Institutional review board

AHN team performs region's first deep brain stimulation therapy to treat opioid addiction

Retrieved on: 
Saturday, January 13, 2024
AHN, Death, Obesity, Learning, Drug, Patient, Addiction, Research, DBS, Electrode, Multimedia, DSM-IV codes, Accident, Fentanyl, COVID, Xylazine, Parkinson's disease, IRB, Heroin, Deep brain stimulation, Food, AGH, Allegheny Health Network, Myenteric plexus, FDA, Opioid, Nucleus accumbens, Public, Addiction medicine, Institutional review board, Brain, Trial of the century, Physician, Pharmaceutical industry

PITTSBURGH, Jan. 13, 2024 /PRNewswire-PRWeb/ -- A multidisciplinary team of physicians at Allegheny Health Network (AHN) is among the first in the nation to safely utilize deep brain stimulation therapy (DBS) to treat a patient suffering from opioid addiction.

Key Points: 
  • PITTSBURGH, Jan. 13, 2024 /PRNewswire-PRWeb/ -- A multidisciplinary team of physicians at Allegheny Health Network (AHN) is among the first in the nation to safely utilize deep brain stimulation therapy (DBS) to treat a patient suffering from opioid addiction.
  • Led by principal investigator and AHN neurosurgeon Nestor D. Tomycz, MD, the AHN team announced this week that they have successfully implanted an deep brain stimulation (DBS) device in the brain of a 28-year-old New York man with treatment-resistant opioid addiction.
  • The procedure took place in December at AHN's Allegheny General Hospital, and the patient's ongoing therapy is part of an FDA-approved clinical study.
  • DBS for opioid-use disorder involves implanting bilateral electrode leads into an area of the brain called the nucleus accumbens – the brain's addiction and reward center.

Sabai Completes Acquisition of Alpha IRB

Retrieved on: 
Wednesday, January 10, 2024
ChromeOS, Patient, Research, Culture, Partnership, Science, Alpha, Infection, IRB, Acquisition, Organization, Institutional review board, Growth, Pharmaceutical industry

ST. LOUIS, Jan. 10, 2024 /PRNewswire/ -- Sabai Group LLC ("Sabai"), a provider of custom solutions for biosafety and human research protections, today announced the acquisition of Alpha Independent Review Board, LLC ("Alpha IRB").

Key Points: 
  • ST. LOUIS, Jan. 10, 2024 /PRNewswire/ -- Sabai Group LLC ("Sabai"), a provider of custom solutions for biosafety and human research protections, today announced the acquisition of Alpha Independent Review Board, LLC ("Alpha IRB").
  • Headquartered in San Clemente, CA, Alpha IRB provides Institutional Review Board ("IRB") services for biopharma sponsors, CROs, and site networks conducting clinical trials.
  • Sabai's acquisition of Alpha IRB marks a significant milestone in the growth and expansion of both companies.
  • "Joining Sabai is a great result for patients as well as our clients and employees," said Marianne Thornton, founder of Alpha IRB.

RetinalGeniX™ Technologies Inc. Contracts With MEDsan, Inc. to Provide Diagnostic Testing Services for Its Institutional Review Board to Conduct a Study to Personalize Medical Evaluations for Patients Receiving Treatment for Wet Macular Degeneration

Retrieved on: 
Tuesday, December 26, 2023
Vance DeGeneres, Pupil, Physician, AMD, Trial of the century, MD, IRB, OTCQB, Doctor of Philosophy, Institutional review board, Patient, Paratriathlon, Diabetes, Pharmaceutical industry

“We are pleased to extend our services into testing for wet macular degeneration, a field that we have been looking at for quite some time.

Key Points: 
  • “We are pleased to extend our services into testing for wet macular degeneration, a field that we have been looking at for quite some time.
  • RetinalGeniX has also filed two provisional patents related to these studies and formed an institutional review board to launch a 390-patient clinical study intended to validate the relative suitability of anti-VEGF ocular injection treatments for patient candidates with wet AMD.
  • Jerry Katzman, MD, Chairman, President and CEO of RetinalGeniX said “MEDsan is a next-generation diagnostic CLIA-approved laboratory services facility equipped with the most technically advanced diagnostic equipment in the pharmaco-genetic space.
  • Dr. Jonathan Brenner, Ph.D., and his team are specialists running diagnostic panels and dovetails RetinalGeniX’s clinical agenda to clinical study requirements.

