Regulation of tobacco by the U.S. Food and Drug Administration

PicnicHealth Announces Three New Advisors and Expands Expertise in Regulatory-ready Research

Retrieved on: 
Monday, November 6, 2023
Software, Research, Professional Services, Pharmaceutical, Data Management, Oncology, Consumer, Technology, Data Analytics, Science, Other Consumer, Biotechnology, Health, Food, Johns Hopkins University, Public health, Life, Registry, Merck, Brody, Acquisition, Regulation of tobacco by the U.S. Food and Drug Administration, Harvard University, Professional degrees of public health, Aetion, UnitedHealth Group, University of North Carolina at Pembroke, Cerner Enviza, Faculty of Management Studies – University of Delhi, Disease, Medicine, Health policy, University, Public, Harvard T.H. Chan School of Public Health, Cancer, Center for Drug Evaluation and Research, Health policy and management, Doctor of Philosophy, IQVIA, Pharmaceutical industry, Management, Psychology, Pharmacovigilance, New York University, Epidemiology

PicnicHealth , a leading patient-centered healthcare evidence generation company, appointed three advisors in clinical research design – Nancy Dreyer, Solomon Iyasu, and Jeremy Brody.

Key Points: 
  • PicnicHealth , a leading patient-centered healthcare evidence generation company, appointed three advisors in clinical research design – Nancy Dreyer, Solomon Iyasu, and Jeremy Brody.
  • These new advisors are joining PicnicHealth in an advisory capacity to support the company’s expansion into regulatory use cases.
  • Dr. Dreyer is an internationally recognized expert in the use of real-world evidence for regulatory purposes.
  • Dr. Dreyer holds a Ph.D. in epidemiology and Master of Public Health from the University of North Carolina, Chapel Hill.

INVESTOR ALERT: Law Offices of Howard G. Smith Announces Investigation of Brainstorm Cell Therapeutics Inc. (BCLI) on Behalf of Investors

Retrieved on: 
Monday, November 6, 2023
Class Action Lawsuit, Professional Services, Legal, Suite, FDA, Telephone, ALS, News, Food, Regulation of tobacco by the U.S. Food and Drug Administration, BLA, Pharmaceutical industry

Law Offices of Howard G. Smith announces an investigation on behalf of Brainstorm Cell Therapeutics Inc. (“Brainstorm Cell” or the “Company”) (NASDAQ: BCLI ) investors concerning the Company’s possible violations of federal securities laws.

Key Points: 
  • Law Offices of Howard G. Smith announces an investigation on behalf of Brainstorm Cell Therapeutics Inc. (“Brainstorm Cell” or the “Company”) (NASDAQ: BCLI ) investors concerning the Company’s possible violations of federal securities laws.
  • On November 10, 2022, Brainstorm Cell disclosed that the U.S. Food and Drug Administration (“FDA”) had rejected its New Biologics License Application (“BLA”) for its ALS treatment, NurOwn.
  • On this news, Brainstorm Cell’s stock price fell $1.22, or 42.2%, to close at $1.67 per share on November 10, 2022, thereby injuring investors.
  • This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

ENDRA to Host Multidisciplinary Clinical Discussion on Managing Liver Disease During AASLD’s The Liver Meeting® 2023

Retrieved on: 
Monday, November 6, 2023
Health, Other Science, Clinical Trials, Research, Science, Biotechnology, Sale, Hynes Convention Center, Harvard Medical School, American Association for the Study of Liver Diseases, Food, Therapy, Hepatology, Rocky Vista University College of Osteopathic Medicine, Regulation of tobacco by the U.S. Food and Drug Administration, Doctor of Science, De novo, Ultrasound, Disease, Weill Cornell Medicine, KOL, Diabetes, NDRA, Metabolism, Patient, AASLD, Medical imaging, Radiology, Endocrinology, Medicine

ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), today announced it will host an offsite panel discussion with multidisciplinary experts during the American Association for the Study of Liver Diseases (AASLD) annual meeting, The Liver Meeting, taking place November 10-14, 2023, in Boston.

Key Points: 
  • ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), today announced it will host an offsite panel discussion with multidisciplinary experts during the American Association for the Study of Liver Diseases (AASLD) annual meeting, The Liver Meeting, taking place November 10-14, 2023, in Boston.
  • The panel will feature three key opinion leaders (KOLs) in the fields of hepatology, endocrinology and radiology sharing their unique perspectives on managing Metabolic-Associated Steatotic Liver Disease (MASLD).
  • “We are delighted to be attending the prestigious AASLD The Liver Meeting and contributing to the topical discussion of early detection and management of MASLD.
  • “With the near-term prospect of therapeutics for treating steatotic liver disease coming to market, there is a pressing clinical need for a non-invasive and cost-effective tool to screen and monitor patients,” he added.

