Positron emission tomography

Evergreen Theragnostics Submits New Drug Application for Gallium-68 DOTATOC Kit with US FDA

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星期一, 十二月 12, 2022
PET, NDA, Doctor of Philosophy, Patient, Wilms' tumor, New Drug Application, GMP, Neoplasm, FDA, UI, Kit, University, Positron emission tomography, University of Iowa, Evergreen, PDUFA, MBA, Medical imaging, Pharmaceutical industry, CDMO, Radiology

SPRINGFIELD, N.J., Dec. 12, 2022 /PRNewswire/ -- Evergreen Theragnostics has submitted a New Drug Application (NDA) for EVG-001 (Kit for preparation of Gallium-68 DOTATOC Injection), a radiopharmaceutical for imaging of neuroendocrine tumors using Positron Emission Tomography (PET), tothe U.S. Food and Drug Administration (FDA).

Key Points: 
  • SPRINGFIELD, N.J., Dec. 12, 2022 /PRNewswire/ -- Evergreen Theragnostics has submitted a New Drug Application (NDA) for EVG-001 (Kit for preparation of Gallium-68 DOTATOC Injection), a radiopharmaceutical for imaging of neuroendocrine tumors using Positron Emission Tomography (PET), tothe U.S. Food and Drug Administration (FDA).
  • The FDA has accepted the application for review and granted a target approval date (PDUFA date) of July 20, 2023.
  • "Gallium-68 DOTATOC imaging has been clinically used in Europe for well over a decade," said James Cook, President & CEO of Evergreen Theragnostics.
  • "The University of Iowa took an important step in 2019 by gaining FDA approval for their own NDA for Gallium-68 DOTATOC, produced locally at the University of Iowa.

Eisai Presents Full Results of Lecanemab Phase 3 Confirmatory Clarity Ad Study for Early Alzheimer's Disease at Clinical Trials on Alzheimer's Disease (CTAD) Conference

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星期三, 十一月 30, 2022
Pathology, Hypertension, ADAS, PET, MCI, Positron emission tomography, Degenerative disease, Brain, ADCS, AD, Patient, Biogen, Biomarker, Apolipoprotein E, Diabetes, Confidence interval, Clarity, Alzheimer's disease, Kidney, Memantine, Cerebrospinal fluid, Trial of the century, CSF, Obesity, Medical imaging, Pharmaceutical industry, Eisai

Eisai's Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early AD (lecanemab group: 898 placebo group: 897) at 235 sites in North America, Europe, and Asia.

Key Points: 
  • Eisai's Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early AD (lecanemab group: 898 placebo group: 897) at 235 sites in North America, Europe, and Asia.
  • Eligibility criteria allowed patients with a broad range of comorbidities/comedications, including but not limited to hypertension, diabetes, heart disease, obesity, renal disease and anti-coagulants.
  • Lecanemab slowed decline of cognitive function by 26% on ADAS-Cog14 at 18 months (mean difference: -1.44 [95%CI: -2.27, -0.61]; P=0.00065).
  • In the ADCOMS assessment, lecanemab slowed disease progression by 24% at 18 months (mean difference: -0.050 [95% CI: -0.074, -0.027; P=0.00002]).

EISAI PRESENTS FULL RESULTS OF LECANEMAB PHASE 3 CONFIRMATORY CLARITY AD STUDY FOR EARLY ALZHEIMER'S DISEASE AT CLINICAL TRIALS ON ALZHEIMER'S DISEASE (CTAD) CONFERENCE

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星期三, 十一月 30, 2022
Pathology, Hypertension, ADAS, PET, MCI, Headquarters, Positron emission tomography, Corporation, Degenerative disease, Brain, ADCS, AD, Patient, Biogen, Biomarker, Apolipoprotein E, Diabetes, Confidence interval, BIIB, Clarity, Alzheimer's disease, Kidney, Memantine, Cerebrospinal fluid, Trial of the century, CSF, Obesity, Medical imaging, Pharmaceutical industry, Eisai

Eisai's Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early AD (lecanemab group: 898 placebo group: 897) at 235 sites in North America, Europe, and Asia.

