Competent authority

Immutep Receives Positive Feedback from the Spanish Medicines Agency for Upcoming TACTI-004 Registrational Trial in Metastatic Non-Small Cell Lung Cancer

Retrieved on: 
Wednesday, April 17, 2024
Medication, Cancer, Competence, Statistics, Regulation, CHMP, ASX, Autoimmune disease, Competent authority, AEMPS, NSCLC, IMM, Pharmaceutical industry

SYDNEY, AUSTRALIA, April 17, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces it has received positive feedback from the Spanish Agency for Medicines and Health Products (AEMPS) Competent Authority regarding the Company’s upcoming TACTI-004 Phase III trial of eftilagimod alpha (“efti”) for first line treatment of metastatic non-small cell lung cancer (1L NSCLC).

Key Points: 
  • SYDNEY, AUSTRALIA, April 17, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces it has received positive feedback from the Spanish Agency for Medicines and Health Products (AEMPS) Competent Authority regarding the Company’s upcoming TACTI-004 Phase III trial of eftilagimod alpha (“efti”) for first line treatment of metastatic non-small cell lung cancer (1L NSCLC).
  • Immutep SVP, Regulatory & Strategy, Christian Mueller commented: “We continue to be pleased with our discussions with regulatory bodies around the world regarding our upcoming pivotal TACTI-004 trial and are thankful for the positive feedback and constructive guidance received by AEMPS.
  • Among the other items discussed at the meeting were general aspects of the trial design, including selection of the control arm and statistics, and the specificities of the patient population.
  • Additional interactions with regulatory agencies as well as with other stakeholders and potential partners are ongoing in a productive manner.

ISPE Announces Health Authority Representatives from Australia, Austria, Germany, Switzerland, and the US as Featured Speakers at the 2024 ISPE Aseptic Conference

Retrieved on: 
Thursday, February 22, 2024
Competent authority, Asepsis, TGA, FDA, ISPE, US FDA, AGES, International Society, Medication, Pharmaceutical industry, Conference, Health, RP, Therapeutic Goods Administration, Patient, Knowledge

NORTH BETHESDA, Md., Feb. 22, 2024 /PRNewswire-PRWeb/ -- The International Society for Pharmaceutical Engineering (ISPE) has announced representative participation from health authorities around the world at the 2024 ISPE Aseptic Conference. Featured speakers include representatives from the Austrian Agency for Health and Food Safety (AGES/Austria), Regierungspraesidium (RP) Tübingen in Germany, Swissmedic in Switzerland, the Therapeutic Goods Administration (TGA) in Australia, and the United States Food and Drug Administration (US FDA).

Key Points: 
  • The 2024 ISPE Aseptic Conference will take place 12-13 March 2024 in Vienna, Austria, and virtually.
  • NORTH BETHESDA, Md., Feb. 22, 2024 /PRNewswire-PRWeb/ -- The International Society for Pharmaceutical Engineering ( ISPE ) has announced representative participation from health authorities around the world at the 2024 ISPE Aseptic Conference .
  • Esteemed representatives from these national regulatory agencies will discuss current issues in aseptic processing from a technical perspective.
  • "I am very honored to be one of the keynote speakers at the 2024 ISPE Aseptic Conference in Vienna.

EBA publishes findings of ad-hoc analysis on banks bonds’ holdings

Retrieved on: 
Saturday, July 29, 2023
Risk management, Risk assessment, European Banking Authority, EBA, Competent authority, European, Risk, EVE, Cryptocurrency, EU

28 July 2023

Key Points: 
  • 28 July 2023
    The European Banking Authority (EBA) today published findings of an ad-hoc analysis of unrealised losses on debt securities held at amortised cost in EU banks.
  • This targeted analysis is part of the ongoing regular risk monitoring of the EU banking sector conducted by the EBA in collaboration with Competent Authorities.
  • The ad-hoc analysis is a targeted risk assessment conducted by the EBA in collaboration with competent authorities, which aims at understanding the potential evolution of unrealised losses on EU banks’ debt securities held at amortised cost.
  • The hypothetical gains and losses calculated in this analysis should be assessed taking into account the overall interest risk management of the banks.

EBA publishes the results of its 2023 EU-wide stress test

Retrieved on: 
Saturday, July 29, 2023
Pillar, Exercise, Insurance, EEA, Unemployment, European Banking Authority, EBA, Competent authority, GDP, European, NFCI, Contract, Cryptocurrency, Pet industry, Petroleum, EU, Delta

28 July 2023

Key Points: 
  • 28 July 2023
    The European Banking Authority (EBA) today published the results of its 2023 EU-wide stress test, which involved 70 banks from 16 EU and EEA countries, covering 75% of the EU banking sector assets.
  • This stress test allows supervisors to assess the resilience of EU banks over a three-year horizon under both a baseline and an adverse scenario.
  • In terms of GDP decline, the 2023 adverse scenario is the most severe used in the EU wide stress up to now.
  • This year’s stress test includes some important enhancements compared to past stress test exercises.

The EBA consults on Guidelines on the application of the group capital test for investment firm groups

Retrieved on: 
Tuesday, July 25, 2023
ESFS, Article, European Banking Authority, Article 16, EBA, Social, Competent authority, European, Risk, Guideline, Authority, Medical device, Property management, EU

25 July 2023

Key Points: 
  • 25 July 2023
    The European Banking Authority (EBA) launched today a consultation on the draft Guidelines on the application of the group capital test for investment firm groups.
  • These Guidelines aim at setting harmonised criteria to address the observed diversity in the application of the group capital test across the EU.
  • The criteria for allowing the use of the application of the group capital test, as laid down in the Investment Firms Regulation (IFR), appear to be subject to different interpretations by supervisory authorities.
  • Accordingly, the EBA is of the view that a more harmonised application of this provision is necessary and can be achieved with these Guidelines.