The Law Offices of Frank R. Cruz Announces Investigation of Brainstorm Cell Therapeutics Inc. (BCLI) on Behalf of Investors

Retrieved on: 
Friday, November 3, 2023
Class Action Lawsuit, Professional Services, Legal, Suite, FDA, Food, News, Regulation of tobacco by the U.S. Food and Drug Administration, Law, ALS, BLA, Pharmaceutical industry

The Law Offices of Frank R. Cruz announces an investigation of Brainstorm Cell Therapeutics Inc. (“Brainstorm Cell” or the “Company”) (NASDAQ: BCLI ) on behalf of investors concerning the Company’s possible violations of federal securities laws.

Key Points: 
  • The Law Offices of Frank R. Cruz announces an investigation of Brainstorm Cell Therapeutics Inc. (“Brainstorm Cell” or the “Company”) (NASDAQ: BCLI ) on behalf of investors concerning the Company’s possible violations of federal securities laws.
  • On November 10, 2022, Brainstorm Cell disclosed that the U.S. Food and Drug Administration (“FDA”) had rejected its New Biologics License Application (“BLA”) for its ALS treatment, NurOwn.
  • On this news, Brainstorm Cell’s stock price fell $1.22, or 42.2%, to close at $1.67 per share on November 10, 2022, thereby injuring investors.
  • This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

Ankyra Therapeutics Announces Promising Preclinical Data on ANK-101, a Novel Anchored Immune Medicine, in Combination with Cytotoxic Chemotherapy in Head and Neck Cancer Model

Retrieved on: 
Friday, November 3, 2023
Oncology, Health, Clinical Trials, Research, Science, Biotechnology, Survival, FDA, IND, Food, Cisplatin, Head, Health Canada, Regulation of tobacco by the U.S. Food and Drug Administration, PD-1, Translational research, Senior, Aluminium, Immunotherapy, IL-12, Neoplasm, Tumor microenvironment, Society, Cancer, Therapy, Patient, Toxicity, Neck, Investigational New Drug, Pharmaceutical industry

The study was conducted jointly by Ankyra Therapeutics and the Center for Immuno-Oncology, part of the National Institute of Health’s National Cancer Institute Center for Cancer Research.

Key Points: 
  • The study was conducted jointly by Ankyra Therapeutics and the Center for Immuno-Oncology, part of the National Institute of Health’s National Cancer Institute Center for Cancer Research.
  • The findings are being presented during the Society for Immunotherapy of Cancer Annual Meeting November 1-5, 2023 in San Diego, CA.
  • “These are promising preclinical results for ANK-101, not only as a monotherapy but also in combination with chemotherapy and checkpoint inhibitors,” said Howard L. Kaufman, M.D., President and CEO of Ankyra Therapeutics.
  • “In our preclinical studies, ANK-101 increases immune activity within the tumor microenvironment, priming the tumor for greater clinical benefit from the combination of chemotherapy and PD-1 blockade.”

FDA Grants Breakthrough Device Status to Toku’s Patented Cardiovascular Risk AI (CLAiR) Platform

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Thursday, November 2, 2023
Software, Professional Services, Pharmaceutical, Optical, Venture Capital, Technology, Medical Devices, Artificial Intelligence, Cardiology, Biotechnology, Medical Supplies, FDA, Health, Stanford University, Food, Genetics, Mortality, Breakthrough, Disease, Entrepreneurship, Regulation of tobacco by the U.S. Food and Drug Administration, Multimedia, CVD, American Heart, Risk, Hypertension, Health equity, Risk assessment, Pharmacy, Eye, Blood, AI, European Journal of Preventive Cardiology, MSEE, Patient, Emory University School of Medicine, Retina, Clair, Cardiovascular disease, Medical device, Medical imaging, Pharmaceutical industry, Ophthalmology, MD

Toku, Inc., a commercial medical device company specializing in imaging technology and AI, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to its patented CLAiR technology.

Key Points: 
  • Toku, Inc., a commercial medical device company specializing in imaging technology and AI, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to its patented CLAiR technology.
  • The CLAiR platform, if cleared by the FDA, will be the first medical device in the US market that can provide affordable, point-of-care and non-invasive evaluation for risk of cardiovascular disease (CVD) using fundus retinal images through a routine eye exam.
  • Working with its partners, Toku is aiming to establish the largest network for CVD risk assessment across the US and then globally.
  • View the full release here: https://www.businesswire.com/news/home/20231102799522/en/
    Toku's AI-powered CLAiR technology uses retina scans during regular eye exams to detect cardiovascular risk non-invasively.

Geron IMerge Phase 3 Presentations at Upcoming ASH Annual Meeting Reinforce Significant Durability and Breadth of Effect of Imetelstat in Lower Risk MDS

Retrieved on: 
Thursday, November 2, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, International Prognostic Scoring System, IPSS, Survival, FDA, RUNX1, H. Lee Moffitt Cancer Center & Research Institute, VAF, Food, TP53, Thrombocytopenia, Literature, EZH2, MDS, European Medicines Agency, Regulation of tobacco by the U.S. Food and Drug Administration, Imetelstat, Society, ASXL1, SF3B1, Transfusion-dependent anemia, Geron Corporation, Risk, Abstract, TI, EMA, Corporation, LR, Anemia, ETV6, Patient, Neutropenia, Mutation, Pharmaceutical industry, Communications satellite, ASH

Four abstracts have been accepted for presentation at the 65th American Society of Hematology (ASH) Annual Meeting taking place from December 9-12 in San Diego, California and virtually.

