JAMA

New Study Published in JAMA Neurology Affirms High Diagnostic Accuracy of ALZpath's pTau217 Test in Identifying Amyloid and Tau in the Brain

Retrieved on: 
Monday, January 22, 2024
Cerebrospinal fluid, Classification, Pathology, Research, Diagnosis, CSF, Neuro, PET, Immunoassay, University, Amyloid, JAMA, Plasma, AUC, Biomarker, Neurology, Single, Brain, Test management, Blood, Medical imaging

CARLSBAD, Calif., Jan. 22, 2024 /PRNewswire/ -- ALZpath, Inc. (ALZpath), a leader in Alzheimer's diagnostics, announced new findings published online today in JAMA Neurology showing that its proprietary blood-based biomarker assay for phosphorylated tau at residue 217 (pTau217) delivers high diagnostic accuracy and consistency in identifying amyloid and tau in the brain. The article, "Diagnostic Accuracy of a Plasma Phosphorylated Tau 217 Immunoassay for Alzheimer's Disease Pathology," was authored by Dr. Nicholas Ashton and colleagues from the University of Gothenburg, Sweden.

Key Points: 
  • With the novel ALZpath pTau217 assay and test, ALZpath is transforming Alzheimer's disease diagnosis and monitoring, providing accurate and accessible tools for researchers and healthcare professionals worldwide.
  • The ALZpath pTau217 assay showed high diagnostic accuracy in identifying elevated amyloid (AUC, 0.92-0.96; 95%CI 0.89-0.99) and tau (AUC, 0.93-0.97; 95%CI 0.84-0.99) in the brain across all cohorts.
  • Longitudinally, ALZpath's pTau217 test in blood showed an annual increase in individuals with amyloid plaques, with the highest increase observed in those who also had tau pathology.
  • The ALZpath pTau217 test will also be commercially available on other research and diagnostic platforms in support of global accessibility and scalability.

Geneoscopy Files Inter Partes Review Petition Challenging Exact Sciences’ Patent

Retrieved on: 
Friday, January 12, 2024
Legal, Biotechnology, Oncology, General Health, Health, Medical Devices, Professional Services, Other Health, Blood, Mortality, Patient, Cohort (statistics), Incidence, RNA, Cancer, American Medical Association, District court, JAMA, Journal, FDA, Dicarboxylic acid, Patent, CRC, Colorectal cancer, Motion, Exact sciences, AA, Trial of the century

Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that it has petitioned the United States Patent and Trademark Office (USPTO) for inter partes review challenging the patentability of United States Patent No.

Key Points: 
  • Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that it has petitioned the United States Patent and Trademark Office (USPTO) for inter partes review challenging the patentability of United States Patent No.
  • 11,634,781 (“the ’781 patent”) owned by Exact Sciences.
  • The fecal tests for detecting blood protein and nucleic acids recited by the claims were known and routine.
  • The claimed method of the ’781 patent is obvious, and the claims directed to the method are invalid.

Trifecta: A Leading Force in Organic Meal Delivery, Takes Center Stage in Netflix Documentary

Retrieved on: 
Thursday, January 4, 2024
Garder, Economic development, Oceanic, Stanford University, Entrepreneurship, Academy Awards, Research, Apolipoprotein, Diet, Health, Insulin, DNA, Twin, Trifecta, Netflix, Food, JAMA, OPS, Human, Environment, Dietary supplement

The documentary, “You Are What You Eat: A Twin Experiment” sheds light on the critical importance of mindful eating and the impact of diet on our bodies.

Key Points: 
  • The documentary, “You Are What You Eat: A Twin Experiment” sheds light on the critical importance of mindful eating and the impact of diet on our bodies.
  • Produced by Academy Award-winning Director Luis Psihoyos, the series delves into a groundbreaking diet study conducted by Stanford Professor Dr. Christopher Gardner featured in JAMA .
  • The research involved twins following different diets: one consumed an omnivorous diet, while the other adopted a vegan diet.
  • As Trifecta continues to redefine the meal delivery landscape, this documentary serves as a powerful reminder of the impact our food choices have on our well-being and the environment.

