KDR

The phase 1/2 clinical trial of Bevacizumab for treatment of Ophthalmic Diseases completed

Retrieved on: 
Wednesday, July 26, 2023

This single-arm, open-label, multicentre, phase I/II study aimed to evaluate the safety and preliminary efficacy of EB12-20145P (HLX04-O) via intravitreal injection (IVT) in patients with active wet age-related macular degeneration (wAMD).

Key Points: 
  • This single-arm, open-label, multicentre, phase I/II study aimed to evaluate the safety and preliminary efficacy of EB12-20145P (HLX04-O) via intravitreal injection (IVT) in patients with active wet age-related macular degeneration (wAMD).
  • Part 2 was a single-arm, open-label, multicentre, phase II study and 20 patients (including 6 patients from part 1) were enrolled in this part.
  • As of now, the clinical trial applications of EB12-20145P (HLX04-O) had been approved in Singapore and other countries and regions.
  • EB12-20145P (HLX04-O) has the potential to be one of the first bevacizumab approved for use in ophthalmic diseases, benefiting more patients with eye diseases worldwide.

SentinelOne and KPMG Announce Alliance to Accelerate Cyber Investigations and Response

Retrieved on: 
Tuesday, January 31, 2023

SentinelOne (NYSE: S), an autonomous cybersecurity platform company, today announced an alliance with KPMG LLP , the audit, tax and advisory firm, to accelerate investigations and response to cyberattacks.

Key Points: 
  • SentinelOne (NYSE: S), an autonomous cybersecurity platform company, today announced an alliance with KPMG LLP , the audit, tax and advisory firm, to accelerate investigations and response to cyberattacks.
  • “Our customers are global in nature and find themselves rethinking cybersecurity,” said David Nides, KPMG Principal and National Cyber Threat Management Services Co-Leader.
  • “The future of cybersecurity is autonomous, and SentinelOne, coupled with the industry experience of KPMG, helps prepare enterprises for tomorrow’s threat landscape.
  • Together, KPMG cyber response services and SentinelOne Singularity XDR can help organizations gain visibility, protection, and response against advanced threats to mitigate risk.

First Patient in the US Dosed in a Global Multicentre Phase 3 Clinical Study of Bevacizumab for treatment of Ophthalmic Diseases

Retrieved on: 
Friday, February 10, 2023

Previously, the first patients in the European Union (EU) and Australia were dosed in the same global multicenter phase 3 clinical trial of EB12-20145P (HLX04-O).

Key Points: 
  • Previously, the first patients in the European Union (EU) and Australia were dosed in the same global multicenter phase 3 clinical trial of EB12-20145P (HLX04-O).
  • Meanwhile, the first patient has been dosed in a parallel phase 3 clinical trial in China for EB12-20145P (HLX04-O) for the treatment of wAMD.
  • This randomised, double-blinded, active-controlled, global phase 3 study aims to compare the efficacy and safety of EB12-20145P (HLX04-O) with ranibizumab in patients with wet age-related macular degeneration (wAMD).
  • EB12-20145P (HLX04-O) has the potential to be one of the first bevacizumab approved for use in ophthalmic diseases, benefiting more patients with eye diseases worldwide.

Konica Minolta Healthcare Transforms the Future of X-ray in Latin America

Retrieved on: 
Sunday, November 27, 2022

* Chosen by numerous healthcare facilities throughout North America, the KDR Primary and mKDR Xpress will complement Konica Minoltas existing portfolio of CR systems, DR retrofit solutions and PACS throughout the region.

Key Points: 
  • * Chosen by numerous healthcare facilities throughout North America, the KDR Primary and mKDR Xpress will complement Konica Minoltas existing portfolio of CR systems, DR retrofit solutions and PACS throughout the region.
  • As a leading provider of DR systems in North America, Konica Minolta is pleased to bring our advanced DR systems to Latin America, says Bruce Ashby, Vice President of Sales for DR Solutions at Konica Minolta Healthcare.
  • About Konica Minolta Healthcare Americas, Inc.
    Konica Minolta Healthcare is a world-class provider and market leader in medical diagnostic imaging and healthcare information technology.
  • Konica Minolta Healthcare Americas, Inc., headquartered in Wayne, NJ, is a division of Konica Minolta, Inc.For more information on Konica Minolta Healthcare Americas, Inc., follow us on LinkedIn , Twitter and Facebook , or visit https://healthcare.konicaminolta.us .

Outlook Therapeutics® Announces Acceptance of Biologics License Application by U.S. FDA for ONS-5010 as a Treatment for Wet AMD

Retrieved on: 
Friday, October 28, 2022

That product configuration does not meet the same standards we must achieve to earn FDA approval in ophthalmology.

