EMA

EMA Webinar to Showcase the Expanding Workload Automation Solution Orchestrating Automation Across the Enterprise Fabric

Retrieved on: 
Tuesday, February 27, 2024

LAFAYETTE, Colo., Feb. 27, 2024 /PRNewswire-PRWeb/ -- Enterprise Management Associates (EMA), a leading IT and data management research and consulting firm, today announced it will host a research webinar titled "Redefining Automation Horizons: Orchestrating Multi-Cloud Landscapes." This event will feature industry experts Dan Twing, President and Chief Operating Officer at EMA, Alexandra Thurel, Associate Vice President of Product Management at HCLSoftware, and Eugene Wiehahn, Partner Solutions Architect at Amazon Web Services (AWS).

Key Points: 
  • Attendees will gain valuable insights into a solution that streamlines automation processes and leverages cutting-edge technologies to drive cloud transformation and digital innovation.
  • The webinar will delve into the complexities of managing automation in today's rapidly evolving technology landscape, with a focus on multi-cloud infrastructures.
  • Discover how cloud adoption, containerization, integrations, and SaaS are reshaping workload automation requirements and solutions, presenting new opportunities for driving digital transformation within an organization.
  • "Webinar attendees will gain valuable insights into a solution that streamlines automation processes and leverages cutting-edge technologies to drive cloud transformation and digital innovation."

U.S. Food and Drug Administration (FDA) Grants Priority Review of Epcoritamab (EPKINLY®) for Difficult-to-Treat Relapsed or Refractory Follicular Lymphoma (FL)

Retrieved on: 
Tuesday, February 27, 2024

NORTH CHICAGO, Ill., Feb. 27, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review of the supplemental Biologics License Application (sBLA) for epcoritamab-bysp, a subcutaneously administered T-cell engaging bispecific antibody for the treatment of adult relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of therapy. If approved, epcoritamab-bysp (EPKINLY®) will be the first and only subcutaneous bispecific antibody to treat adults with R/R FL after two lines of prior therapy, marking its second indication following FDA and European Medicines Agency (EMA) approval of R/R third-line diffuse large B-cell lymphoma (DLBCL) treatment.

Key Points: 
  • The FDA grants Priority Review to investigational therapies that, if approved, may offer significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications.
  • This designation shortens the review period to six months compared to 10 months for Standard Review.
  • "Together with our partner Genmab, we are committed to further advancing epcoritamab as a core lymphoma therapy."
  • Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication.

Foundational V3 Framework Extended to Incorporate Usability Validation of Sensor-Based Digital Health Technologies

Retrieved on: 
Tuesday, February 27, 2024

BOSTON, Feb. 27, 2024 /PRNewswire/ -- To support the rapid evolution of digital clinical measures, today, the Digital Health Measurement Collaborative Community (DATAcc) by the Digital Medicine Society (DiMe) released an extension of its foundational Verification, Analytical Validation, and Clinical Validation (V3). The V3+ extension adds a fourth component of "Usability Validation," incorporating the evaluation of user experience at scale. Additional resources, a supporting manuscript, and new educational material are now available to make it easy for developers to implement it as they build sensor-based digital health technologies (sDHTs).

Key Points: 
  • BOSTON, Feb. 27, 2024 /PRNewswire/ -- To support the rapid evolution of digital clinical measures, today, the Digital Health Measurement Collaborative Community ( DATAcc ) by the Digital Medicine Society ( DiMe ) released an extension of its foundational Verification, Analytical Validation, and Clinical Validation (V3).
  • The V3+ extension adds a fourth component of "Usability Validation," incorporating the evaluation of user experience at scale.
  • The three components of the original V3 framework remain unchanged; the V3+ framework is now extended to evaluate the ease of use, efficiency, and user satisfaction of sDHTs.
  • "I was proud to join DATAcc in the development of V3+ to include usability as a requirement in this framework.

Servier Receives Regulatory Filing Acceptances from FDA and EMA for Vorasidenib in the Treatment of IDH-Mutant Diffuse Glioma

Retrieved on: 
Wednesday, February 21, 2024

BOSTON and SURESNES, France, Feb. 21, 2024 /PRNewswire/ -- Servier, a global leader in oncology focused on delivering meaningful therapeutic progress for the patients it serves, today announced the FDA filing acceptance and priority review for a New Drug Application (NDA) for vorasidenib, as well as the EMA granting accelerated assessment for the vorasidenib Marketing Authorization Application (MAA). This innovative targeted therapy is an oral, selective, highly brain-penetrant dual inhibitor of mutant isocitrate dehydrogenase 1 and 2 (IDH1/2) enzymes for the treatment of IDH-mutant diffuse glioma. If approved, vorasidenib would become a first-in-class targeted therapy for patients with IDH-mutant gliomas and would mark Servier's sixth approval across IDH-mutant cancers. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of August 20, 2024, while the European Commission approval is anticipated in the second half of 2024.

