Neuromuscular blocking agents

Baudax Bio Announces Corporate Update

Retrieved on: 
Wednesday, October 18, 2023
FDA, IND, Consultant, Neuromuscular blocking agents, MD, Autoantibody, Acquisition, Research, Drug development, Quality of life, Clinical trial, Haemophilia A, Factor VIII, Patient, Pharmaceutical industry, Haemophilia

MALVERN, Pa., Oct. 18, 2023 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (the “Company” or “Baudax Bio”) (NASDAQ: BXRX), a biotechnology company focused on developing T cell receptor (“TCR”) therapies utilizing human regulatory T cells (“Tregs”), as well as a portfolio of clinical stage Neuromuscular Blocking Agents (“NMBs”) and an associated reversal agent, today announced that following recent shareholder approval of corporate actions related to its June 29 2023 acquisition of TeraImmune, the Company is now poised to initiate clinical development of TI-168, the Company’s next-generation, FVIII specific Treg therapy designed to reliably and effectively address Hemophilia A patients with FVIII inhibitors. The Company anticipates initiating its Phase 1/2a clinical study of TI-168 in Hemophilia A patients with FVIII inhibitors with a modest initial budget in Q1 of 2024.

Key Points: 
  • The Company anticipates initiating its Phase 1/2a clinical study of TI-168 in Hemophilia A patients with FVIII inhibitors with a modest initial budget in Q1 of 2024.
  • “We are very pleased with the broad support received in last week’s special shareholder meeting, during which shareholders approved all remaining issues related to our acquisition of TeraImmune,” said Gerri Henwood, President and Chief Executive Officer of Baudax Bio.
  • “We believe this combination, which brings together TeraImmune’s research expertise with Baudax’s drug development experience for the initiation of clinical development of TI-168, represents the best path forward to create shareholder value.
  • This product candidate previously had an IND filed seeking to treat human subjects that received regulatory clearance, and has also recently been granted Orphan Drug Designation by the FDA.

Baudax Bio Announces Orphan Drug Designation Granted by U.S. FDA for TI-168 for the Treatment of Hemophilia A with Inhibitors

Retrieved on: 
Thursday, September 28, 2023
Drug discovery, Food and Drug Administration, Patient, Neuromuscular blocking agents, FDA, Haemophilia A, IND, Treatment, Food, Pharmaceutical industry, Haemophilia

MALVERN, Pa., Sept. 28, 2023 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (the “Company” or “Baudax Bio”) (NASDAQ: BXRX), a biotechnology company focused on developing T cell receptor (“TCR”) therapies utilizing human regulatory T cells (“Tregs”), as well as a portfolio of clinical stage Neuromuscular Blocking Agents (“NMBs”) and an associated reversal agent, today announced that U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its lead clinical candidate TI-168 for the treatment of Hemophilia A with inhibitors.

Key Points: 
  • MALVERN, Pa., Sept. 28, 2023 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (the “Company” or “Baudax Bio”) (NASDAQ: BXRX), a biotechnology company focused on developing T cell receptor (“TCR”) therapies utilizing human regulatory T cells (“Tregs”), as well as a portfolio of clinical stage Neuromuscular Blocking Agents (“NMBs”) and an associated reversal agent, today announced that U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its lead clinical candidate TI-168 for the treatment of Hemophilia A with inhibitors.
  • TI-168 is the Company’s next-generation, FVIII specific Treg therapy designed to reliably and effectively address Hemophilia A patients with FVIII inhibitors.
  • “We are very pleased with the FDA’s decision to grant orphan drug designation to TI-168, which we believe highlights the urgent need for innovation and new therapeutic options for Hemophilia A patients,” said Gerri Henwood, President and Chief Executive Officer of Baudax Bio.
  • “We believe this is an important therapeutic area, with established preclinical proof of concept in TI-168 through successes observed in Hemophilia A with inhibitors in animal models.

Baudax Bio to Participate in the H.C. Wainwright Global Investment Conference

Retrieved on: 
Thursday, September 7, 2023
Neuromuscular blocking agents, Conference, Pharmaceutical industry, Management

MALVERN, Pa., Sept. 07, 2023 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (the “Company” or “Baudax Bio”) (NASDAQ: BXRX), a biotechnology company focused on developing T cell receptor (“TCR”) therapies utilizing human regulatory T cells (“Tregs”), as well as a portfolio of clinical stage Neuromuscular Blocking Agents (“NMBs”) and an associated reversal agent, today announced that that the Company’s management will be participating in the 25th Annual H.C. Wainwright Global Investment Conference, to be held September 11-13, 2023 in New York, NY.

