Ethics committee

Institute for Supply Management® Partners with Kloopify to Offer Sustainability Solutions

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星期四, 五月 9, 2024
Education, Osio, Sustainability, Partnership, Ethics committee, Carbon accounting, Social responsibility, SKU, GHG, ISM, Organization, Retail

TEMPE, Ariz., May 9, 2024 /PRNewswire/ -- Institute for Supply Management® (ISM®) announces strategic alliance with Kloopify, a sustainability solution provider that provides procurement and supply chain managers the ability to measure, manage, and reduce their environmental impact without sacrificing price, quality, and delivery.

Key Points: 
  • ISM members receive a 30 percent discount on Kloopify's subscription services to improve their supply chain's sustainability performance and to operationalize sustainability.
  • Built by and for procurement and supply chain practitioners, this tool provides visibility to sustainability impact data at the transaction level and tracks the overall progress of supplier sustainability.
  • In tandem with Kloopify, these insights, along with ISM's sustainability education, can empower procurement and supply chain teams with data-driven insights and resources.
  • Kloopify was awarded the 2023 ISM Supply Chain Trailblazer Award in the Procurement Solutions Provider Impact Category at the ISM Awards Gala on April 30, 2024.

Pliant Therapeutics Provides Corporate Update and Reports First Quarter 2024 Financial Results

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星期一, 五月 6, 2024
Idiopathic pulmonary fibrosis, FVC, Investment, Hospital, Safety, Primary sclerosing cholangitis, Research, IPF, Collagen, Trial of the century, PET, Acceleration, DMD, Tumor microenvironment, PSC, European, Novartis, Week, Therapy, Vital capacity, Muscular dystrophy, Patient, TGF, Fibrosis, Cirrhosis, Integrin, Duchenne muscular dystrophy, Biomarker, Ethics committee, Massachusetts General Hospital, ELF, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., May 06, 2024 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX), a late-stage clinical biotechnology company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, today provided a corporate update and reported first quarter 2024 financial results.

Key Points: 
  • As part of the adaptive Phase 2b/3 implementation, the Phase 2b portion of BEACON-IPF was upsized from 267 patients to 360 patients.
  • Enrollment is progressing and we expect to complete enrollment of the upsized Phase 2b study expected in the first quarter of 2025.
  • The increase was due to higher operating expenses coupled with a decrease in collaboration revenues under the Novartis agreement during the quarter.
  • As of March 31, 2024, the Company had cash, cash equivalents and short-term investments of $483.9 million.

Pulse Biosciences Reports Business Updates and First Quarter 2024 Financial Results

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星期二, 五月 7, 2024
Biotechnology, Medical Devices, Health, Health Technology, Cardiology, Table, FDA, Abstract, HRS, Research, Ethics committee, Exercise, Patient, Bank statement, Hand tool, Atrial fibrillation, GAAP, Medical device

Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary CellFX® Nanosecond Pulsed Field Ablation™ (nsPFA™) technology, today announced business updates and financial results for the first quarter ended March 31, 2024.

Key Points: 
  • Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary CellFX® Nanosecond Pulsed Field Ablation™ (nsPFA™) technology, today announced business updates and financial results for the first quarter ended March 31, 2024.
  • March 2024, received FDA 510(k) clearance for use in the ablation of soft tissue in percutaneous and intraoperative surgical procedures.
  • FDA has requested clinical data in support of the regulatory filing and discussions regarding the required clinical data are underway.
  • Company has decided to change the rights offering record date from May 16, 2024 to a date in mid-June.

Autonomix Medical, Inc. Reports Third Quarter FY2024 Financial Results and Reiterates Upcoming Key Milestones

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星期三, 二月 14, 2024
Engineering, Ethics committee, Nervous system, Research, POC, AMIX, Collateral damage, Marketing, Quality of life, Pain, Calendar, Ethics, IPO, Advertising, Launch, Completeness, Patient, Clinical trial, Disease, Pancreatic cancer, Trial of the century, Ethanol, Medical imaging

THE WOODLANDS, TX, Feb. 14, 2024 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated, reported financial results yesterday for the third quarter FY2024 ended December 31, 2023 and provided a corporate update.

Key Points: 
  • “I am incredibly pleased with the progress we have made on the corporate, financial and clinical fronts in such a short period of time.
  • We are grateful for the continued support and remain focused on successfully executing on the milestones laid out ahead of us,” commented Lori Bisson, Chief Executive Officer of Autonomix.
  • Achieving “proof-of-concept” in this area could open the door to blockbuster diseases, expanding the horizons for the Company’s technology.
  • Summary of Financial Results for Q3 FY2024 Ended December 31, 2023
    For the nine months ended December 31, 2023 and 2022, the Company incurred net losses of $10.0 million and $1.3 million, respectively.