Key Points: 
  • Eisai's Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early AD (lecanemab group: 898 placebo group: 897) at 235 sites in North America, Europe, and Asia.
  • In the ADCOMS assessment, lecanemab slowed disease progression by 24% at 18 months (mean difference: -0.050 [95% CI: -0.074, -0.027; P=0.00002]).
  • In Eisai's confirmatory Clarity AD study, lecanemab demonstrated consistency of results across scales of cognition and function and subgroups (race, ethnicity, comorbidities).
  • 2ADAS-Cog is the most common cognitive assessment instrument used in AD clinical trials all over the world.

Diffusion Pharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Business Update

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星期一, 十一月 14, 2022
COVID-19, Growth, Oxygen, Patient, Particular, Hypoxia, LLP, Temozolomide, Smith College commencement controversies, Magnetic resonance imaging, Pharmacokinetics, Positron emission tomography, Tissue, Safety, Neuro-Oncology (journal), Dechert, Tumor hypoxia, Progression-free survival, Annual report, Research, Disease, Standard of care, GBM, Security, Cancer, TSC, Survival, Clinician Administered PTSD Scale, FDA, Risk management, Medical imaging, Pharmaceutical industry, Diffusion

Ended Quarter with $25.9 million in Cash, Cash Equivalents and Marketable Securities

Key Points: 
  • Ended Quarter with $25.9 million in Cash, Cash Equivalents and Marketable Securities
    CHARLOTTESVILLE, Va., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) (Diffusion or the Company), a biopharmaceutical company developing novel therapies that may enhance the bodys ability to deliver oxygen to areas where it is needed most, today announced financial results for the quarter ended September 30, 2022, and provided a business update.
  • The Company retained Canaccord Genuity LLC as its financial advisor and Dechert LLP as its legal counsel to assist with the review process.
  • Research and development expenses in the third quarter of 2022 were $0.8 million, compared to $2.1million in the prior year period.
  • General and administrative expenses were $2.1 million during the third quarter of 2022 versus $1.9million in the comparable quarter last year.

PDS Biotech Announces 100% Clinical Response in Cervical Cancer Patients in Preliminary Data from IMMUNOCERV Phase 2 Clinical Trial

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星期一, 十一月 14, 2022
Trial of the century, Communication, Survival, Neck, Lymph, National Cancer Institute, Type 1, CT scan, Cancer, Mayo Clinic, Disease, Radiation, PDS, Toxicity, Immunotherapy, Treatment, Vaccine, Cervical cancer, Blood, Partnership, PET, University, Neoplasm, Research, Nature, Society, MD Anderson Cancer Center, Biotechnology, COVID-19, Merck & Co., Vulvar cancer, Warfarin necrosis, NCI, Merck, MRI, Human, CD8, Sharp, Nominal interest rate, Clinical professor, Therapy, FIGO, CRT, CPI, Gamma ray, III, Risk, Infection, Merck Sharp & Dohme Federal Credit Union, PDSB, Positron emission tomography, CR, Head, SITC, Pharmaceutical industry, Medical imaging, Patient

FLORHAM PARK, N.J., Nov. 14, 2022 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced that updated clinical data from the ongoing IMMUNOCERV Phase 2 clinical trial was presented during a poster session on November 11 at the 37th Annual Meeting for the Society for Immunotherapy of Cancer (SITC 2022). These data expand upon results detailed in the abstract submitted to SITC 2022 that was released to the public on November 7.

Key Points: 
  • This includes 78% (7/9) of treated patients with advanced cervical cancer (FIGO stage III or IV).
  • 100% (9/9) of patients treated with the combination of PDS0101 and CRT had a clinical response with tumor shrinkage >60% at mid-point evaluation by MRI.
  • We look forward to the continued advancement of the IMMUNOCERV Phase 2 clinical trial and the opportunity to report updated data during 2023.
  • A third Phase 2 clinical trial in first-line treatment of locally advanced cervical cancer is being led by The University of Texas MD Anderson Cancer Center.