Myriad Genetics Establishes Comprehensive Pan-Cancer Research Platform to Advance Patient Care

Retrieved on: 
Wednesday, December 20, 2023
Myriad, HRD, Medicine, MYGN, Research, Fox Chase Cancer Center, MSI, Health, IRB, Genetics, Cancer, DNAnexus, TMB, Myriad Genetics, Institutional review board, Genetic testing, Patient, Microsatellite instability, MCRR, Pharmaceutical industry

SALT LAKE CITY, Dec. 20, 2023 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, today announced the launch of the Myriad Collaborative Research Registry ™ (MCRR).

Key Points: 
  • SALT LAKE CITY, Dec. 20, 2023 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, today announced the launch of the Myriad Collaborative Research Registry ™ (MCRR).
  • The latest enhancements make the MCRR one of the largest pan-cancer registries freely available for research use and supports transparent clinical data sharing to advance the field.
  • Built on DNAnexus, a leading enterprise Precision Health platform, the MCRR provides a secure and easy-to-use interface for scientific data analysis, collaboration, and discovery.
  • Myriad is accepting research concept forms from individuals and institutions seeking to undertake research projects.

ASLAN Pharmaceuticals Provides Year-End Update on Its Eblasakimab and Farudodstat Programs

Retrieved on: 
Tuesday, December 12, 2023
Liver, Atopic dermatitis, Eosinophilic bronchitis, Partnership, Dermatology, ASLN, Alopecia areata, Hair loss, Disease, MD, SAN, JAK, Beacon Grand Hotel, IGA, EASI, Institutional review board, TREK, DHODH, Patient, Safety, AA, Skin

SAN MATEO, Calif. and SINGAPORE, Dec. 12, 2023 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals Ltd. (Nasdaq: ASLN), a clinical-stage, immunology focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today provided a business update and updates related to its programs, eblasakimab and farudodstat.

Key Points: 
  • SAN MATEO, Calif. and SINGAPORE, Dec. 12, 2023 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals Ltd. (Nasdaq: ASLN), a clinical-stage, immunology focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today provided a business update and updates related to its programs, eblasakimab and farudodstat.
  • “Throughout 2023, ASLAN made major progress on multiple fronts – advancing both of our lead programs, eblasakimab and farudodstat in Phase 2 testing, and establishing business development collaborations to further the development and utilization of eblasakimab,” said Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals.
  • ASLAN will provide an update in early 2024 on the timing of the expected topline readout from the study in 2024.
  • Publication and presentation of further data from the TREK-AD study of eblasakimab, including biomarker data, and on farudodstat at major congresses.

Aurora Spine Corporation Announces Newly Published Paper on First 6-month Clinical Evaluation of its ZIP™ Fusion Implant

Retrieved on: 
Monday, December 4, 2023
ASG, Walking, Principal investigator, Neurosurgery, Physician, ODI, Buttocks, FDA, Pain, Decompression, Chronic pain, Spinal cord, Visual analogue scale, IRB, Low back pain, Trial of the century, Groin, PROMIS, PGIC, Institutional review board, Back pain, ZIP, Human, Patient, Safety, Journal, Leg, Spinal stenosis, Degenerative disc disease, Oswestry Disability Index, Birth control

This 6-month interim analysis at 42% enrollment of patients was conducted to determine prolonged safety and efficacy of the ZIP interspinous fusion device.

Key Points: 
  • This 6-month interim analysis at 42% enrollment of patients was conducted to determine prolonged safety and efficacy of the ZIP interspinous fusion device.
  • Dr. Sebastian Koga, a neurosurgeon from Covington, LA emphasized, “Our study demonstrates that the ZIP device provides a stable platform for posterior fusion.
  • I am happy to contribute objective clinical evidence to this area of spine surgery.
  • A previously published retrospective study has also demonstrated the ZIP device’s safety and effectiveness in the hands of interventional pain physicians.

Else Nutrition Reports Third Quarter 2023 Financial Results and Provides Fourth Quarter Outlook

Retrieved on: 
Tuesday, November 14, 2023
Giant, Institutional review board, Interest, Infant, Safety, IRB, Bank statement, Supermarket, Risk, CAD, FDA, Danone, The Giant Company, Eastern Time Zone, SEDAR, MD, Trial of the century, Geography, Loblaws, CVS, Growth, Parent, Shoppers Drug Mart, Walmart, BABY, Video game, Rare-earth element, Retail, Online shopping, Grocery store, Renewable energy, Dietary supplement, Pharmaceutical industry, Amazon

VANCOUVER, British Columbia, Nov. 14, 2023 (GLOBE NEWSWIRE) -- ELSE NUTRITION HOLDINGS INC (BABY) (BABYF) (0YL.F) ("Else" or the "Company") the Plant-Based baby, toddler, and children nutrition company, today reported its third quarter 2023 financial results for the period ending September 30, 2023. The financial statements and MD&A are available on SEDAR under the Company’s profile.