AC Immune’s Targeted Anti-pTau Active Immunotherapy for Alzheimer’s Disease Advances into Phase 2b Trial

Retrieved on: 
Friday, December 15, 2023
Partnership, AC, Deficit spending, Johnson & Johnson, Janssen Pharmaceuticals, Function (mathematics), Biomarker, FDA, Janssen, Injection, Biologics license application, Clinical trial, CHF, Dementia, JAMA, Pathology, Neurotoxicity, Patient, MCI, Memory, Tauopathy, BLA, Vaccine

ACI-35.030 is an investigational targeted active immunotherapy, selective for pathological phosphorylated Tau (pTau).

Key Points: 
  • ACI-35.030 is an investigational targeted active immunotherapy, selective for pathological phosphorylated Tau (pTau).
  • Studies have shown that pTau correlates with AD progression and the trial aims to show that ACI-35.030 can prevent or slow down the progression of tau pathology and onset of clinical symptoms.
  • The partnership with Janssen aims to develop and commercialize therapeutic anti-Tau active immunotherapies for the treatment of AD and potentially other Tauopathies.
  • It is sensitive enough to detect early changes in cognitive function, even before the first clinical signs of mild cognitive impairment (MCI) are apparent2.

Study Estimates a 23% Increase in COPD by 2050, Representing 600 Million Patients Globally

Retrieved on: 
Thursday, December 7, 2023
Urinary tract infection, JAMA, ASX, Risk, Woman, COPD, Prevalence, Disease, Lung cancer, SAN, RMD, Education, Gestational sac, Low, Air pollution, Emphysema, Chronic obstructive pulmonary disease, American Medical Association, JAMA Network Open, Tobacco smoking, World Health Organization, ResMed, Growth, Patient, Bronchitis, Journal, Female, Dust, Pharmaceutical industry

According to the World Health Organization , COPD is the third deadliest disease in the world.

Key Points: 
  • According to the World Health Organization , COPD is the third deadliest disease in the world.
  • Today, there are an estimated 480 million people who suffer from COPD.
  • This study in JAMA Network Open projects the increased regional and global burden of COPD by 2050 through an analysis of historical COPD prevalence and data on COPD risk factors such as tobacco smoking, outdoor air pollution, and household air pollution.
  • “The disproportionate growth of COPD among women is a critical finding as COPD has not always been as prevalent in women.

Junshi Biosciences Announces New Chemical Entity Application for Toripalimab Accepted by Australia’s TGA

Retrieved on: 
Saturday, December 2, 2023
Orbis, Marketing, Clutch (eggs), NPC, JAMA, Nasopharyngeal carcinoma, Risk, Ministry, OCE, ASCO, Shanda, Radiation, HSA, FDA, Dor, New chemical entity, European, Progression-free survival, Society, Cisplatin, NCE, MHRA, Cancer, Head, Death, American Medical Association, Health Canada, HC, World Health Organization, Primary tumor, Patient, Therapeutic Goods Administration, Safety, PFS, Journal, TGA, Pharmaceutical industry

Additionally, the TGA has also granted an orphan drug designation to toripalimab for the treatment of NPC.

Key Points: 
  • Additionally, the TGA has also granted an orphan drug designation to toripalimab for the treatment of NPC.
  • At present, seven other regulatory agencies have joined Project Orbis, including the TGA, Singapore Health Sciences Authority (HSA), Health Canada (HC), MHRA, etc.
  • Toripalimab for the treatment of NPC meets these application requirements and is the first domestic oncology drug to be included in Project Orbis.
  • Junshi Biosciences will explore the possibility of fast marketing in these countries and regions where the pathway is applicable.

WAINUA™ (eplontersen) Granted First-Ever Regulatory Approval in the US for the Treatment of Adults With Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis

Retrieved on: 
Friday, December 22, 2023
Research, FDA, Neurology, Genetics, Clinical Trials, Biotechnology, Health, Pharmaceutical, Science, Quality of life, Tissue, Heart, Heredity, Serum, Polyneuropathy, Death, Inotersen, Ageing, TTR, JAMA, Vitamin A, Diagnosis, Metabolism, Amyloidosis, Pancreas, Disease, Safety, Journal, Heart failure, Disability studies, Sympathetic nervous system, Vitamin A deficiency, Food, Biopharmaceutical, AstraZeneca, Caregiver, ATTR, Patient, Medicine, LICA, Ionis, American Medical Association, Growth, Central nervous system, Pharmaceutical industry

It is also a pivotal moment for Ionis as WAINUA will be the first in a steady cadence of potential commercial launches for the company.