Key Points: 
  • Four abstracts have been accepted for presentation at the 65th American Society of Hematology (ASH) Annual Meeting taking place from December 9-12 in San Diego, California and virtually.
  • “Additionally, our abstract showcasing a real-world data population level analysis of over 5,000 lower risk MDS patients adds to the significant literature suggesting a correlation between TI and improvement in survival.
  • This analysis suggests imetelstat has clinical activity in lower risk MDS patients independent of risk categories.
  • Achievement of durable TI was associated with improved survival, supporting the clinical benefit of achieving transfusion independence in lower risk MDS.

Schrödinger Reports Third Quarter 2023 Financial Results

Retrieved on: 
Wednesday, November 1, 2023
Software, Biotechnology, Pharmaceutical, Oncology, General Health, Health, Technology, Clinical Trials, United European Gastroenterology, PH, PRMT5, Trial of the century, Global health, IND, Acute myeloid leukemia, MALT1, Food, PKA, FEP, Myelodysplastic syndrome, Regulation of tobacco by the U.S. Food and Drug Administration, GAAP, Mantle cell lymphoma, Research, Bill, Ulcerative colitis, Bill & Melinda Gates Foundation, Pharmacokinetics, CDC7, Phases of clinical research, Webcast, ADMET, UEG, Safety, Overweight, Therapy, Investment, Table, Patient, Cryptocurrency, Pharmaceutical industry, Bank, EU

Schrödinger today updated its financial guidance for 2023.

Key Points: 
  • Schrödinger today updated its financial guidance for 2023.
  • The Phase 1 dose-escalation study in healthy volunteers is nearing completion, and the company expects to report data from the study in the fourth quarter of 2023.
  • Schrödinger will host a conference call to discuss its third quarter 2023 financial results on Wednesday, November 1, 2023, at 4:30 p.m.
  • Schrödinger will host its Pipeline Day in New York City on Thursday, December 14, 2023, beginning at 10:00 a.m.

Xēnix Medical Receives FDA Clearance of SOLACE™ Sacroiliac Fixation System with NANOACTIV™ Nanotechnology

Retrieved on: 
Tuesday, October 31, 2023
Nanotechnology, Surgery, Health, FDA, Medical Devices, Health Technology, Technology, Other Technology, Food, MD, University of Tennessee Medical Center, Fracture, Regulation of tobacco by the U.S. Food and Drug Administration, Multimedia, Quality of life, Surgeon, University, Immobilization, Stem cell, Consolation, Patient, Sacroiliac joint dysfunction, Navigation, Sacroiliac joint, Medical device

View the full release here: https://www.businesswire.com/news/home/20231031697414/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20231031697414/en/
    Xenix Medical SOLACE Sacroiliac Fixation System (Photo: Business Wire)
    The SOLACE Sacroiliac Fixation System consists of 3D printed, threaded implants ranging 10.5mm or 12.0mm in diameter and 30mm to 115mm in length.
  • The SOLACE Sacroiliac Fixation System is intended for sacroiliac fusion for sacroiliac joint dysfunction including degenerative sacroiliitis and sacroiliac joint disruptions; augmenting, immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion; and for fracture fixation of acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
  • The NANOACTIV implant surface demonstrates elements to be considered a nanotechnology as outlined in FDA nanotechnology guidance document.
  • The SOLACE system is the only nanotechnology sacroiliac fixation system on the market designed specifically for a lateral, oblique or posterior sacral alar iliac technique, giving surgeons complete versatility with a best-in-class technology platform.

POLARIS[AR] RECEIVES CLEARANCE FROM THE U.S. FOOD AND DRUG ADMINISTRATION FOR STELLAR KNEE

Retrieved on: 
Friday, November 3, 2023
Knee, FDA, Standard of care, Columbia University Irving Medical Center, Food, Surgeon, Orthopedic surgery, Elective surgery, University of California, Regulation of tobacco by the U.S. Food and Drug Administration, Software, Environment, Mixed reality, University, Columbia University, Algorithm, Augmented reality, Robotics, Associate, Medical device, Medical imaging

MIAMI, Nov. 3, 2023 /PRNewswire/ -- POLARISAR is pleased to announce today that their STELLAR Knee has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

Key Points: 
  • MIAMI, Nov. 3, 2023 /PRNewswire/ -- POLARISAR is pleased to announce today that their STELLAR Knee has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
  • STELLAR Knee is the first clearance for POLARISAR, a company focused on creating a new category in Mixed Reality surgical guidance.
  • The STELLAR Knee workflow is open and available to be utilized across all total knee replacement implant systems.
  • STELLAR Knee not only impacts the surgeon and the patient, but also empowers healthcare providers to change the standard of care."