Key Points: 
  • Revenue outlook in the range of $2.7 million to $3.0 million for the fourth quarter of 2023, representing growth of 58-75% compared to the third quarter of 2023.
  • Sales to brick-and-mortar retailers in the US and Canada during the third quarter increased by 8%, compared to the third quarter of 2022.
  • Cash position as of September 30, 2023, was $4.2 million CAD, including restricted cash and short-term bank deposits.
  • The Company will host a conference call to discuss the quarter's financial results today at 10:00 a.m. Eastern Time.

First Human Clinical Study to Assess U.S. Department of Defense DNA Vaccine Candidate against Venezuelan Equine Encephalitis Delivered with PharmaJet Precision Delivery Systems.

Retrieved on: 
Thursday, November 16, 2023
Medical Devices, Medical Supplies, Homeland Security, Public Policy, Government, Clinical Trials, Biotechnology, White House, Federal Government, Health, Pharmaceutical, Stratis, ID, Institutional review board, MCDC, VEE, DNA, IRB, Alphavirus, Clinical trial, Mortality, Epidemic, DTRA, FDA, Venezuelan equine encephalitis virus, NHP, USAMRIID, Use, Injection, Unitary state, Infection, Vaccine

The Phase 1 study, sponsored by PharmaJet, aims to identify the optimal dose, vaccination schedule and delivery system most suitable for use in subsequent broader clinical evaluations of the VEE DNA vaccine candidate.

Key Points: 
  • The Phase 1 study, sponsored by PharmaJet, aims to identify the optimal dose, vaccination schedule and delivery system most suitable for use in subsequent broader clinical evaluations of the VEE DNA vaccine candidate.
  • The VEE DNA vaccine candidate is being evaluated as part of a multi-year agreement between PharmaJet and the Joint Science and Technology Office of the U.S. Defense Threat Reduction Agency (DTRA) .
  • The study, in collaboration with USAMRIID, aims to further advance the clinical assessment of the vaccine with the PharmaJet Precision Delivery Systems: Tropis Intradermal (ID) and Stratis Intramuscular (IM).
  • The PharmaJet Precision Delivery Systems are optimized for field use and have also shown immunogenicity levels higher than with needle-syringe.

Particles for Humanity Receives Approval to Begin a Study of PFH-VAP in Humans

Retrieved on: 
Tuesday, December 12, 2023
Vitamin A, Institutional review board, Research, IRB, Mineral, Mulago Foundation, Pregnancy, Principal investigator, University of Wisconsin–Madison, Bill, Multimedia, Malnutrition, Vitamin A deficiency, Humanity, Vitamin, University, Human, Tropical disease, Dietary supplement

The study is designed to confirm that PFH-VAP's improved stability enables more vitamin A to be delivered into the human body after consumption.

Key Points: 
  • The study is designed to confirm that PFH-VAP's improved stability enables more vitamin A to be delivered into the human body after consumption.
  • Particles for Humanity has partnered with the University of Wisconsin-Madison and the Tropical Diseases Research Centre in Zambia to conduct the study as part of its effort to combat vitamin A deficiency (VAD).
  • VAD is a devastating public health problem affecting 190 million children and 19 million pregnant women worldwide.
  • Particles for Humanity transforms early-stage medical technology into products for people living in low and lower-middle income countries.

WCG Revolutionizes Ethical Review Process with IRB+ Service, Achieving Unprecedented Efficiency Gains

Retrieved on: 
Thursday, November 30, 2023
IRB, Institutional review board, Clinical trial, Research, Safety, IBC, ChromeOS, WCG, Pharmaceutical industry

Mark McDonald, president, WCG Review Solutions, expressed his enthusiasm for the launch, "IRB+ represents a significant leap forward in our commitment to advancing the efficiency and quality of clinical trial processes.

Key Points: 
  • Mark McDonald, president, WCG Review Solutions, expressed his enthusiasm for the launch, "IRB+ represents a significant leap forward in our commitment to advancing the efficiency and quality of clinical trial processes.
  • We've taken a bold step in addressing the critical need for accelerated review processing without compromising the high standards of ethical oversight.
  • "IRB+ provides a tailored solution for those looking to optimize their study timelines without compromising the quality or integrity of the ethical review.
  • WCG's IRB+ marks a new era in clinical trial efficiency, combining cutting-edge technology, dedicated expertise, and a commitment to ethical oversight and participant safety.