PDS Biotech Announces Presentation of Preliminary PDS0101 Efficacy, Safety, and Immunology Data at Society for Immunotherapy of Cancer (SITC 2022)

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星期一, 十一月 7, 2022
National Cancer Institute, Neck, Population, Sharp, PDSB, Cervical cancer, Clinical trial, National, Partnership, University, SEC, SITC, Company, Merck, CT scan, GLOBE, Radiation, NCI, Vulvar cancer, Immunotherapy, Clinical professor, CEO, CR, CRT, Forward-looking statement, Vaccine, CPI, Society, Cancer, Blood, PET, Research, Biotechnology, Toxicity, Risk, Neoplasm, PDS, Merck & Co., COVID-19, Nature, Review, Head, Infection, Positron emission tomography, Goal, Mayo Clinic, Therapy, Lymph, Safety, Trial of the century, Nasdaq, MD Anderson Cancer Center, Merck Sharp & Dohme Federal Credit Union, Center, Communication, Pharmaceutical industry, Medical imaging, Patient

FLORHAM PARK, N.J., Nov. 07, 2022 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced upcoming poster presentations of clinical data from two Phase 2 clinical trials of PDS0101 at the 37th Annual Meeting for the Society for Immunotherapy of Cancer (SITC 2022) being held November 8-12, 2022 in Boston. PDS0101 is PDS Biotech’s lead candidate being developed as a potential treatment for HPV-positive cancers.

Key Points: 
  • PDS0101 is PDS Biotechs lead candidate being developed as a potential treatment for HPV-positive cancers.
  • 8 of the 17 patients had completed a Day 170 post-treatment Positron Emission Tomography, Computed Tomography (PET CT) scan to assess the status of the cancer.
  • The 1-year overall survival is 100% (8/8) in patients treated with the combination of PDS0101 and CRT.
  • PDS Biotechs lead candidate, PDS0101, combines the utility of the Versamune platform with targeted antigens in HPV-expressing cancers.

Cerveau Technologies Inc. and LEXEO Therapeutics, Inc.- Sign Agreement to Provide Novel Tau Imaging Biomarker for Disease Modifier Research

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星期一, 十一月 7, 2022
Research, Seniors, Neurology, Other Health, Biotechnology, General Health, Pharmaceutical, Consumer, Health, Science, Technology, Neurodegeneration, Brain, Therapy, Trial of the century, Rapunzel's Tangled Adventure (season 2), Non-fungible token, Positron emission tomography, Patient, PET, Medical imaging, Pharmaceutical industry

NFTs made up of aggregated tau protein are a hallmark of several neurodegenerative diseases, including Alzheimers disease.

Key Points: 
  • NFTs made up of aggregated tau protein are a hallmark of several neurodegenerative diseases, including Alzheimers disease.
  • The collaboration is focused on using [F-18]MK-6240 as a biomarker in LEXEOs ongoing clinical study Protocol LX1001-01, an investigational gene therapy candidate for APOE4-associated Alzheimers disease.
  • Cerveau is pleased to be working with LEXEO to better understand Tau PETs utilization in supporting therapeutic trials, said Rick Hiatt, Chief Executive Officer, Cerveau Technologies, Inc.
  • Cerveaus vision is to globally develop diagnostics and technology that positively impact patients with neurodegenerative disorders including Alzheimers disease.

AHEAD STUDY IS FIRST TO TEST LECANEMAB TO DELAY OR PREVENT ALZHEIMER'S DISEASE SYMPTOMS AT THE STAGE OF PRECLINICAL AD

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星期三, 十一月 2, 2022
Amyloid, Plasma, Population, Headquarters, Clinical trial, Brain, Biomarker, Ageing, Research, PET, NIH, Harvard University, Risk, National Institute, Disease, Harvard Medical School, Safety, Neuroimaging, National, AD, Clarity, Biogen, BAN2401, Eisai, Dementia, NIA, Neurology, MCI, USC, ACTC, Multimedia, Clinical professor, SAN, Mayo Clinic, National Institute on Aging, Amnesia, Positron emission tomography, Medical imaging, Pharmaceutical industry, Online shopping, Alzheimer's disease

The AHEAD Study is the first ever clinical trial to test the effect of lecanemab (investigational antibody) in people who have no cognitive symptoms of Alzheimer's disease (AD), but in whom biomarker tests indicate amyloid is present in the brain, known as "preclinical" AD.