Key Points: 
  • MALVERN, Pa., Sept. 07, 2023 (GLOBE NEWSWIRE) -- Baudax Bio, Inc. (the “Company” or “Baudax Bio”) (NASDAQ: BXRX), a biotechnology company focused on developing T cell receptor (“TCR”) therapies utilizing human regulatory T cells (“Tregs”), as well as a portfolio of clinical stage Neuromuscular Blocking Agents (“NMBs”) and an associated reversal agent, today announced that that the Company’s management will be participating in the 25th Annual H.C. Wainwright Global Investment Conference, to be held September 11-13, 2023 in New York, NY.
  • Gerri Henwood, President & Chief Executive Officer of Baudax Bio, will give a pre-recorded presentation highlighting the Company’s cellular therapy programs, which will be available on-demand by clicking here for the duration of the conference.
  • Ms. Henwood will also be available for one-on-one meetings.

Baudax Bio Announces Distribution of Series C Preferred Stock to Holders of its Common Stock

Retrieved on: 
Wednesday, August 23, 2023
Neuromuscular blocking agents, Security (finance), Bangladesh Securities and Exchange Commission, Proxy, Series

The shares of Series C Preferred Stock will be distributed to such recipients at 5:00 p.m. Eastern Time on September 7, 2023.

Key Points: 
  • The shares of Series C Preferred Stock will be distributed to such recipients at 5:00 p.m. Eastern Time on September 7, 2023.
  • Subject to certain limitations, each outstanding share of Series C Preferred Stock will have 1,000,000 votes per share (or 1,000 votes per one one-thousandth of a share of Series C Preferred Stock).
  • The Series C Preferred Stock will be uncertificated, and no shares of Series C Preferred Stock will be transferable by any holder thereof except in connection with a transfer by such holder of any shares of the Company’s common stock held by such holder.
  • In that case, a number of one one-thousandths of a share of Series C Preferred Stock equal to the number of shares of the Company’s common stock to be transferred by such holder would be transferred to the transferee of such shares of common stock.

Baudax Bio Announces $1.9 Million Registered Direct Offering Priced At-The-Market under Nasdaq Rules

Retrieved on: 
Thursday, August 17, 2023
Exercise, A-7, A-6, Peer-to-peer file sharing, Securities and Exchange Commission (Nigeria), Sale, Prospectus, VWAP, Approval, Series, Form, Neuromuscular blocking agents, Security (finance), A-5, Adjustment

The warrants are exercisable for a period of five years commencing from the date the Approval is obtained.

Key Points: 
  • The warrants are exercisable for a period of five years commencing from the date the Approval is obtained.
  • The closing of the registered direct offering and the concurrent private placement is expected to occur on or about August 21, 2023, subject to the satisfaction of customary closing conditions.
  • The gross proceeds from the offerings, before deducting offering expenses payable by the Company, are expected to be approximately $1.9 million.
  • A final prospectus supplement and accompanying prospectus relating to the registered direct offering will be filed with the SEC.

Baudax Bio Reports Second Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, August 16, 2023
Good, ED95, Bromide, Bio, Drug discovery, Clinical trial, EMG, NMB, Research, Myasthenia gravis, Doctor of Philosophy, TI-68, Acquisition, Patent, Patient, IRB, VIII, Data, Plasma protein binding, Neuromuscular blocking agents, Intubation, FDA, Haemophilia A, IND, Three Months, Treatment, Pharmaceutical industry, Clothing, Cryptocurrency, Birth control, Haemophilia

MALVERN, Pa., Aug. 16, 2023 (GLOBE NEWSWIRE) --  Baudax Bio, Inc. (Nasdaq:BXRX) (“Baudax Bio” or the “Company”), is a biotechnology company focused on developing T cell receptor (“TCR”) therapies utilizing human regulatory T cells (“Tregs”), as well as a portfolio of clinical stage Neuromuscular Blocking Agents (“NMBs”) and an associated reversal agent, today announced results for the three and six months ended June 30, 2023 and provided a business update.

