Institutional review board

WCG Raises the Bar in Quality Management Standards, Becoming ISO 9001 Certified in both IRB and IBC

Retrieved on: 
Tuesday, October 10, 2023
Certification, ISO, BSI, WCG, IBC, IRB, Institutional review board, JD, CIP, MA, Audit, Management

WCG has now achieved ISO 9001 certification for both its Institutional Review Board (IRB) and IBC services – reinforcing its commitment to excellence of quality management across ethical review.

Key Points: 
  • WCG has now achieved ISO 9001 certification for both its Institutional Review Board (IRB) and IBC services – reinforcing its commitment to excellence of quality management across ethical review.
  • "In 2010, WCG's IRB became the only IRB in the world to have met ISO quality management standards and to have received ISO 9001 certification," commented WCG Chief Executive Officer Sam Srivastava.
  • "Today, we are proud to raise the bar yet again as we have set a new high standard for quality management in ethical review within our IBC."
  • "WCG has been leading ethical review for decades," added David Forster, JD, MA, CIP, Chief Compliance Officer, WCG.

Creative Medical Technology Holdings Announces IRB Approval for FDA Cleared Phase 1/2 Clinical Trial of StemSpine® using AlloStem™ ("CELZ-201-DDT") Novel Cell Therapy to Treat Chronic Lower Back Pain

Retrieved on: 
Tuesday, October 10, 2023
National library, Biomedical Research, Endocrinology, Standard of care, Degenerative disc disease, Institutional review board, Safety, Human, Elective surgery, FDA, Immunotherapy, IRB, Gynaecology, Urology, Clinical trial, Back pain, United States National Library of Medicine, Quality of life, Pharmaceutical industry

PHOENIX, Oct. 10, 2023 /PRNewswire/ -- Creative Medical Technology Holdings, Inc. ("Creative Medical Technology" or the "Company") (NASDAQ: CELZ), a biotechnology company focused on a regenerative approach to immunotherapy, endocrinology, urology, gynecology, and orthopedics, today announced that it has received Institutional Review Board ("IRB") approval to proceed with its clinical trial for the treatment of chronic lower back pain with its StemSpine® procedure using AlloStem™ ("CELZ-201-DDT") cell therapy.

Key Points: 
  • The study will enroll 30 individuals suffering from chronic lower back pain caused by Degenerative Disc Disease.
  • An IRB is an FDA-registered consortium that has been formally designated to review and monitor biomedical research involving human subjects.
  • "We are pleased to announce the expeditious receipt of this vital next step in commencing the clinical trial for CELZ-201-DDT," said Timothy Warbington, CEO of Creative Medical Technology.
  • "Studies show that 8% of all adults in the United States, approximately 16 million people, experience chronic lower back pain.

BriaCell Initiates Pivotal Phase 3 Study of Bria-IMT™ in Advanced Metastatic Breast Cancer

Retrieved on: 
Tuesday, October 3, 2023
Biologics license application, Communication, Institutional review board, Survival, Immunotherapy, Patient, IRB, TSX, FDA, Therapy, BCT, Safety, Disease, Pharmaceutical industry

Positive completion of the pivotal study, following review by FDA, could lead to full approval of the Bria-IMT™ immune checkpoint inhibitor combination in advanced metastatic breast cancer.

Key Points: 
  • Positive completion of the pivotal study, following review by FDA, could lead to full approval of the Bria-IMT™ immune checkpoint inhibitor combination in advanced metastatic breast cancer.
  • The study will enroll 177 patients in the Bria-IMT™ combination therapy arm and 177 patients in the treatment of physician’s choice arm.
  • We expect frequent and responsive FDA communication under our Fast Track status during our pivotal Phase 3 study.
  • The successful completion of the pivotal study would allow BriaCell to subsequently submit a Biologics License Application and accelerate the path to commercialization.

Lifshitz Law PLLC Announces Investigations of ImmunityBio, Inc. (NASDAQ: IBRX), BioXcel Therapeutics, Inc. (NASDAQ: BTAI), Baxter International Inc. (NYSE: BAX)

Retrieved on: 
Sunday, October 1, 2023
GMP, Institutional review board, Face, Telephone, CMOS, Record, Dementia, Patient, Advertising, BAX, FDA, ImmunityBio COVID-19 vaccine, Agitation, Hewlett, Safety, Online shopping

NEW YORK, Sept. 30, 2023 (GLOBE NEWSWIRE) --

Key Points: 
  • If you are an IBRX investor, and would like additional information about our investigation, please complete the Information Request Form or contact Joshua Lifshitz, Esq.
  • If you are a BTAI investor, and would like additional information about our investigation, please complete the Information Request Form or contact Joshua Lifshitz, Esq.
  • The law firm responsible for this advertisement is Lifshitz Law PLLC, 1190 Broadway, Hewlett, New York 11557, Tel: (516) 493-9780.
  • Prior results do not guarantee or predict a similar outcome with respect to any future matter.

