European

IDnow joins consortium aimed at making crypto assets compliant with new EU regulations

Retrieved on: 
Tuesday, February 13, 2024

MUNICH, Feb. 13, 2024 /PRNewswire/ --  IDnow, a leading identity verification platform provider in Europe, joins a consortium of five partners including the IOTA Foundation, walt.id, SPYCE.5, and Bloom Labs with the goal of making Crypto Asset Service Providers (CASPs) and self-hosted wallets compliant with the European Anti-Money-Laundering Regulation and the Transfer of Funds Regulation (TFR). 

Key Points: 
  • Additionally, the new AML Regulation will require all CASPs to comply with similar AML rules as other financial institutions.
  • However, to comply with the new regulations, CASPs need to know with whom they are doing business and continuously verify this information.
  • "We are excited to be part of this forward-thinking consortium alongside highly esteemed crypto asset industry players to address a pressing need for crypto wallet solutions that comply with the latest EU regulations.
  • "We're proud to be part of this groundbreaking consortium, leveraging SPYCE.5's hybrid chain architecture to navigate the complex landscape of EU regulations.

EQS-News: Abivax announces presentation of four abstracts for obefazimod in ulcerative colitis and sponsorship of scientific symposium at the 19th Congress of European Crohn’s and Colitis Organization (ECCO)

Retrieved on: 
Tuesday, February 13, 2024

“We are delighted that all four submitted abstracts have been accepted for presentations at ECCO.

Key Points: 
  • “We are delighted that all four submitted abstracts have been accepted for presentations at ECCO.
  • We look forward to scientific exchange with the IBD community at ECCO,” said Sheldon Sloan, M.D., M. Bioethics, Chief Medical Officer of Abivax.
  • (Germany), on February 23, 2024, at 7:15-8:15 a.m. CET in room A12.
  • The Symposium will be broadcasted live and is accessible publicly here .

European Commission Approves First CRISPR/Cas9 Gene-Edited Therapy, CASGEVY™ (exagamglogene autotemcel), for the Treatment of Sickle Cell Disease (SCD) and Transfusion-Dependent Beta Thalassemia (TDT)

Retrieved on: 
Tuesday, February 13, 2024

ZUG, Switzerland and BOSTON, Feb. 13, 2024 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, announced today that the European Commission has granted conditional marketing authorization to CASGEVY™ (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene edited therapy. CASGEVY is approved for the treatment of patients who are 12 years of age and older with severe sickle cell disease (SCD) characterized by recurrent vaso-occlusive crises (VOCs) or transfusion-dependent beta thalassemia (TDT), for whom hematopoietic stem cell (HSC) transplantation is appropriate and a human leukocyte antigen matched related HSC donor is not available.

Key Points: 
  • “The approval by the European Commission is yet another important regulatory milestone underscoring the potentially transformative benefit of CASGEVY for patients with severe sickle cell disease and transfusion-dependent beta thalassemia,” said Samarth Kulkarni, Chairman and Chief Executive Officer of CRISPR Therapeutics.
  • Vertex is working closely with national health authorities in the European Union (EU) to secure access for eligible patients as quickly as possible.
  • Through this work, they have secured early access for eligible TDT patients in France ahead of the national reimbursement process.
  • There are currently three activated ATCs in the EU with plans to activate a total of approximately 25 centers across Europe.

European Commission Approves First CRISPR/Cas9 Gene-Edited Therapy, CASGEVY™ (exagamglogene autotemcel), for the Treatment of Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia

Retrieved on: 
Tuesday, February 13, 2024

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the European Commission has granted conditional marketing authorization to CASGEVY™ (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene-edited therapy.

Key Points: 
  • Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the European Commission has granted conditional marketing authorization to CASGEVY™ (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene-edited therapy.
  • CASGEVY is the only genetic therapy approved for SCD and TDT patients in the European Union (EU) and with this approval, there are now more than 8,000 patients potentially eligible for treatment.
  • Through this work, Vertex has secured early access for eligible TDT patients in France ahead of the national reimbursement process.
  • Vertex continues to engage with hospitals experienced in stem cell transplantation to establish a network of independently operated authorized treatment centers (ATCs) for the administration of CASGEVY.

The EBA publishes follow-up on the Peer Review on the Joint ESAs Guidelines on the prudential assessment of the acquisition of qualifying holdings

Retrieved on: 
Tuesday, February 13, 2024

The EBA publishes follow-up on the Peer Review on the Joint ESAs Guidelines on the prudential assessment of the acquisition of qualifying holdings

Key Points: 
  • The EBA publishes follow-up on the Peer Review on the Joint ESAs Guidelines on the prudential assessment of the acquisition of qualifying holdings
    The European Banking Authority (EBA) today published a follow-up to the EBA 2021 peer review report on the application of the Joint ESAs Guidelines on the prudential assessment of the acquisition of qualifying holdings.
  • The follow-up report focuses on the 17 competent authorities assessed as having at least one supervisory benchmark which was not ‘fully applied’ in the 2021 Report.
  • All 17 CAs were found to have responded to the assessment of the initial peer review seriously and most have adopted measures to remedy the deficiencies identified.
  • The peer review has been performed by an ad hoc Peer Review Committee made up of EBA and competent authorities’ staff in accordance with the EBA peer review work plan for 2023-2024 and following the process in Article 30 of the EBA Regulation and EBA peer review methodology.