The EBA is collecting institutions' data on environmental, social and governance risks to set up a monitoring system

Retrieved on: 
Friday, July 21, 2023
Pillar, Article 32 hearing, European Banking Authority, European Parliament, Infrastructure, Disclosure, Article, EBA, Decision, CRR, United Nations Security Council Resolution 24, Collection, Council, ESG, Competent authority, Letter, Medical device, EU, European

18 July 2023

Key Points: 
  • 18 July 2023
    The European Banking Authority (EBA) published today the Decision on an ad hoc data collection of institutions’ ESG data.
  • Article 18a of the Implementing Regulation (EU) 2021/637 provides for specific uniform disclosure formats and associated instructions for those disclosures.
  • Competent Authorities will need to submit institutions’ data to the EBA by June 2024.
  • The first semi-annual reference date is 30 June 2024 and data will have to be submitted by 31 December 2024.

The EBA is collecting institution’s data on environmental, social and governance risks to set up a monitoring system

Retrieved on: 
Wednesday, July 19, 2023
Pillar, Article 32 hearing, European Banking Authority, European Parliament, Infrastructure, Disclosure, Article, EBA, Decision, CRR, United Nations Security Council Resolution 24, Collection, Council, ESG, Competent authority, Letter, Medical device, EU, European

18 July 2023

Key Points: 
  • 18 July 2023
    The European Banking Authority (EBA) published today the Decision on an ad hoc data collection of institutions’ ESG data.
  • Article 18a of the Implementing Regulation (EU) 2021/637 provides for specific uniform disclosure formats and associated instructions for those disclosures.
  • Competent Authorities will need to submit institutions’ data to the EBA by June 2024.
  • The first semi-annual reference date is 30 June 2024 and data will have to be submitted by 31 December 2024.

ESMA publishes Report on Suspicious Transactions and Order Reports

Retrieved on: 
Monday, July 17, 2023
European Securities and Markets Authority, ESMA, Competent authority, Sorell, Tasmania, Time, Cryptocurrency, Drug, EEA

ESMA publishes Report on Suspicious Transactions and Order Reports

Key Points: 
  • ESMA publishes Report on Suspicious Transactions and Order Reports
    17/07/2023
    The European Securities and Markets Authority (ESMA), the EU’s financial markets regulator and supervisor, is today publishing a Report on Suspicious Transactions and Order Reports (STORs).
  • The report provides an overview of how STORs are used across different jurisdictions in the context of the detection and investigation of market abuse, and how their use has evolved over time.
  • The report covers mainly 2021 and 2022.
  • Next steps
    ESMA continues to monitor STORs and may issue an updated report next year covering 2023.

AIM ImmunoTech Announces Authorizations from Competent Authority and Ethics Board in the Netherlands to Begin a Phase 1b/2 Study Evaluating Ampligen® (rintatolimod) in Combination with AstraZeneca’s Imfinzi (durvalumab) for the Treatment of Pancreatic Can

Retrieved on: 
Tuesday, June 27, 2023
Pancreatic cancer, Response evaluation criteria in solid tumors, AIM, Therapy, IV, Competence, RECIST, DLT, Erasmus MC, Toxicity, Research, FOLFIRINOX, Erasmus, Doctor of Philosophy, AstraZeneca, Trial of the century, NYSE, Competent authority, MD, Patient, Central committee, Durvalumab, AIM ImmunoTech, Disease, Safety, Nootropic, Pharmaceutical industry, Rintatolimod

OCALA, Fla., June 27, 2023 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”), an immuno-pharma company focused on the research and development of its TLR-3 agonist Ampligen (rintatolimod) as a novel and potentially powerful therapeutic in locally advanced pancreatic cancer (“LAPC”) and metastatic pancreatic cancer, today announced the required approvals from the Netherlands for Erasmus Medical Center (“Erasmus MC”) to begin a Phase 1b/2 study under the previously announced external sponsored collaborative clinical research agreement with AstraZeneca and Erasmus MC.

Key Points: 
  • The primary objective of the Phase 1b portion of the study is to determine the safety of combination therapy with durvalumab and Ampligen.
  • The primary objective of the Phase 2 portion of the trial is to determine the clinical benefit rate of combination therapy with durvalumab and Ampligen.
  • Patients will start with Ampligen 200mg via IV infusion twice per week for a total of 6 weeks (12 doses).
  • After two doses of Ampligen, the first dose of durvalumab 1500mg via IV infusion will be introduced in week 2.

EBA updates list of institutions involved in the 2023 supervisory benchmarking exercise

Retrieved on: 
Friday, April 21, 2023
Exercise, European Banking Authority, EBA, Data collection, Benchmarking, Competent authority, European, European Economic Area, Gross metropolitan product, EU

21 April 2023

Key Points: 
  • 21 April 2023
    The European Banking Authority (EBA) published today an updated list of institutions, which have a reporting obligation for the purpose of the 2023 EU supervisory benchmarking exercise.
  • The EBA will be conducting the 2023 benchmarking exercise on a sample of 117 institutions from 16 countries across the EU and the European Economic Area.
  • The EBA runs this exercise leveraging on established data collection procedures and formats of regular supervisory reporting and assists Competent Authorities in assessing the quality of internal approaches used to calculate risk weighted exposure amounts.
  • Franca Rosa Congiu
    [email protected] | +33 1 86 52 7052 | Follow @EBA_News