European Commission

Isabel Schnabel: From laggard to leader? Closing the euro area’s technology gap

Retrieved on: 
Saturday, February 17, 2024
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This paper, by means of a DSGE model including heterogeneous firms and banks, financial frictions and prudential regulation, first shows the need of climate-related capital requirements in the existing prudential framework.

Key Points: 
  • This paper, by means of a DSGE model including heterogeneous firms and banks, financial frictions and prudential regulation, first shows the need of climate-related capital requirements in the existing prudential framework.
  • We further show that relying on microprudential regulation alone would not be enough to account for the systemic dimension of transition risk.

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.).

Fusion Pharmaceuticals Enters into Exclusive Worldwide License Agreement with Heidelberg University and Euratom for Actinium-Based PSMA Targeted Radiotherapy

Retrieved on: 
Friday, February 16, 2024

HAMILTON, ON and BOSTON, Feb. 16, 2024 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that it has entered into an exclusive worldwide license agreement with Heidelberg University and Euratom represented by the European Commission, Joint Research Centre (together, the "Licensors"). The license agreement grants Fusion exclusive worldwide rights to utilize, develop, manufacture and commercialize compounds covered by the patent, which includes 225Ac-PSMA I&T ("FPI-2265") for the treatment of prostate specific membrane antigen (PSMA)-expressing cancers. In addition, Fusion and the Licensors have signed an agreement to settle the parties' dispute related to an inter partes review ("IPR") of a U.S. patent owned by the Licensors which was instituted in August 2023 by the United States Patent and Trademark Board.

Key Points: 
  • HAMILTON, ON and BOSTON, Feb. 16, 2024 /PRNewswire/ -- Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that it has entered into an exclusive worldwide license agreement with Heidelberg University and Euratom represented by the European Commission, Joint Research Centre (together, the "Licensors").
  • The license agreement grants Fusion exclusive worldwide rights to utilize, develop, manufacture and commercialize compounds covered by the patent, which includes 225Ac-PSMA I&T ("FPI-2265") for the treatment of prostate specific membrane antigen (PSMA)-expressing cancers.
  • Fusion President and Chief Business Officer Mohit Rawat said, "We are pleased to enter into this exclusive license agreement with Heidelberg University and Euratom for their existing patent as we progress FPI-2265, the most advanced actinium-based PSMA targeted radiotherapy currently in development.
  • Under the terms of the license agreement, Fusion will pay the Licensors an aggregate upfront fee of €1.0 million, in addition to certain regulatory milestones upon potential approval and low single-digit royalties on future net sales of applicable products.

EQS-News: H2APEX: EU commission approves grant for 100 MW H2ERO hydrogen project as part of Hy2Infra-IPCEI funding

Retrieved on: 
Friday, February 16, 2024

Hy2Infra comprises 33 projects from 32 companies from seven Member States, for which the participating Member States will provide public funding of up to EUR 6.9 billion.

Key Points: 
  • Hy2Infra comprises 33 projects from 32 companies from seven Member States, for which the participating Member States will provide public funding of up to EUR 6.9 billion.
  • Among the Hy2Infra projects to be funded is the large-scale 100 MW project H2ERO by H2APEX, for which a subsidiary of H2APEX has applied for funding of approximately EUR 167 million.
  • According to current plans, the hydrogen plant will have an annual production capacity of 7,000 to 8,000 tons of green hydrogen.
  • The funding of H2ERO is a confirmation of three years of successful work on this project and reflects the leading position of H2APEX in the realization of hydrogen plants in Germany.

Fusion Fuel Receives Notification of IPCEI Approval from European Commission for 630 MW HEVO-Portugal Project

Retrieved on: 
Friday, February 16, 2024

SABUGO, Portugal, Feb. 16, 2024 (GLOBE NEWSWIRE) -- Fusion Fuel (NASDAQ: HTOO) (the “Company”) is pleased to announce that it has received notification from the European Commission that the Company’s HEVO-Portugal project was among 33 selected for approval under the Important Projects of Common European Interest (“IPCEI”) Hy2Infra program.

Key Points: 
  • SABUGO, Portugal, Feb. 16, 2024 (GLOBE NEWSWIRE) -- Fusion Fuel (NASDAQ: HTOO) (the “Company”) is pleased to announce that it has received notification from the European Commission that the Company’s HEVO-Portugal project was among 33 selected for approval under the Important Projects of Common European Interest (“IPCEI”) Hy2Infra program.
  • The €650 million, 630 MW project is to be developed in Sines, Portugal, and would produce 62,000 tonnes of green hydrogen per annum.
  • The IPCEI approval positions Fusion Fuel and its partners to commence funding negotiations with the relevant government stakeholders, as well as with the European Investment Bank, which has committed to providing financing and advisory support to those projects selected for public funding.
  • Frederico Figueira de Chaves, CEO of Fusion Fuel, stated, “This is a game changing achievement for Fusion Fuel, solidifying our position amongst the leading companies in the green hydrogen industry.

Herbal medicinal product: Echinaceae purpureae herbaArray, C: ongoing call for scientific data

Retrieved on: 
Friday, February 16, 2024

Herbal medicinal product: Echinaceae purpureae herbaArray, C: ongoing call for scientific data

Key Points: 


Herbal medicinal product: Echinaceae purpureae herbaArray, C: ongoing call for scientific data

Bee Vectoring Technologies Announces Trials in Spain with Agrobio SL and Funded by Major EU Initiative

Retrieved on: 
Thursday, February 15, 2024

Mississauga, Ontario and Sacramento, California--(Newsfile Corp. - February 15, 2024) - Bee Vectoring Technologies International Inc. (CSE: BEE) (OTCQB: BEVVF) (CVE: BEE) (the "Company" or "BVT") is pleased to announce Agrobío SL commenced trials of BVT's natural precision agriculture system in December.

Key Points: 
  • Mississauga, Ontario and Sacramento, California--(Newsfile Corp. - February 15, 2024) - Bee Vectoring Technologies International Inc. (CSE: BEE) (OTCQB: BEVVF) (CVE: BEE) (the "Company" or "BVT") is pleased to announce Agrobío SL commenced trials of BVT's natural precision agriculture system in December.
  • It will foster stakeholder adoption by surveying what they currently use, what they need, and conducting trials and demonstrations of new tools with industrial partners.
  • Spain is one of the largest fruit and vegetable producers in Europe and represents the largest market for bee vectoring in the EU.
  • Vegetable production in Spain reached about 16.39 million tons in 2021, an increase of about 1.21 million tons over 2020.

Royalty Pharma Reports Q4 and Full Year 2023 Results

Retrieved on: 
Thursday, February 15, 2024

In October 2023, Royalty Pharma drew $350 million under its existing unsecured revolving credit facility, which was repaid during the fourth quarter of 2023.

Key Points: 
  • In October 2023, Royalty Pharma drew $350 million under its existing unsecured revolving credit facility, which was repaid during the fourth quarter of 2023.
  • Royalty Pharma began repurchasing its Class A ordinary shares in April 2023 under a $1.0 billion multi-year share repurchase program.
  • During the fourth quarter of 2023, Royalty Pharma announced new transactions of up to $1.6 billion.
  • Royalty Pharma will host a conference call and simultaneous webcast to discuss its fourth quarter and full year 2023 results today at 8:00 a.m., Eastern Time.