Safety

New release of Philips EchoNavigator helps interventional teams treat structural heart disease with greater ease and efficiency

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Monday, May 16, 2022 - 9:00am

EchoNavigator 4.0 gives users of Philips EPIQ CVXi interventional cardiology ultrasound system greater control of live fusion-imaging on the companys Image Guided Therapy System - Azurion - platform.

Key Points: 
  • EchoNavigator 4.0 gives users of Philips EPIQ CVXi interventional cardiology ultrasound system greater control of live fusion-imaging on the companys Image Guided Therapy System - Azurion - platform.
  • By integrating real-time transesophageal echocardiography (TEE), which places the ultrasound transducer close to the heart, and X-ray fluoroscopy, EchoNavigator 4.0 helps interventional teams to decide, guide, treat, and confirm complex structural heart disease therapy, such as heart valve repair or replacement.
  • This allows us to treat our patients with greater confidence and precision during every stage of the procedure.
  • Largely due to lifestyle choices and the aging population, structural heart disease is now commonplace in older individuals.

New Data from the Open-Label PLEO-CMT-FU Trial Shows Sustained Benefit with PXT3003 in Patients with Charcot-Marie-Tooth Disease Type 1A After 5 Years of Total Trial Time

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Monday, May 16, 2022 - 7:30am

The entire CMT community is hopeful that PXT3003 could be the first approved therapy for this debilitating disease.

Key Points: 
  • The entire CMT community is hopeful that PXT3003 could be the first approved therapy for this debilitating disease.
  • All randomized CMT1A patients who completed the PLEO-CMT trial (treated with PXT3003 or placebo) were eligible to pursue treatment with PXT3003 in the PLEO-CMT-FU trial.
  • This trial enrolled a total of 187 patients and was designed to primarily assess the long-term safety and tolerability of PXT3003.
  • Patients treated with placebo in the PLEO-CMT trial were randomized in PLEO-CMT-FU to receive LD or HD of PXT3003.

New Data from the Open-Label PLEO-CMT-FU Trial Shows Sustained Benefit with PXT3003 in Patients with Charcot-Marie-Tooth Disease Type 1A After 5 Years of Total Trial Time

Retrieved on: 
Monday, May 16, 2022 - 7:30am

The entire CMT community is hopeful that PXT3003 could be the first approved therapy for this debilitating disease.

Key Points: 
  • The entire CMT community is hopeful that PXT3003 could be the first approved therapy for this debilitating disease.
  • All randomized CMT1A patients who completed the PLEO-CMT trial (treated with PXT3003 or placebo) were eligible to pursue treatment with PXT3003 in the PLEO-CMT-FU trial.
  • This trial enrolled a total of 187 patients and was designed to primarily assess the long-term safety and tolerability of PXT3003.
  • Patients treated with placebo in the PLEO-CMT trial were randomized in PLEO-CMT-FU to receive LD or HD of PXT3003.

ONE ZERO Digital Bank Chooses AU10TIX to Power its Customer Verification System and KYC (Know Your Customer) Process

Retrieved on: 
Monday, May 16, 2022 - 7:00am

TEL AVIV, Israel and NEW YORK, May 16, 2022 /PRNewswire/ -- ONE ZERO Digital Bank is proud to announce it has chosen AU10TIX to power its customer verification system and KYC (Know Your Customer) platform.

Key Points: 
  • TEL AVIV, Israel and NEW YORK, May 16, 2022 /PRNewswire/ -- ONE ZERO Digital Bank is proud to announce it has chosen AU10TIX to power its customer verification system and KYC (Know Your Customer) platform.
  • The Bank of Israel, Israel's central bank, gave ONE ZERO Digital Bank its stamp of approval to use AU10TIX's technology.
  • Amichai Levy, CTO of ONE ZERO Digital Bank, says, "The relationship between bank and customer is based on trust and security.
  • Thanks to AU10TIX, ONE ZERO Digital Bank can ensure our customers a secure means of identity verification with zero human intervention."

Mitsubishi Shipbuilding and NYK Line Obtain Approval in Principle (AiP) from Classification Society ClassNK for Large LCO2 Carrier

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Monday, May 16, 2022 - 4:41am

LCO2 carriers transport liquefied CO2 at low temperature and high pressure, which is contained in the cargo tank system.

Key Points: 
  • LCO2 carriers transport liquefied CO2 at low temperature and high pressure, which is contained in the cargo tank system.
  • MHI Group is strategically working to strengthen the energy transition business, and Mitsubishi Shipbuilding is promoting the development and commercialization of LCO2 carriers.
  • MHI believes that the grant of the AiP for a large LCO2 carrier will make a significant contribution to the realization of this strategy.
  • NYK Line believes that the establishment of CO2 transport technology by large vessels will greatly contribute to the realization of a carbon-neutral society.