Investigation Alert BAX, DHR, BTAI, and IBRX: Johnson Fistel, LLP Encourages Long-Term Investors to Submit Their Information Below

Retrieved on: 
Tuesday, September 26, 2023
GMP, LLP, Institutional review board, Good manufacturing practice, Baxter International, CMOS, Record, DHR, Research, Danaher Corporation, Complaint, Dementia, Patient, FDA, Therapy, BLA, NYSE, Agitation, Food, Safety, Pharmaceutical industry, Management

Defendants’ failure to disclose Baxter’s true problems relating to its supply chain deceived investors about the Company’s true financial health and earnings.

Key Points: 
  • Defendants’ failure to disclose Baxter’s true problems relating to its supply chain deceived investors about the Company’s true financial health and earnings.
  • Johnson Fistel, LLP is investigating potential claims on behalf of Danaher Corporation (NYSE: DHR) against certain of its officers and directors.
  • Johnson Fistel, LLP is investigating potential claims on behalf of BioXcel Therapeutics, Inc. (NASDAQ: BTAI) against certain of its officers and directors.
  • Johnson Fistel, LLP is investigating potential claims on behalf of ImmunityBio, Inc. (NASDAQ: IBRX) against certain of its officers and directors.

Orchestra BioMed Granted FDA Approval of IDE to Initiate BACKBEAT Pivotal Study of BackBeat CNT™ for the Treatment of Hypertension in Pacemaker Patients

Retrieved on: 
Tuesday, September 19, 2023
Blood pressure, HTN, Orchestra, MDT, Institutional review board, Freedom, Press release, HOPE, OSBP, Division, Beat (music), Treatment, GA, Bradycardia, Cardiac electrophysiology, Cooper University Hospital, Patient, Collection, Video news release, Comorbidity, Risk, Physician, CNT, Webcast, IDE, FDA, Death, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, NYSE, Food, Pharmaceutical industry, Medical device, Medtronic, Cardiology, Hypertension

Orchestra BioMed and Medtronic plc (NYSE: MDT) formed a strategic collaboration for the development and commercialization of AVIM therapy for hypertensive pacemaker patients in July 2022.

Key Points: 
  • Orchestra BioMed and Medtronic plc (NYSE: MDT) formed a strategic collaboration for the development and commercialization of AVIM therapy for hypertensive pacemaker patients in July 2022.
  • Under the collaboration, Medtronic is providing Orchestra BioMed with development, clinical, and regulatory support for the BACKBEAT global pivotal study, which Orchestra BioMed is sponsoring.
  • Orchestra BioMed will share in the revenues generated from Medtronic sales of the AVIM-enabled pacing systems.
  • “We are thrilled to receive IDE approval from the FDA and move forward with plans to initiate the BACKBEAT global pivotal study, which is designed to support potential future regulatory review and potential approval of AVIM therapy for hypertensive patients indicated for a pacemaker.

MedRhythms Selects Curavit as its Contract Research Organization (CRO) for a Chronic Stroke Decentralized Clinical Trial

Retrieved on: 
Wednesday, September 20, 2023
Single-frequency network, Music, Partnership, Institutional review board, Success, Clinical trial, Research, Brain, DCT, DCTS, Walking, RAS, Patient, IRB, Orchestra, Outcome, Health, Pharmaceutical industry, Stroke

NEW YORK, Sept. 20, 2023 /PRNewswire/ -- Curavit Clinical Research, a virtual contract research organization (VCRO) that specializes in decentralized clinical trials (DCTs) for digital therapeutics (DTx), announced that it was selected as the VCRO for a study of MR-001, MedRhythms' neurorehabilitation system designed to improve walking and ambulation in adults with chronic stroke walking impairments. The goal of the study is to further characterize the long-term economic and clinical benefits of MR-001 beyond what has been established in a multi-center, randomized clinical trial. This will also include evaluating patient engagement and therapeutic response durability.  