Key Points: 
  • That product configuration does not meet the same standards we must achieve to earn FDA approval in ophthalmology.
  • If approved, ONS-5010 can replace the need to use unapproved repackaged oncologic IV bevacizumab from compounding pharmacies for the treatment of wet AMD.
  • The FDA accepted Outlook Therapeutics BLA submission for ONS-5010 to treat wet AMD with a PDUFA goal date of August 29, 2023.
  • The submission is supported by Outlook Therapeutics wet AMD clinical program, which consists of three clinical trials: NORSE ONE, NORSE TWO, and NORSE THREE.

Outlook Therapeutics® and AmerisourceBergen Announce Strategic Commercialization Agreement for ONS-5010 for the Treatment of Wet AMD

Retrieved on: 
Tuesday, September 27, 2022

Together, we believe we will be in a position to significantly upgrade treatment options for people living with wet AMD.

Key Points: 
  • Together, we believe we will be in a position to significantly upgrade treatment options for people living with wet AMD.
  • Through the agreement with AmerisourceBergen, Outlook Therapeutics expects to significantly increase market access and efficient distribution of ONS-5010, if approved by the FDA.
  • Outlook Therapeutics is also exploring a relationship with AmerisourceBergen to support the launch of ONS-5010 in international markets.
  • Outlook Therapeutics has submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010 to treat wet AMD.

Outlook Therapeutics® Re-Submits Biologics License Application for ONS-5010 as a Treatment for Wet AMD to the U.S. Food and Drug Administration

Retrieved on: 
Tuesday, August 30, 2022

In anticipation of potential FDA marketing approval in 2023, Outlook Therapeutics has continued its commercial launch planning.

Key Points: 
  • In anticipation of potential FDA marketing approval in 2023, Outlook Therapeutics has continued its commercial launch planning.
  • These activities include establishing best-in-class partnerships with FUJIFILM Diosynth Biotechnologies for drug substance, and with drug product manufacturer Ajinomoto Bio-pharma Services for finished drug product.
  • NORSE ONE was a clinical experience trial involving 61 wet AMD participants at nine trial sites in Australia.
  • Outlook Therapeutics has submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010 to treat wet AMD.

European Commission Approves Celltrion Healthcare’s Vegzelma™ (CT-P16, biosimilar bevacizumab) for the Treatment of Multiple Types of Cancer

Retrieved on: 
Friday, August 19, 2022

Celltrion Healthcare announced today that the European Commission (EC) has approved Vegzelma (CT-P16), a biosimilar bevacizumab referencing EU-approved Avastin, for the treatment of metastatic breast cancer, non-small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer and cervical cancer.

Key Points: 
  • Celltrion Healthcare announced today that the European Commission (EC) has approved Vegzelma (CT-P16), a biosimilar bevacizumab referencing EU-approved Avastin, for the treatment of metastatic breast cancer, non-small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer and cervical cancer.
  • The European Commissions approval of Vegzelma will increase access to treatment for patients living with certain types of cancer at an affordable price, said Kevin Byoung Seo Choi, Senior Vice President and Head of Marketing Division at Celltrion Healthcare.
  • The EC approval of Vegzelma follows the recommendation for marketing authorisation issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June 2022.
  • Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries.

Outlook Therapeutics Reports Financial Results for Third Quarter Fiscal Year 2022 and Reiterates Key Anticipated Near-Term Milestones

Retrieved on: 
Wednesday, August 10, 2022

Outlook Therapeutics wet AMD clinical program for ONS-5010 consists of three completed clinical trials, NORSE ONE, NORSE TWO, and NORSE THREE.

Key Points: 
  • Outlook Therapeutics wet AMD clinical program for ONS-5010 consists of three completed clinical trials, NORSE ONE, NORSE TWO, and NORSE THREE.
  • Based on a compilation of the data from these trials, Outlook Therapeutics submitted the BLA to the FDA in March 2022.
  • Outlook Therapeutics has confirmed the FDA requirements and expects to resubmit the BLA by September 2022.
  • Outlook Therapeutics cash and cash equivalents on hand are expected to provide funding into the first calendar quarter of 2023.

KSOC Launches Remediation-As-Code Response Option for Kubernetes

Retrieved on: 
Tuesday, June 21, 2022

KSOC , an event-driven SaaS platform built to automatically remediate Kubernetes security risks and enforce least privilege access control across distributed cluster infrastructures, today announced the launch of an industry-first remediation-as-code response option for its Kubernetes Detection and Response offering.

Key Points: 
  • KSOC , an event-driven SaaS platform built to automatically remediate Kubernetes security risks and enforce least privilege access control across distributed cluster infrastructures, today announced the launch of an industry-first remediation-as-code response option for its Kubernetes Detection and Response offering.
  • KSOC is the first organization in the market to offer this type of remediation response option for Kubernetes security vulnerabilities.
  • Enterprises are relying more heavily on Kubernetes, yet there is a short supply of professionals proficient in Kubernetes infrastructure.
  • To learn more about KSOC, please visit: https://www.ksoc.com/
    KSOC (Kubernetes Security Operations Center) reduces an organization's attack surface through Kubernetes Detection and Response (KDR) as well as Kubernetes Infrastructure Entitlements Management (KIEM).