European Economic Area

AGTech Announces Second Interim Results Ended December 31, 2023, Revenue Increases 69% Year-on-Year

Retrieved on: 
Wednesday, March 13, 2024

AGTech Announces Second Interim Results Ended December 31, 2023, Revenue Increases 69% Year-on-Year

Key Points: 
  • AGTech Announces Second Interim Results Ended December 31, 2023, Revenue Increases 69% Year-on-Year
    (Hong Kong, February 23, 2024) – AGTech Holdings Limited (“AGTech” or the “Group”, HKEX stock code: 8279) today announced its second interim results for the twelve months ended December 31, 2023.
  • • EBITDA of the Group for the 12-Month Period was approximately HK$39.5 million (Twelve months ended December 31, 2022: Negative EBITDA of approximately HK$37.7 million).
  • The profit for the 12-Month Period was approximately HK$29 million (12 months ended December 31, 2022: loss of approximately HK$131 million).
  • The change from operating loss to profit was mainly due to: (1) the increase in total revenue; (2) the increase in net finance income.

Bearing AI Launches EU ETS Compliance Tool

Retrieved on: 
Wednesday, March 6, 2024

Compliance with EU ETS is an imposing challenge for the maritime sector.

Key Points: 
  • Compliance with EU ETS is an imposing challenge for the maritime sector.
  • Bearing AI is meeting this challenge head-on with a new EUA forecast and simulation capability.
  • When uploading a vessel schedule to the FDO platform, our advanced AI provides a projection of specific vessels’ EU ETS obligations for that schedule.
  • This refined tool not only aids in navigating the immediate financial landscape shaped by the EU ETS but also aligns with long-term environmental stewardship by facilitating proactive carbon footprint management.

Verizon announces accepted amounts and pricing terms of its tender offers for five series of its debt securities

Retrieved on: 
Thursday, February 29, 2024

(2) Payable per each €1,000 principal amount of each specified series of Notes validly tendered at or prior to the Early Participation Date and accepted for purchase.

Key Points: 
  • (2) Payable per each €1,000 principal amount of each specified series of Notes validly tendered at or prior to the Early Participation Date and accepted for purchase.
  • Kroll Issuer Services Limited is acting as the Tender Agent and the Information Agent for the Offers.
  • You may also contact your broker, dealer, commercial bank, trust company or other nominee for assistance concerning the Offers.
  • In this communication Verizon has made forward-looking statements, including regarding the conduct and completion of the Offers.

Verizon announces cap increase and early participation results for tender offers for five series of its debt securities

Retrieved on: 
Thursday, February 29, 2024

The Offers will each expire at 4:00 p.m. (London time) on March 14, 2024, unless extended by Verizon.

Key Points: 
  • The Offers will each expire at 4:00 p.m. (London time) on March 14, 2024, unless extended by Verizon.
  • All conditions to the Offers were deemed satisfied by Verizon by the Early Participation Date, or timely waived by Verizon.
  • Accordingly, Verizon will settle all Notes validly tendered at or prior to the Early Participation Date and accepted for purchase, on March 4, 2024 (the “Early Settlement Date”).
  • The Total Consideration for each series of Notes includes an early participation payment of €50 per €1,000 principal amount of Notes.

LivaNova Announces Pricing of Private Offering of $300 Million of 2.50% Convertible Senior Notes Due 2029

Retrieved on: 
Wednesday, March 6, 2024

Prior to December 15, 2028, the notes will be convertible only upon satisfaction of certain conditions.

Key Points: 
  • Prior to December 15, 2028, the notes will be convertible only upon satisfaction of certain conditions.
  • If the initial purchasers of the notes exercise their option to purchase additional notes, LivaNova expects to enter into additional capped call transactions with the option counterparties.
  • The cash exchangeable senior notes were issued by LivaNova USA, Inc. and are guaranteed by LivaNova.
  • In connection with the issuance of the cash exchangeable senior notes, LivaNova USA, Inc. entered into capped call transactions with certain financial institutions.

