FRCPC

Lupus Foundation of America and Lupus Canada Award Grant for Study Examining New Method to Predict Treatment Response in Lupus Nephritis to Improve Kidney Outcomes

Retrieved on: 
Monday, August 28, 2023

Dr. Wither will be examining an inflammatory marker called IFN-induced genes in patients with lupus nephritis (lupus-related kidney disease).

Key Points: 
  • Dr. Wither will be examining an inflammatory marker called IFN-induced genes in patients with lupus nephritis (lupus-related kidney disease).
  • "The Lupus Canada Catalyst Award from the Lupus Foundation of America and Lupus Canada is allowing us to take critical steps in this research, which has the potential to improve kidney outcomes in patients with lupus nephritis."
  • "Dr. Wither's research on IFN-induced genes in patients with lupus nephritis holds the promise to revolutionize evaluation of lupus kidney biopsies and treatment strategies to improve kidney outcomes."
  • "Today's announcement between Lupus Canada and Lupus Foundation of America will kick start critical research into lupus nephritis clinical testing, with hope to improve treatment outcomes," said Thomas J. Simpson, Chair of Lupus Canada.

Quanta™ Announces Enrollment Completion in Home Run Study

Retrieved on: 
Thursday, August 17, 2023

BEVERLY, Mass., Aug. 17, 2023 /PRNewswire/ -- Quanta Dialysis Technologies® today announced that it has completed enrollment of its Home Run study for at-home hemodialysis. The Home Run study is a prospective, multi-center, open-label trial to assess the efficacy and safety of the Quanta Dialysis System for home hemodialysis. Results are expected to be announced in the second half of 2023.

Key Points: 
  • BEVERLY, Mass., Aug. 17, 2023 /PRNewswire/ -- Quanta Dialysis Technologies® today announced that it has completed enrollment of its Home Run study for at-home hemodialysis.
  • The Home Run study is a prospective, multi-center, open-label trial to assess the efficacy and safety of the Quanta Dialysis System for home hemodialysis.
  • Results are expected to be announced in the second half of 2023.
  • Enrollment completion is the first step forward in a potential new alternative for people with this life-threatening disease."

Apex Labs announces the appointment of Chief Medical Officer & Chief Commercial Officer

Retrieved on: 
Thursday, August 10, 2023

VANCOUVER, BC, Aug. 10, 2023 /PRNewswire/ - Apex Labs Ltd. (APEX or the Company), a pharmaceutical company transforming the standard of mental health care with clinically proven psilocybin treatments, announces the addition of two new executives to the c-suite, psychiatrist Dr. Mark Johnston, MD, FRCPC, as Chief Medical Officer and Greg Rutherford as Chief Commercial Officer.

Key Points: 
  • VANCOUVER, BC, Aug. 10, 2023 /PRNewswire/ - Apex Labs Ltd. (APEX or the Company), a pharmaceutical company transforming the standard of mental health care with clinically proven psilocybin treatments, announces the addition of two new executives to the c-suite, psychiatrist Dr. Mark Johnston, MD, FRCPC, as Chief Medical Officer and Greg Rutherford as Chief Commercial Officer.
  • Dr. Johnston, APEX CMO has been practicing psychiatry for over 20 years running a private Veteran-focused network of mental health clinics.
  • He has been the principal investigator on over 25 central nervous system clinical trials, including trials in depression, bipolar disorder, ADHD, OCD, and Alzheimer's dementia.
  • Most recently he was the Medical Director of CNS Research at Centricity Clinical Trials.

ChromaCode and Protean BioDiagnostics Establish Strategic Partnership to Introduce a HDPCR-based NSCLC Assay in the U.S.

Retrieved on: 
Thursday, August 10, 2023

This partnership's goal is to introduce a non-small cell lung cancer (NSCLC) assay, based on ChromaCode's state-of-the-art High Definition PCR (HDPCR™) multiplexing technology, via an early access program.

Key Points: 
  • This partnership's goal is to introduce a non-small cell lung cancer (NSCLC) assay, based on ChromaCode's state-of-the-art High Definition PCR (HDPCR™) multiplexing technology, via an early access program.
  • HDPCR™ represents an innovative approach to deep multiplexing of biomarkers in a single, rapid, cost-effective assay for multiple sample types.
  • Designed for applications in oncology, minimal residual disease, transplant, and noninvasive prenatal testing, the HDPCR™ technology simplifies workflows and reduces processing times.
  • "This strategic partnership with Protean marks a significant step towards bringing the HDPCR NSCLC assay to Florida, a state accounting for approximately 10% of cancer incidence in the US," said Padma Sundar, Chief Business Officer of ChromaCode.

Quanta™ Receives FDA 510(k) Clearance for Expanded Indication of Continuous Renal Replacement Therapies

Retrieved on: 
Thursday, August 3, 2023

BEVERLY, Mass., Aug. 3, 2023 /PRNewswire/ -- Quanta Dialysis Technologies®, a medical technology company committed to making kidney care more accessible, today announced that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for an expanded indication of the Quanta Dialysis System, a compact and easy-to-use hemodialysis device, for two modalities of continuous renal replacement therapy (CRRT): continuous venovenous hemodialysis (CVVHD) and slow continuous ultrafiltration (SCUF). Under the new 510(k), the Quanta Dialysis System is the only dialysis device FDA-cleared to provide intermittent hemodialysis (IHD), sustained low efficiency dialysis (SLED) or bagless CRRT which creates dialysate on demand – all in a single machine.

