期二, 十二月 12, 2023
Health, Neurology, Clinical Trials, Research, Science, Biotechnology, University, Brain, Young blood transfusion, YBI, Plasma, Acceleration, Amyloid, Plasmapheresis, Dementia, MD, Trial of the century, F-18, Positron emission tomography, Diagnosis, Neurodegenerative disease, PET, Medical imaging

Amyloid plaques are a hallmark of several neurodegenerative diseases, including Alzheimer’s Disease (AD).

Key Points: 
  • Amyloid plaques are a hallmark of several neurodegenerative diseases, including Alzheimer’s Disease (AD).
  • The collaboration is focused on using [F-18]NAV-4694 as an imaging biomarker in the YBI AmβARI (Amyloid βeta Assessment & Removal Intervention) study.
  • The Young Blood Institute will utilize Meilleur’s [F-18]NAV-4694 tracer to aid YBI’s study of early detection and clearance of Amyloid βeta to prevent Alzheimer’s disease using Therapeutic Plasma Exchange.
  • Our goal is to expand the availability of this novel investigational imaging agent to the broader scientific community.”

Meilleur Technologies Inc. Announces Use of the Next-Generation Amyloid PET Imaging Biomarker, NAV-4694, in the Alzheimer’s Disease Neuroimaging Initiative 4 (ADNI4)

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星期五, 十月 20, 2023
Science, Neurology, Radiology, Biotechnology, Research, Health, Medical Devices, Genetics, AD, Positron emission tomography, Neurodegenerative disease, MD, Party, PET, ADNI, Brain, Diagnosis, Acceleration, Medical imaging

Meilleur Technologies, Inc. today announced a research collaboration agreement with the Alzheimer’s Disease Neuroimaging Initiative 4, ADNI4, on the use of Meilleur’s [F-18]NAV-4694, an investigational imaging agent, in Positron Emission Tomography (PET) scans to assess the status amyloid plaque in the brain.

Key Points: 
  • Meilleur Technologies, Inc. today announced a research collaboration agreement with the Alzheimer’s Disease Neuroimaging Initiative 4, ADNI4, on the use of Meilleur’s [F-18]NAV-4694, an investigational imaging agent, in Positron Emission Tomography (PET) scans to assess the status amyloid plaque in the brain.
  • Amyloid plaques are a hallmark of several neurodegenerative diseases, including Alzheimer’s Disease (AD).
  • The collaboration is focused on using [F-18]NAV-4694 as an imaging biomarker in ADNI4’s neurodegenerative disease research.
  • The Parties will apply [F-18]NAV-4694 imaging to aid ADNI4’s goal of a better understanding of AD to improve diagnosis and treatment of the devastating disease.

Tiziana Announces Positive Qualitative Six-Month PET Scan Results With Intranasal Foralumab Treating Multiple Sclerosis Patients Diagnosed With Non-Active Secondary Progressive MS (na-SPMS)

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星期五, 十月 13, 2023
ALS, Positron emission tomography, Nuclear medicine, Coronavirus Scientific Advisory Board, Mass, PET, Hospital, Disease, Expanded access, Patient, FDA, Special access program, Microglia, Neurology, Harvard Medical School, Assistant, Multiple sclerosis, DSM-IV codes, Microsoft Access, EAP, Medical imaging, Brigham

Activated microglia are believed to play a prominent role in the pathogenesis of neuroinflammatory and neurodegenerative diseases including multiple sclerosis, Alzheimer’s disease, and amyotrophic lateral sclerosis, or ALS.

Key Points: 
  • Activated microglia are believed to play a prominent role in the pathogenesis of neuroinflammatory and neurodegenerative diseases including multiple sclerosis, Alzheimer’s disease, and amyotrophic lateral sclerosis, or ALS.
  • When combined with my assessment of the first two Expanded Access patients at six-months, five of the six suggested a reduction in qualitative microglial PET signal.
  • An example of this can be seen in the graphic below, titled, “Figure 1”, showing the deactivation of this signal in patient EA6.
  • This is promising from an imaging standpoint, and further studies are needed to confirm these findings using additional quantitative approaches."