Key Points: 
  • This innovative targeted therapy is an oral, selective, highly brain-penetrant dual inhibitor of mutant isocitrate dehydrogenase 1 and 2 (IDH1/2) enzymes for the treatment of IDH-mutant diffuse glioma.
  • If approved, vorasidenib would become a first-in-class targeted therapy for patients with IDH-mutant gliomas and would mark Servier's sixth approval across IDH-mutant cancers.
  • "In the realm of glioma treatment, innovation has been stagnant for nearly a quarter-century, posing challenges for patients who, post-surgery, may opt to defer treatment due to concerns around potential toxic side effects.
  • "This promising outcome brings hope to patients grappling with IDH-mutant diffuse gliomas, offering a potential breakthrough for those eagerly awaiting a new therapeutic option."

Avidity Biosciences Receives FDA Rare Pediatric Disease Designation for AOC 1044 for Treatment of Duchenne Muscular Dystrophy in People with Mutations Amenable to Exon 44 Skipping

Retrieved on: 
Tuesday, February 20, 2024

In addition to receiving Rare Pediatric Disease Designation, AOC 1044 has been granted Orphan Designation by the FDA and the European Medicines Agency (EMA), and Fast Track Designation by the FDA.

Key Points: 
  • In addition to receiving Rare Pediatric Disease Designation, AOC 1044 has been granted Orphan Designation by the FDA and the European Medicines Agency (EMA), and Fast Track Designation by the FDA.
  • "We are pleased that the FDA has granted Rare Pediatric Disease designation to AOC 1044, adding to the Orphan Drug and Fast Track designations already granted.
  • Avidity plans to provide a first look at AOC 1044 data in people living with DMD44 in 2H 2024.
  • The EXPLORE44 trial is a randomized, placebo-controlled, double-blind, Phase 1/2 clinical trial to evaluate AOC 1044 in healthy volunteers and participants with DMD mutations amenable to exon 44 skipping (DMD44).

Procedural advice to applicants/marketing authorisation holders on re-examination of CVMP opinions (according to Regulation (EU) 2019/6)

Retrieved on: 
Friday, February 16, 2024

6 February 2024

Key Points: 
    • 6 February 2024
      EMA/CVMP/321528/2017 ? Rev.3
      Committee for Veterinary Medicinal Products (CVMP)

      Procedural advice to applicants/marketing authorisation
      holders on re-examination of CVMP opinions

      Table of contents
      1.

    • Assessment of the applicant?s/marketing authorisation holder?s detailed grounds for reexamination of the CVMP opinion ................................................................................ 5
      4.4.1.
    • Timetable for re-examination of opinions for work-sharing procedures, variations
      requiring assessment, referrals and establishment of maximum residue limits ................... 7
      4.4.3.
    • This document describes the procedure and gives guidance for the re-examination of
      different types of opinions of the Committee for Veterinary Medicinal Products (CVMP).
    • The conclusions reached and the reasons for those conclusions shall be annexed to its
      opinion and shall form an integral part thereof.
    • Within 15 days of the re-examination of its opinion, the Agency shall forward its opinion to the
      Commission and the applicant.
    • The re-examination procedure is not applicable for CVMP opinions on procedures according to
      Articles 54(8), 130(4), 141(1)(c) or (e) of Regulation (EU) 2019/6 as this is not foreseen in the
      legislation.
    • Applicant?s/marketing authorisation holder?s request for reexamination
      Within 15 calendar days of receipt of the CVMP opinion (date of receipt by applicant/MAH as
      documented by Eudralink), the applicant/MAH may request a re-examination of the CVMP opinion.
    • For further
      details see CVMP rules on appointment and responsibilities of the CVMP rapporteur and co-rapporteur
      in accordance with Article 140(6) of Regulation (EU) 2019/6, and peer reviewer.
    • Day 80
      Day 90

      Adoption of final CVMP opinion and assessment report (following an oral
      explanation by applicant to the CVMP, if applicable).