Key Points: 
  • It is also a pivotal moment for Ionis as WAINUA will be the first in a steady cadence of potential commercial launches for the company.
  • Reduced Serum Vitamin A Levels and Recommended Supplementation WAINUA leads to a decrease in serum vitamin A levels.
  • Refer patient to an ophthalmologist if ocular symptoms suggestive of vitamin A deficiency occur.
  • Please see link to US Full Prescribing Information for WAINUA.

WAINUA™ (eplontersen) granted regulatory approval in the U.S. for the treatment of adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis

Retrieved on: 
Thursday, December 21, 2023
Quality of life, LICA, Food, AstraZeneca, Caregiver, Ionis Pharmaceuticals, FDA, Amyloidosis, Disease, ATTR, Serum, Polyneuropathy, Death, American Medical Association, Disability studies, TTR, JAMA, Patient, Diagnosis, IONS, Medicine, Journal, Heart failure, Neurology, Pharmaceutical industry

WAINUA is the only approved medicine for the treatment of ATTRv-PN that can be self-administered via an auto-injector.

Key Points: 
  • WAINUA is the only approved medicine for the treatment of ATTRv-PN that can be self-administered via an auto-injector.
  • "Approval of WAINUA represents a meaningful advancement in treatment, one that gives those who are living with transthyretin-mediated amyloid polyneuropathy help managing the disease."
  • WAINUA is a ligand-conjugated antisense oligonucleotide (LICA) medicine designed to reduce the production of TTR protein at its source.
  • "There is an urgent medical need for new therapies for people living with hereditary transthyretin-mediated amyloid polyneuropathy," said Ruud Dobber, executive vice president, BioPharmaceuticals Business Unit, AstraZeneca.

Achieve Life Sciences Reports Financial Results for Third Quarter and Provides Corporate Update

Retrieved on: 
Thursday, November 9, 2023
NDA, Small business, Webcast, Smoker, Annual general meeting, Herbal cigarette, U.S.–Canada Team Tournament (Go), International, Headache, ASP, FDA, Nicotine, Smoke, Pharmacokinetics, New Drug Application, Data analysis, American Society of Pharmacognosy, Cytisine, Nausea, Kidney, Insomnia, Society, JAMA, Smoking, Pharmaceutical industry, Cryptocurrency

“This has been a pivotal year for Achieve and we made significant strides to continue our progress on advancing cytisinicline throughout the third quarter,” said John Bencich, CEO of Achieve.

Key Points: 
  • “This has been a pivotal year for Achieve and we made significant strides to continue our progress on advancing cytisinicline throughout the third quarter,” said John Bencich, CEO of Achieve.
  • This trial, conducted in the United States, showcased the effectiveness and excellent tolerability of cytisinicline in adult smokers.
  • The panel highlighted the importance of industry and public partnerships in advancing new treatments, with Achieve representing an exemplary example.
  • Data analysis and final study reports for all 3 studies are expected to be completed in early 2024.

FRUZAQLA™ (fruquintinib) Now Available from Onco360 for the Treatment of Adult Patients with Metastatic Colorectal Cancer (mCRC)

Retrieved on: 
Tuesday, November 21, 2023
Oncology, Health, Clinical Trials, Research, Pharmaceutical, Science, Lancet, National Cancer Institute, Jazz Pharmaceuticals, Takeda, CRC, Specialty pharmacy, Anti-VEGF, VEGFR-3, Mortality, Patient, Pharmacy, Large intestine, VEGF, Caregiver, PharMerica, Colorectal cancer, Cancer, Diagnosis, Metastasis, Death, Hospital, Irinotecan, JAMA, Pharmaceutical industry

Fruzaqla™ is a selective oral inhibitor of VEGFR-1, VEGFR-2, and VEGFR-3, which play a pivotal role in blocking tumor angiogenesis.

Key Points: 
  • Fruzaqla™ is a selective oral inhibitor of VEGFR-1, VEGFR-2, and VEGFR-3, which play a pivotal role in blocking tumor angiogenesis.
  • Colorectal cancer is the fourth most frequent diagnosed cancer and second leading cause of death in the U.S.
  • Fruquintinib vs Placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): an international, multicenter, randomized double blind, phase 3 study.
  • Effect of fruquintinib vs Placebo on overall survival in patients with previously treated metastatic colorectal cancer.