Angion Announces Phase 1b Trial of ANG-3070 in Patients with Idiopathic Pulmonary Fibrosis

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Monday, May 16, 2022 - 5:05am

UNIONDALE, N.Y., May 16, 2022 (GLOBE NEWSWIRE) -- Angion Biomedica Corp. (NASDAQ:ANGN), a biopharmaceutical company focused on the discovery, development, and commercialization of novel small molecule therapeutics to address fibrotic diseases, today announced U.S. Food and Drug Administration’s (FDA) acceptance of an Investigational New Drug (IND) application supporting the clinical development of ANG-3070 in idiopathic pulmonary fibrosis (IPF) and clearance to begin a Phase 1b study of ANG-3070 in patients with IPF.

Key Points: 
  • IPF patients eligible for this Phase 1b study of ANG-3070 include those who have discontinued nintedanib or pirfenidone, refused treatment with nintedanib or pirfenidone, or those who are treatment nave.
  • Approximately 20 IPF patients will be enrolled into a crossover design trial with four arms dosing for ten days each.
  • A Phase 1b trial of ANG-3070 in patients with idiopathic pulmonary fibrosis is targeted to enroll and report data in 2022.
  • A Phase 1b trial of ANG-3070 in patients with idiopathic pulmonary fibrosis is targeted to enroll and report data in 2022.

Safr Care has completed the process to become HIPAA compliant

Retrieved on: 
Monday, May 16, 2022 - 5:00am

NEW ORLEANS, May 16, 2022 /PRNewswire-PRWeb/ -- Safr Care has completed the process to become HIPAA compliant in order to better support its expansion into non-emergency medical transportation, catering to patients who face barriers to accessibility.

Key Points: 
  • Safr Care has completed the process to become HIPAA compliant in order to better support its expansion into non-emergency medical transportation, catering to patients who face barriers to accessibility.
  • NEW ORLEANS, May 16, 2022 /PRNewswire-PRWeb/ -- Safr Care has completed the process to become HIPAA compliant in order to better support its expansion into non-emergency medical transportation, catering to patients who face barriers to accessibility.
  • "After completing The Guard's comprehensive and organization-wide Staff Compliance Training, Safr Care is proud to be awarded Compliancy Group's HIPAA Seal of Compliance," Syed Gilani, CEO of Safr, stated.
  • Safr Care's non-emergency medical transportation ensures patients attend ongoing medical care appointments, which are vital to patients' health and wellness.

Innovent Will Present Clinical Data of IBI110 (anti-LAG-3 monoclonal antibody) and Other Multiple Trials at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting

Retrieved on: 
Monday, May 16, 2022 - 1:00am

Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune, metabolic, ophthalmologyand other major diseases.

Key Points: 
  • Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune, metabolic, ophthalmologyand other major diseases.
  • On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.
  • Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities.
  • Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts.

Zenas BioPharma Submits Investigational New Drug Application in China for ZB001 for the Treatment of Thyroid Eye Disease

Retrieved on: 
Sunday, May 15, 2022 - 11:00pm

The ZB001 IND submission to the NMPA marks a significant milestone for Zenas, said Hua Mu, MD, PhD, Chief Executive Officer at Zenas.

Key Points: 
  • The ZB001 IND submission to the NMPA marks a significant milestone for Zenas, said Hua Mu, MD, PhD, Chief Executive Officer at Zenas.
  • ZB001 has the potential to change the treatment paradigm for TED patients in China.
  • ZB001 is a differentiated humanized monoclonal antibody targeting insulin-like growth factor 1 receptor (IGF-1R) for the treatment of TED.
  • For more information about Zenas BioPharma, please visit www.zenasbio.com and follow us on Twitter at @ZenasBioPharma and LinkedIn .

ROSEN, SKILLED INVESTOR COUNSEL, Encourages AbbVie Inc. Investors With Losses Over $100K to Secure Counsel Before Important Deadline in Securities Class Action – ABBV

Retrieved on: 
Sunday, May 15, 2022 - 9:00pm

WHAT TO DO NEXT: To join the AbbVie class action, go to https://rosenlegal.com/submit-form/?case_id=5119 or call Phillip Kim, Esq.

Key Points: 
  • WHAT TO DO NEXT: To join the AbbVie class action, go to https://rosenlegal.com/submit-form/?case_id=5119 or call Phillip Kim, Esq.
  • The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation.
  • Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company.
  • 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017.