Key Points: 
  • The goal of the study is to further characterize the long-term economic and clinical benefits of MR-001 beyond what has been established in a multi-center, randomized clinical trial.
  • Curavit is responsible for managing all aspects of MedRhythms' hybrid decentralized clinical trial (DCT) – from protocol finalization and Institutional Review Board (IRB) approvals to patient recruitment, testing at physical sites, remote site and patient monitoring and healthcare economics and outcomes analysis.
  • Health economics research quantifies the long-term financial impact for patients, providers, and payers," said Owen McCarthy, President and co-founder of MedRhythms.
  • MR-001 is based on Rhythmic Auditory Stimulation (RAS), a clinical intervention utilizing the mechanism of auditory-motor entrainment ("entrainment").

Redwood Scientific Technologies Inc. (RSCI.OTC.PK) Announces Successful S1 Registration Filing and Provides Updates on TBX FREE Clinical Trial Progress

Retrieved on: 
Monday, September 18, 2023
Institutional review board, Security (finance), Food and Drug Administration Amendments Act of 2007, Clinical trial, FDA, TBX, IRB, Food, Pharmaceutical industry

NEW YORK, Sept. 18, 2023 /PRNewswire/ -- Redwood Scientific Technologies is delighted to announce the successful filing of its S1 registration statement with the Securities and Exchange Commission (SEC).

Key Points: 
  • NEW YORK, Sept. 18, 2023 /PRNewswire/ -- Redwood Scientific Technologies is delighted to announce the successful filing of its S1 registration statement with the Securities and Exchange Commission (SEC).
  • The company has received confirmation from the SEC, affirming the completion of this important milestone.
  • Redwood Scientific Technologies files S1 and updates on Clinical Trial process.
  • Mr. Cardiff further provided updates on the progress of the clinical trials process for TBX FREE and TBX VAPE FREE.

Positron Corporation Announces Start of Clinical Study of Affinity PET-CT Device

Retrieved on: 
Friday, September 8, 2023
Ochsner Health System, Institutional review board, Federal Food, Drug, and Cosmetic Act, Investigational device exemption, POSC, International Committee for the Nanking Safety Zone, Molecular imaging, Positron Corporation, Trial of the century, Register, Documentation, Patient, Physician, OTC, Affinity, FDA, Medical imaging, Positron

Niagara Falls, NY, Sept. 08, 2023 (GLOBE NEWSWIRE) -- Positron Corporation (“Positron” or the “Company”) (OTC: POSC), a leading molecular imaging medical device company, is pleased to announce that the Company will begin its clinical study of its Affinity™ PET-CT imaging device with Ochsner Clinic Foundation in New Orleans, LA.

Key Points: 
  • Niagara Falls, NY, Sept. 08, 2023 (GLOBE NEWSWIRE) -- Positron Corporation (“Positron” or the “Company”) (OTC: POSC), a leading molecular imaging medical device company, is pleased to announce that the Company will begin its clinical study of its Affinity™ PET-CT imaging device with Ochsner Clinic Foundation in New Orleans, LA.
  • The objective of the clinical study is to obtain key data that will represent the performance and efficacy of Positron’s new state-of-the-art PET-CT imaging device.
  • The initial phase of the clinical study will consist of phantom testing and subsequent imaging of human patients once Positron receives its Investigational Device Exemption from the FDA.
  • In parallel with the clinical study Positron will submit its 510k and Registration to the FDA for clearance to market and sell the Affinity PET-CT.

SciSparc Announces Initiation of Randomized Phase IIb Clinical Trial of its Proprietary SCI-110 for Tourette Syndrome

Retrieved on: 
Thursday, September 7, 2023
Yale Global Tic Severity Scale, Institutional review board, Yale School of Medicine, Federal Institute for Drugs and Medical Devices, Central nervous system, Medical device, Hannover Medical School, Yale Child Study Center, Spectrum, Clinical trial, Tourette syndrome, Federal Ministry of Health (Germany), Yale school, Disorder, TS, Ministry, TEL, Patient, Tel Aviv Sourasky Medical Center, Growth, Phase, Agitation, Safety, Pharmaceutical industry

TEL AVIV, Israel, Sept. 07, 2023 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) ("Company" or "SciSparc"), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders and rare diseases of the central nervous system, today announced the initiation of its Phase IIb Clinical Trial for its proprietary SCI-110 for the treatment of Tourette Syndrome (“TS”) at the Tel Aviv Sourasky Medical Center in Israel (“Sourasky”).

Key Points: 
  • The trial is based on the positive data results received from the single arm Yale School of Medicine study using SCI-110 for TS.
  • "The initiation of our Phase IIb Clinical Trial at Sourasky, the Israeli site, is a major milestone towards commercializing our proprietary SCI-110 for TS patients.
  • TS in adults can be a debilitating disorder for which current treatments result in limited benefits.
  • The patients will be randomized at a 1:1 ratio to receive either SCI-110 or a SCI-110-matched placebo.