AIM ImmunoTech Receives Erasmus Medical Center Ethics Board Authorization for Phase 2 Study of Ampligen® for the Treatment of Locally Advanced Pancreatic Cancer

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星期三, 一月 24, 2024
AIM, Patient, Cancer, MD, Erasmus MC, Ethics committee, FOLFIRINOX, Safety, Ethics, Doctor of Philosophy, Clinical trial, Pancreatic cancer, Pharmaceutical industry

OCALA, Fla., Jan. 24, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that it has received authorization from the Erasmus Medical Center (“Erasmus MC”) Ethics Committee to open a European site for the ongoing Phase 2 study (“AMP-270”) of Ampligen as a therapy for locally advanced pancreatic cancer.

Key Points: 
  • OCALA, Fla., Jan. 24, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that it has received authorization from the Erasmus Medical Center (“Erasmus MC”) Ethics Committee to open a European site for the ongoing Phase 2 study (“AMP-270”) of Ampligen as a therapy for locally advanced pancreatic cancer.
  • “Approval from the governing ethics board is an important step toward enrolling subjects in the European arm of the AMP-270 clinical trial for locally advanced pancreatic cancer,” stated Prof. Casper H.J.
  • van Eijck, MD, PhD, Pancreato-biliary Surgeon at Erasmus MC in the Netherlands.
  • AMP-270 is expected to enroll approximately 90 subjects in the United States and Europe.

Arrowhead Pharmaceuticals Files for Regulatory Clearance to Initiate Phase 1/2a Study of ARO-CFB for Complement Mediated Kidney Disease

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星期四, 十二月 21, 2023
Health, Medical Devices, Other Health, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Committee, RNA, Liver, RNA interference, System, CFB, Kidney, Kidney disease, Glomerulonephritis, Translational medicine, Arrowhead Pharmaceuticals, Arrowhead, MBA, Clinical trial, Pharmacokinetics, Complement factor B, Ethics committee, Discovery, Safety, Patient, Pharmaceutical industry

Additionally, ARO-CFB may have clinical applications in non-renal diseases involving complement activation.

Key Points: 
  • Additionally, ARO-CFB may have clinical applications in non-renal diseases involving complement activation.
  • ARO-CFB is designed to reduce hepatic expression of complement factor B (CFB), which plays an important regulatory role in amplifying complement alternative pathway activation and has been identified as a promising therapeutic target.
  • James Hamilton, M.D., MBA, Chief of Discovery and Translational Medicine at Arrowhead, said: “IgAN is the most common glomerular disease worldwide, accounting for up to 40% of all cases of glomerulonephritis.
  • Pending clearance, Arrowhead intends to proceed with AROCFB-1001, a Phase 1/2a dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-CFB in up to 66 healthy volunteers and patients with complement mediated kidney disease.

Tenet Healthcare Appoints Vineeta Agarwala to Board of Directors

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星期三, 十二月 13, 2023
Managed Care, Hospitals, Health, Practice Management, Andreessen Horowitz, Biophysics, Genetics, Research, Broad Institute, NYSE, Quality, THC, Investment, Tenet Healthcare, Internal medicine, Computational biology, Doctor of Philosophy, General partnership, Intelligence, Stanford University, Ethics committee, Harvard Medical School, Drug development, Management, Tenet

Tenet Healthcare Corporation (NYSE: THC) today announced the appointment of Vineeta Agarwala, M.D., PhD, to its Board of Directors, effective immediately.

Key Points: 
  • Tenet Healthcare Corporation (NYSE: THC) today announced the appointment of Vineeta Agarwala, M.D., PhD, to its Board of Directors, effective immediately.
  • Dr. Agarwala will serve as a member of the Quality, Compliance, and Ethics Committee, as well as the Human Resources Committee, increasing the size of the Board to 13 directors.
  • “We are pleased to welcome Dr. Vineeta Agarwala to the Tenet Board,” said Saum Sutaria, M.D., Chairman and Chief Executive Officer of Tenet.
  • “Vineeta is a leader in healthcare in her own right.