Key Points: 
  • “Our second quarter was a transformative period for Baudax Bio, during which we announced positive top-line results from our Phase 2 BX1000 trial and capped off with our acquisition of TeraImmune,” said Gerri Henwood, President and Chief Executive Officer of Baudax Bio.
  • The acquisition was unanimously approved by the Board of Directors of Baudax Bio and the Board of Directors of TeraImmune.
  • Financial Results for the Three Months Ended June 30, 2023
    As of June 30, 2023, Baudax Bio had cash and cash equivalents of $1.4 million.
  • Baudax Bio reported net loss from continuing operations of $(14.7) million, or $(4.08) per share, for the six months ended June 30, 2023.

Corium and Lotus Pharmaceutical Enter into Exclusive License Agreement for Innovative Alzheimer's Disease Treatment ADLARITY® in Multiple Markets Across Asia

Retrieved on: 
Thursday, August 10, 2023
Health, Genetics, Managed Care, Clinical Trials, Pharmaceutical, Biotechnology, Hypersensitivity, Cholinesterase, Nausea, Bethanechol, Bradycardia, Peptic ulcer disease, Asthma, Neuromuscular blocking agents, Cholinergic, Partnership, Alzheimer's disease, Diarrhea, Gastrointestinal tract, IQVIA, Roflumilast, Skin, History, Orthostatic syncope, CNS, Heart block, Dementia, Tablet, Anesthesia, Vomiting, Enzyme inhibitor, Incidence, Patient, Chloride, Gastrointestinal bleeding, Nonsteroidal anti-inflammatory drug, FDA, Relaxation, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Cholinesterase inhibitor, Safety, Food, Caregiver, Pharmaceutical industry, Residential care, Dietary supplement, Corium, Donepezil, Lotus

Corium, LLC (“Corium”), a commercial-stage biopharmaceutical company leading the development and commercialization of novel neuroscience therapies, and Lotus Pharmaceutical (1795:TT; “Lotus”), a multinational pharmaceutical company, announced that the companies have entered into an exclusive Collaboration and License Agreement for ADLARITY® (donepezil transdermal system), an innovative Alzheimer’s dementia treatment, in ten markets across Asia.

Key Points: 
  • Corium, LLC (“Corium”), a commercial-stage biopharmaceutical company leading the development and commercialization of novel neuroscience therapies, and Lotus Pharmaceutical (1795:TT; “Lotus”), a multinational pharmaceutical company, announced that the companies have entered into an exclusive Collaboration and License Agreement for ADLARITY® (donepezil transdermal system), an innovative Alzheimer’s dementia treatment, in ten markets across Asia.
  • The companies expect to file for regulatory approval in some Asian markets later this year.
  • Under the terms of the agreement, Lotus will have exclusive rights to commercialize ADLARITY® in the applicable territory and will be responsible for the regulatory approval process.
  • According to IQVIA data, the market size of donepezil in the 10 markets in the territory is USD 185 Million.

GENIXUS Announces Launch of KinetiXTM Rocuronium Bromide Injection 5mL & 10mL Ready-to-Administer Syringes

Retrieved on: 
Thursday, August 3, 2023
Medical Supplies, FDA, Hospitals, Clinical Trials, Biotechnology, Other Health, Managed Care, Health, Pharmaceutical, Hypersensitivity, Patient, Neuromuscular blocking agents, Kinetix, ECG, Rocuronium bromide, Multimedia, Chronic pain, Cosmetic, CCO, QT interval, Paralysis, Federal Food, Drug, and Cosmetic Act, Anaphylaxis, Valvular heart disease, Propofol, Hubli railway division, Nursing care plan, Relaxation, Pulmonary hypertension, Syringe, FD, Consciousness, Pfizer, Pharmaceutical industry, Nursing

View the full release here: https://www.businesswire.com/news/home/20230803139911/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230803139911/en/
    KinetiX Propofol & Rocuronium Bromide Injection RTA Syringes.
  • KinetiX Rocuronium Bromide Injection possesses several key attributes inherent in the KinetiX platform:
    GENIXUS' Chief Commercial Officer (CCO), Seth Coombs , emphasized the company's determination to accelerate the launch of Rocuronium Bromide Injection to address the ongoing, and expected worsening, of shortages in the US market.
  • If rocuronium bromide injection is administered via the same infusion line that is also used for other drugs, it is important that this infusion line is adequately flushed between administration of rocuronium bromide injection and drugs for which incompatibility with rocuronium bromide injection has been demonstrated or for which compatibility with rocuronium bromide injection has not been established.
  • Rocuronium bromide is contraindicated in patients known to have hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents.