    • Day 50
      Day 60

      Adoption of final CVMP opinion and assessment report (following an oral
      explanation by applicant/MAH to the CVMP, if applicable).

    • Oral explanation at CVMP meeting
      The applicant/MAH has the right to be heard by the CVMP in an oral explanation.
    • CVMP final opinion on re-examination
      The procedure for adoption of the final CVMP opinion at the CVMP meeting follows the principles
      described in the CVMP rules of procedure.
    • Information to be made available to the public
      The start of a re-examination procedure will be mentioned in the CVMP meeting highlights.
    • summary of opinion, EPAR,
      refusal EPAR, questions and answers on referrals, all annexes of the CVMP opinion, etc.).

Launch of new HMA-EMA catalogues of real-world data sources and studies

Retrieved on: 
Friday, February 16, 2024

- The catalogue for RWD studies expands and replaces the European Union electronic register of post-authorisationstudies (EU PAS Register®).

Key Points: 
  • - The catalogue for RWD studies expands and replaces the European Union electronic register of post-authorisationstudies (EU PAS Register®).
  • Using ‘FAIR’ data principles (Findable, Accessible, Interoperable and Reusable), they use an agreed set of metadata to describe and connect data sources to studies.
  • In addition, search on a wider set of metadata, enhanced view, export and data submission functionalities have been implemented in the catalogues.
  • Notes
    EMA will host a webinar on the catalogues on 4 March 2024 from 10:00 to 12:00 CET.

Duke Energy supports fellow first responders with more than $200,000 in grants for emergency preparedness in Indiana

Retrieved on: 
Thursday, February 15, 2024

PLAINFIELD, Ind., Feb. 15, 2024 /PRNewswire/ -- First responders across Indiana, including local police, fire and emergency management agencies (EMAs), will benefit from more than $200,000 in grants from the Duke Energy Foundation.

Key Points: 
  • PLAINFIELD, Ind., Feb. 15, 2024 /PRNewswire/ -- First responders across Indiana, including local police, fire and emergency management agencies (EMAs), will benefit from more than $200,000 in grants from the Duke Energy Foundation.
  • "When severe weather strikes, we rely on strong partnerships with local emergency management and law enforcement agencies to effectively respond and restore power in affected communities," said Stan Pinegar, president of Duke Energy Indiana.
  • "These grants will help give first responders the tools and training they need to respond to any emergency."
  • The Foundation contributes more than $2 million annually in charitable gifts to Indiana and is funded by Duke Energy shareholder dollars.

EMA Webinar to Unveil Network Operations Toolset Strategies for the Post-Cisco Prime Era

Retrieved on: 
Thursday, February 15, 2024

LAFAYETTE, Colo., Feb. 15, 2024 /PRNewswire-PRWeb/ -- Enterprise Management Associates (EMA), a leading IT and data management research and consulting firm, today announced it will host a research webinar titled "Expert Insights: Rethinking Your Network Operations Toolset as Cisco Prime End of Life Arrives." Featuring industry experts Shamus McGillicuddy, vice president of research covering network management at EMA, and Jon Kies, team leader of ITOM cloud product marketing at OpenText, this webinar will provide essential insights for organizations navigating the transition away from Cisco Prime Infrastructure.

Key Points: 
  • For over a decade, Cisco Prime Infrastructure was a leading solution for managing, monitoring, and troubleshooting Cisco-based networks.
  • With Cisco announcing end-of-life plans for this solution and promoting migration to DNA Center (DNAC), EMA research underscores the need for organizations with multi-vendor networks to reevaluate their network operations toolset comprehensively.
  • Research from EMA discovered that the typical network operations teams use four to 15 tools to manage and monitor infrastructure.
  • Network operations teams struggle with fragmented toolsets, data quality and authority challenges, and complexity brought on by multi-vendor networks.

CEL-SCI Corporation Reports First Quarter Fiscal 2024 Financial Results

Retrieved on: 
Thursday, February 15, 2024

CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended December 31, 2023, as well as key recent clinical and corporate developments.

Key Points: 
  • CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended December 31, 2023, as well as key recent clinical and corporate developments.
  • In October 2023, the new data were presented at the 2023 European Society for Medical Oncology (ESMO) Congress.
  • CEL-SCI plans to submit the target population data to the U.S. Food and Drug Administration (FDA) this quarter.
  • CEL-SCI raised $5 million in November 2023 and $7.75 million in February 2024, both through public offerings of common stock.