Key Points: 
  • The AHEAD Study is the first ever clinical trial to test the effect of lecanemab (investigational antibody) in people who have no cognitive symptoms of Alzheimer's disease (AD), but in whom biomarker tests indicate amyloid is present in the brain, known as "preclinical" AD.
  • The AHEAD Study is also the first AD trial to recruit people as young as 55 years old who are at risk of developing symptoms of AD as they get older.
  • The AHEAD Study will test whether the clinical effects reported in the Clarity AD clinically symptomatic population are similar in the AHEAD preclinical AD population.
  • "The AHEAD Study is testing lecanemab in a much earlier stage of AD than the Clarity AD trial," said Dr. Reisa Sperling, professor of neurology at Harvard Medical School, and co-principal investigator of the AHEAD Study.

World Nuclear Imaging Agents Market Report 2022: Regulatory and Reimbursements, Procedures, & Forecasts 2015-2030 Featuring Cardinal Health, GE Healthcare, Novartis, Bracco Imaging, DuPont de Nemours - ResearchAndMarkets.com

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星期二, 九月 20, 2022
Health, Other Health, Photon, Single-photon emission computed tomography, COVID-19, Epidemiology, Country, PET/MRI, Diagnosis, Nuclear, PET/CT, ASP, Review, CMO, Industry, Strategic planning, Segment, Volume, Investment, PET, GlobalData, Region, Medical imaging, SPECT, SWOT, Cancer, Positron emission tomography, SPECT/CT, SWOT analysis, Renewable energy, Retail, Public relations, Forecast

The model discusses in detail the impact of COVID-19 on Nuclear Imaging Agents market for the year 2020 and beyond.

Key Points: 
  • The model discusses in detail the impact of COVID-19 on Nuclear Imaging Agents market for the year 2020 and beyond.
  • Nuclear Imaging is a noninvasive medical technique which uses radioactive tracers (generally F-18 Fluorodeoxyglucose) to assess and diagnose bodily functions and diseases.
  • Nuclear Imaging Agent's have been classified into Positron Emission Tomography (PET) Systems and Single Photon Emission Computed Tomography (SPECT) Systems.
  • Track device sales in the global and country-specific Nuclear Imaging Agents market from 2015-2030.

With 5.41% CAGR, Molecular Imaging Market Size to Hit USD 7.3 Billion by 2032 | Future Market Insights

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星期三, 九月 14, 2022
Photon, Siemens, Single-photon emission computed tomography, Conditional sentence, Siemens Healthineers, Adoption, Health, Cardiology, Time, Molecular imaging, Gynaecology, Hospital, Philips, Prevalence, Functional neurologic disorder, Acquisition, Growth, Biotelemetry, Isotopia Festival, Industry, Deep learning, Canon Medical Systems Corporation, Lung cancer, PET, Degenerative disease, Cancer, Lung nodule, Bruker, Technology, FMI, Lists of diseases, Market, CT, Diagnosis, SPECT, Health care, Awareness, Lists of countries and territories, Globe, Radiology, Positron emission tomography, CAGR, Agriculture, Medical imaging, Fine chemical, Renewable energy, Software

NEWARK, Del., Sept. 14, 2022 /PRNewswire/ -- The global molecular imaging market is anticipated to value at US$ 7.3 Billion while expanding at a CAGR of 5.41% during the forecast period of 2022-2032. The growth of the market can be attributed to the increasing incidences of chronic illness across the globe.

Key Points: 
  • Growing Adoption of AI-Based Technology in the Healthcare Sector to Expand the Molecular Imaging Market at a CAGR of 5.41% by 2032.
  • In Europe, the molecular imaging market is expected to display a CAGR of 4% during the forecast period.
  • Key Takeaways from the Market Study:
    The global molecular imaging market is expected to secure US$ 4.309 Billion in 2022.
  • Future Market Insights,in its new offering, presents an unbiased analysis of the global molecular imaging market, presenting a historical analysis from 2017 to 2021 and forecast statistics for the period of 2022-2032.