Fresenius Kabi Launches RFID-Enabled Rocuronium Bromide Injection, its First Product Compatible with Bluesight's KitCheck System

Retrieved on: 
Tuesday, May 30, 2023
Technology, Mobile, Wireless, Packaging, Chemicals, Plastics, Health, Manufacturing, Pharmaceutical, Transport, General Health, Internet, Electronic Design Automation, Data Management, Logistics, Supply Chain Management, Medical Supplies, Hypersensitivity, Approximation error, Rocuronium bromide, Risk, Neuromuscular blocking agents, Use, Fresenius (company), Hypotension, RFID, Magnesium, RAIN, ARC, Multimedia, Inhalation, Procainamide, Certification, Paralysis, Hypertension, Suxamethonium chloride, Hospital, Patient, Chloride, Patient safety, Anaphylaxis, Intubation, Quinidine, FDA, Relaxation, Caesarean section, Medication, Lithium, Warehouse, Medical device, Pharmaceutical industry, Medical imaging, Birth control, Death

Fresenius Kabi, a leading provider of injectable medications, announced today it has launched Rocuronium Bromide Injection with advanced RFID-enabled labels in the United States.

Key Points: 
  • Fresenius Kabi, a leading provider of injectable medications, announced today it has launched Rocuronium Bromide Injection with advanced RFID-enabled labels in the United States.
  • Rocuronium Bromide Injection is part of Fresenius Kabi's +RFID™ portfolio of smart-labeled medications , designed to help enhance patient safety and support a more-efficient medication inventory process.
  • Fresenius Kabi Rocuronium Bromide Injection +RFID is available direct from the company and U.S. wholesalers in a 50 mg per 5 mL multiple dose vial.
  • This Important Safety Information does not include all the information needed to use Rocuronium Bromide Injection safely and effectively.

NeurOptics’ Neurological Pupil index™ and Automated Pupillometry Included in Latest European Guidelines for Post-Resuscitation Care

Retrieved on: 
Tuesday, December 13, 2022
Health Technology, Data Management, Technology, Practice Management, Optical, Managed Care, General Health, Medical Devices, Hospitals, Cardiology, Software, Networks, Nursing, Health, Medical Supplies, Consensus, ECC, Prognosis, Cardiopulmonary resuscitation, Subjectivity, Neurological pupil index, European Society for Medical Oncology, ILCOR, ROSC, MD, Brain, Science, Doctor of Philosophy, International Liaison Committee on Resuscitation, ICU, Cardiac arrest, Patient, Erasmus, Research, Hospital, Resuscitation, Intensive care medicine, Neurosurgery, Business, Neurology, PLR, ERC, NPI, Journal, CPR, Emergency medicine, Multimedia, European Resuscitation Council, DOI, Neuromuscular blocking agents, Pupillometry, Pupilometer, Medical device, Pharmaceutical industry

NeurOptics Neurological Pupil index (NPi) and automated pupillometry are now included in the updated 2021 European Resuscitation Council (ERC) and European Society of Intensive Care Medicine (ESICM) Guidelines for post-resuscitation care as an objective measurement supporting neurological prognosis in patients following cardiac arrest.

Key Points: 
  • NeurOptics Neurological Pupil index (NPi) and automated pupillometry are now included in the updated 2021 European Resuscitation Council (ERC) and European Society of Intensive Care Medicine (ESICM) Guidelines for post-resuscitation care as an objective measurement supporting neurological prognosis in patients following cardiac arrest.
  • The guidelines were last updated in 2015 and reflect alignment with the International Liaison Committee on Resuscitation (ILCOR) and associated member councils.
  • NeurOptics NPi Pupillometry has emerged as an important technology that provides a quantitative measurement of pupil size and reactivity, expressed as the Neurological Pupil index (NPi).
  • : Adult advanced life support: 2020 international consensus on cardiopulmonary resuscitation and emergency cardiovascular care science with treatment recommendations.