Arrowhead Pharmaceuticals Files for Regulatory Clearance to Initiate Phase 1/2a Study of ARO-DM1 for Type 1 Myotonic Dystrophy

Retrieved on: 
星期二, 十一月 28, 2023
Biotechnology, Medical Devices, Health, Pharmaceutical, Clinical Trials, Life expectancy, Safety, Cataract, RNA interference, Exercise, Arrowhead, Clinical trial, DMPK, DM1, Wheelchair, Pharmacokinetics, Muscle weakness, Messenger, Therapy, Ethics committee, MBA, Committee, Wasting, Myotonia, Arrowhead Pharmaceuticals, Patient, Facial muscles, Discovery, Translational medicine, RNA, Pharmaceutical industry

Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it has filed an application for clearance to initiate a Phase 1/2a clinical trial of ARO-DM1, the company’s investigational RNA interference (RNAi) therapeutic being developed as a potential treatment for type 1 myotonic dystrophy (DM1), the most common adult-onset muscular dystrophy.

Key Points: 
  • Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it has filed an application for clearance to initiate a Phase 1/2a clinical trial of ARO-DM1, the company’s investigational RNA interference (RNAi) therapeutic being developed as a potential treatment for type 1 myotonic dystrophy (DM1), the most common adult-onset muscular dystrophy.
  • ARO-DM1 is designed to reduce expression of the dystrophia myotonica protein kinase (DMPK) gene.
  • Treatments have focused on symptomatic management, including physical therapy, exercise, ankle-foot orthoses, wheelchairs, and other assistive devices.
  • Pending clearance, Arrowhead intends to proceed with ARODM1-1001, a Phase 1/2a dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-DM1 in up to 48 subjects with DM1.

Arch Biopartners Submits Application to the Turkish Ministry of Health to Conduct a Phase II Cardiac Surgery Associated-Acute Kidney Injury Trial for LSALT Peptide

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星期五, 九月 22, 2023
Conlon, CABG, Prevalence, Science Advances, Acute kidney injury, Oxygen, MOH, OTCQB, CPB, Arch, IRI, Inflammation, Ethics committee, AKI, Dialysis, Data monitoring committee, Cardiopulmonary bypass, Ministry, Ischemia, Investigational New Drug, Patient, TMX Group, Risk, Renal replacement therapy, Disease, Kidney, Ministry of Health (Kuwait), Reperfusion, Liver, Mortality, FDA, Food, Safety, National Research Council, Pharmaceutical industry, Hospital

LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.

Key Points: 
  • LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.
  • This application in Turkey follows the Company’s submission of an Investigational New Drug Application to the U.S. Food and Drug Administration’s (FDA).
  • The FDA subsequently granted the Company permission to proceed with this Phase II trial in late June .
  • Of this total, the application to the MoH requests permission to recruit up to 150 patients in Turkey.

Charlotte's Web Reports 2023 Second Quarter Financial Results

Retrieved on: 
星期四, 八月 10, 2023
Coalition, CWEB, Sportsmen's Heritage And Recreational Enhancement Act of 2013, Congress, Natural American Spirit, Toxicology, Sport, American Legion, Press release, House, American Tobacco Company, NYSE, Interstate Commerce Committee, Nielsen Holdings, The Vitamin Shoppe, Auckland CBD, PBC, Human, Ethics committee, ACV, Hearing, TSX, Growth, FDA, IND, Safety, Legislation, LSE, Request, Energy, Millennials, Access, BTI, Charlotte's Web, Partnership, Stark Industries, Financial services, All, Clinical trial, Cannabinoid, Ethics, Premier Lacrosse League, Richard Genzer, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Pharmaceutical industry, Dietary supplement, Online shopping, CBD, Operation

Net revenue of $16.0M vs. $18.9M YoY

Key Points: 
  • Net revenue of $16.0M vs. $18.9M YoY
    LOUISVILLE, Colo., Aug. 10, 2023 /PRNewswire/ - (TSX: CWEB) (OTCQX: CWBHF), Charlotte's Web Holdings, Inc. ("Charlotte's Web" or the "Company"), the market leader in full spectrum hemp extract wellness products, today reported financial results for the second quarter ended June 30, 2023.
  • During the second quarter, the U.S. Food and Drug Administration ("FDA") committed to "work at speed" with Congress to resolve a regulatory pathway for hemp-derived CBD.
  • Recent progress has been encouraging surrounding The Hemp Derived Consumer Protection and Market Stabilization Act of 2023, (bill H.R.
  • Charlotte's Web and industry peers have compiled and shared safety and toxicology data with Congress to address concerns raised by the FDA.