Astrotech Reports Second Quarter Of Fiscal Year 2024 Financial Results

Retrieved on: 
Monday, February 12, 2024

AUSTIN, Texas, Feb. 12, 2024 (GLOBE NEWSWIRE) -- Astrotech Corporation (Nasdaq: ASTC) (the “Company” or “Astrotech”) reported its financial results for the second quarter of fiscal year 2024, which ended December 31, 2023.

Key Points: 
  • AUSTIN, Texas, Feb. 12, 2024 (GLOBE NEWSWIRE) -- Astrotech Corporation (Nasdaq: ASTC) (the “Company” or “Astrotech”) reported its financial results for the second quarter of fiscal year 2024, which ended December 31, 2023.
  • Year-to-date fiscal year 2024 gross margin increased to 46% from 38% during the comparative period in the prior year, as we continue to benefit from the further refining and ruggedizing of our equipment.
  • After the end of the quarter, 1st Detect reentered detection and non-detection testing with the U.S. Transportation Security Administration (TSA) for cargo security.
  • We exhibited it at this year’s MJ BizCon held late in the second quarter of fiscal year 2024.

Biogen Received European Commission Approval for SKYCLARYS® (omaveloxolone), the First Therapy to Treat Friedreich’s Ataxia

Retrieved on: 
Monday, February 12, 2024

“Friedreich’s ataxia patients treated with SKYCLARYS in the clinical trial experienced important and clinically meaningful improvements for their daily lives.

Key Points: 
  • “Friedreich’s ataxia patients treated with SKYCLARYS in the clinical trial experienced important and clinically meaningful improvements for their daily lives.
  • At the end of the 48-week study, patients who received SKYCLARYS had significantly improved modified Friedreich Ataxia Rating Scale (mFARS) scores relative to placebo.
  • Biogen is committed to working closely with all stakeholders to ensure that eligible European patients can have access to this treatment.
  • SKYCLARYS is also approved for use in the United States, and Biogen is engaging with regulatory authorities in other regions.

Macquarie/First Trust Global Infrastructure/Utilities Dividend & Income Fund Declares its Quarterly Distribution of $0.20 Per Share

Retrieved on: 
Monday, February 12, 2024

Macquarie/First Trust Global Infrastructure/Utilities Dividend & Income Fund (the "Fund") (NYSE: MFD) has declared the Fund's regularly scheduled quarterly distribution of $0.20 per share.

Key Points: 
  • Macquarie/First Trust Global Infrastructure/Utilities Dividend & Income Fund (the "Fund") (NYSE: MFD) has declared the Fund's regularly scheduled quarterly distribution of $0.20 per share.
  • FTA and its affiliate First Trust Portfolios L.P. ("FTP"), a FINRA registered broker-dealer, are privately-held companies that provide a variety of investment services.
  • FTP is also a distributor of mutual fund shares and exchange-traded fund creation units.
  • The Fund principally invests in a global portfolio of infrastructure stocks in a range of currencies and senior secured loans.

Teledyne to Participate at the TD Cowen Aerospace & Defense Conference

Retrieved on: 
Monday, February 12, 2024

Teledyne Technologies Incorporated (NYSE:TDY) today announced that George Bobb, President and Chief Operating Officer, and Jason VanWees, Vice Chairman, will participate at the TD Cowen 45th Annual Aerospace & Defense Conference on Tuesday, February 13.

Key Points: 
  • Teledyne Technologies Incorporated (NYSE:TDY) today announced that George Bobb, President and Chief Operating Officer, and Jason VanWees, Vice Chairman, will participate at the TD Cowen 45th Annual Aerospace & Defense Conference on Tuesday, February 13.
  • Teledyne Technologies is a leading provider of sophisticated digital imaging products and software, instrumentation, aerospace and defense electronics, and engineered systems.
  • Teledyne’s operations are primarily located in the United States, Canada, the United Kingdom, and Western and Northern Europe.
  • Forward-looking statements involve risks and uncertainties, are based on the current expectations of the management of Teledyne and are subject to uncertainty and changes in circumstances.

Transaction in Own Shares

Retrieved on: 
Monday, February 12, 2024

These share purchases form part of the on- and off-market limbs of the Company's existing share buy-back programme previously announced on 1 February 2024.

Key Points: 
  • These share purchases form part of the on- and off-market limbs of the Company's existing share buy-back programme previously announced on 1 February 2024.
  • In respect of this programme, Citigroup Global Markets Limited will make trading decisions in relation to the securities independently of the Company for a period from 1 February 2024 up to and including 26 April 2024.
  • The on-market limb will be effected within certain pre-set parameters and in accordance with the Company’s general authority to repurchase shares on-market.
  • The off-market limb will be effected in accordance with the Company’s general authority to repurchase shares off-market pursuant to the off-market buyback contract approved by its shareholders and the pre-set parameters set out therein.