Key Points: 
  • The Quanta Dialysis System is the only dialysis device FDA-cleared to perform IHD, SLED or CRRT - all in a one platform.
  • The Quanta Dialysis System was originally designed to serve the more than two million people with end-stage kidney disease (ESKD) worldwide who receive treatment with dialysis or a kidney transplant.
  • It features dialysate flow rates from 50 to 500 mL/min and treatment times up to 24 hours of continuous delivery.
  • "This clearance is a true game-changer for acute care settings," said Quanta Chief Executive Officer, Alejandro Galindo.

MITSUBISHI TANABE PHARMA CANADA ANNOUNCES THAT COMPANY'S ORAL TREATMENT FORMULATION FOR AMYOTROPHIC LATERAL SCLEROSIS (ALS) HAS BEEN ADDED TO THE PROVINCIAL DRUG PLAN IN ONTARIO

Retrieved on: 
Tuesday, August 1, 2023

RADICAVA® Oral Suspension was authorized by Health Canada on November 8, 2022.

Key Points: 
  • RADICAVA® Oral Suspension was authorized by Health Canada on November 8, 2022.
  • To date, it is estimated that the majority of private insurance plans in the country cover RADICAVA® Oral Suspension.
  • MTP-CA continues to have discussions with other provinces, territories and federal agencies regarding the listing of RADICAVA® Oral Suspension under additional publicly funded drug programs.
  • The reimbursement criteria for RADICAVA® Oral Suspension are the same as for RADICAVA® IV, which can be found on the Ontario Ministry of Health's Exceptional Access Program webpage.

Route 92 Medical Announces Publication of a Retrospective Study in the Interventional Neuroradiology Journal

Retrieved on: 
Monday, July 31, 2023

SAN MATEO, Calif., July 31, 2023 (GLOBE NEWSWIRE) -- Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced the publication of a first-in-human study featuring the FreeClimb® 70 reperfusion system in the Interventional Neuroradiology Journal.

Key Points: 
  • SAN MATEO, Calif., July 31, 2023 (GLOBE NEWSWIRE) -- Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced the publication of a first-in-human study featuring the FreeClimb® 70 reperfusion system in the Interventional Neuroradiology Journal.
  • “Route 92 Medical is focused on refining stroke intervention with a suite of solutions designed to simplify endovascular thrombectomy procedures and ultimately improve patient outcomes,” said Tony Chou, CEO of Route 92 Medical.
  • The study included 30 consecutive patients and showed an M1 FPE of 61%, one of the highest endovascular thrombectomy FPE rates ever published.
  • “Its rapid delivery, effectiveness and safety profile, combined with its efficiency, make it an exceptional advancement in stroke intervention technology.”
    For more information about Route 92 Medical and the FreeClimb 70 reperfusion system, visit www.route92medical.com .

Heart Checkups Advised for Kids Who Play Sports

Retrieved on: 
Friday, July 28, 2023

Pre-participation heart screenings are advised for athletes ages 12 and above.

Key Points: 
  • Pre-participation heart screenings are advised for athletes ages 12 and above.
  • Heart defects don’t prohibit kids from playing sports.
  • An example of an acquired abnormality is myocarditis, an inflammation of the heart that can develop from a viral illness.
  • Dr. Kantor and his colleagues often see kids who are referred to the Heart Institute after a checkup by their pediatrician flags a heart issue that could pose a risk during intense exertion.

Dana Foundation Appoints Two New Board Members

Retrieved on: 
Tuesday, July 18, 2023

NEW YORK, July 18, 2023 /PRNewswire/ -- The Dana Foundation is pleased to announce the addition of two members to its board of directors: Paula A. Kerger and Husseini Manji, M.D., FRCPC.

Key Points: 
  • New Members Bring Expertise in Media, Education, Neuroscience, and Technology
    NEW YORK, July 18, 2023 /PRNewswire/ -- The Dana Foundation is pleased to announce the addition of two members to its board of directors: Paula A. Kerger and Husseini Manji, M.D., FRCPC.
  • "The Board is delighted to welcome two extremely distinguished and highly effective new directors to its ranks," said Steven E. Hyman, M.D., chairman of the Dana Foundation.
  • "Our newly elected board members each bring unique perspectives from different fields and organizations, which will enrich the interdisciplinary focus of the Dana Foundation," said Caroline Montojo, Ph.D., president of the Dana Foundation.
  • Kerger and Manji will join the following Dana Foundation board members: Steven E. Hyman, Edward Bleier, Wallace L. Cook, Charles A. Dana III, Hildegarde E. Mahoney, and Peter A. Nadosy.

Alnylam Reports Updated Positive Interim Phase 1 Results for ALN-APP, in Development for Alzheimer’s Disease and Cerebral Amyloid Angiopathy

Retrieved on: 
Monday, July 17, 2023

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) announced today updated positive interim results for the ongoing single ascending dose portion of the Phase 1 study of ALN-APP, an investigational RNAi therapeutic targeting amyloid precursor protein (APP) in development for the treatment of Alzheimer’s disease and cerebral amyloid angiopathy (CAA).

Key Points: 
  • Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) announced today updated positive interim results for the ongoing single ascending dose portion of the Phase 1 study of ALN-APP, an investigational RNAi therapeutic targeting amyloid precursor protein (APP) in development for the treatment of Alzheimer’s disease and cerebral amyloid angiopathy (CAA).
  • The results were presented at the 2023 Alzheimer’s Association International Conference (AAIC) being held July 16-20, 2023 in Amsterdam, The Netherlands.
  • ALN-APP is being developed in collaboration with Regeneron Pharmaceuticals, Inc.
    Twenty patients with early-onset Alzheimer’s disease have been enrolled in three single-dose cohorts in Part A of the ongoing Phase 1 study.
  • In this study to date, single doses of ALN-APP, which are administered by intrathecal injection, have been well tolerated.