Impact of the In-Vitro Diagnostic Regulation (IVDR) on the Conduct of Clinical Trials in the EU and CRO Outsourcing - 2024 Report - ResearchAndMarkets.com

Retrieved on: 
Tuesday, March 5, 2024

The "Impact of the InVitro Diagnostic Regulation (IVDR) on the Conduct of Clinical Trials in the EU and CRO Outsourcing - 2024" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Impact of the InVitro Diagnostic Regulation (IVDR) on the Conduct of Clinical Trials in the EU and CRO Outsourcing - 2024" report has been added to ResearchAndMarkets.com's offering.
  • In Vitro Diagnostic (IVD) tests are critical to clinical trial operations, serving to help select patients in clinical trials, provide accurate efficacy results, monitor patient response, and more.
  • As a result, current and pending drug clinical trials utilizing IVD tests now must also adhere to the IVDR.
  • However, this process is currently complex and uncoordinated, resulting in delays in clinical trials and patients waiting longer to participate in clinical trials, or even not participating at all.

LivaNova Announces Proposed Private Offering of $300 Million of Convertible Senior Notes

Retrieved on: 
Monday, March 4, 2024

The interest rate, conversion rate and other terms of the notes are to be determined upon pricing of the offering.

Key Points: 
  • The interest rate, conversion rate and other terms of the notes are to be determined upon pricing of the offering.
  • If the initial purchasers of the notes exercise their option to purchase additional notes, LivaNova expects to enter into additional capped call transactions with the option counterparties.
  • The cash exchangeable senior notes were issued by LivaNova USA, Inc. and are guaranteed by LivaNova.
  • In connection with the issuance of the cash exchangeable senior notes, LivaNova USA, Inc. entered into capped call transactions with certain financial institutions.

Gilead to Present Late-Breaking Data and Real-World Evidence Highlighting Innovative Antiviral Portfolio and Research Pipeline at CROI 2024

Retrieved on: 
Monday, February 26, 2024

Outcomes from pipeline research studies will also provide insights into investigational treatment candidates, including the novel combination regimen of lenacapavir plus bictegravir.

Key Points: 
  • Outcomes from pipeline research studies will also provide insights into investigational treatment candidates, including the novel combination regimen of lenacapavir plus bictegravir.
  • Additionally, a late-breaker oral presentation of Week 24 data from the INSIGHT trial evaluating Biktarvy in people with HIV and tuberculosis will be presented.
  • Gilead will present new data evaluating the safety and efficacy of Hepcludex® (bulevirtide) in people living with the coinfections of HIV, hepatitis B (HBV) and hepatitis delta (HDV).
  • Biktarvy combines the novel, unboosted INSTI bictegravir, with the Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, F/TAF) backbone.

Intercontinental Exchange, Inc. Commences Consent Solicitation with Respect to Black Knight InfoServ, LLC’s Outstanding 3.625% Senior Notes Due 2028

Retrieved on: 
Tuesday, February 20, 2024

Intercontinental Exchange, Inc. (NYSE: ICE) (“ICE”) announced today that it is commencing a consent solicitation (the “Consent Solicitation”) with respect to the outstanding 3.625% Senior Notes due 2028 (CUSIP Nos.

Key Points: 
  • Intercontinental Exchange, Inc. (NYSE: ICE) (“ICE”) announced today that it is commencing a consent solicitation (the “Consent Solicitation”) with respect to the outstanding 3.625% Senior Notes due 2028 (CUSIP Nos.
  • 092174AA9 (144A) and U0921BAA6 (Reg S)) (the “BK Notes”) issued by Black Knight InfoServ, LLC (“BK”), a wholly owned subsidiary of ICE.
  • The Consent Solicitation is being made upon the terms and conditions set forth in a consent solicitation statement, dated February 20, 2024 (the “Consent Solicitation Statement”), copies of which will be made available to holders of the BK Notes.
  • The Consent Solicitation is conditioned upon certain conditions set forth in the Consent Solicitation Statement.

Questions and answers on the European Union framework for (traditional) herbal medicinal products, including those from a ‘non-European’ tradition

Retrieved on: 
Sunday, March 10, 2024

1

Key Points: 
    • 1
      Committee on Herbal Medicinal Products (HMPC)

      Questions & Answers on the European Union framework
      for (traditional) herbal medicinal products, including those
      from a ?non-European? tradition

      Table of Content
      1.

    • European Pharmacopoeia

      SAWP

      Scientific Advice Working Party

      SmPC

      Summary of Product Characteristics

      THMP

      Traditional Herbal Medicinal Product

      TUR

      Traditional Use Registration

      WEU

      Well-Established Use

      Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.

    • Terminology of herbal medicinal products (Q&A 1-4)

      Question 1
      What are herbal substances, herbal preparations, and herbal medicinal products?

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Question 4
      Are food supplements regulated under the European Union (EU) pharmaceutical legislation
      for (traditional) herbal medicinal products ((T)HMPs)?
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Regulation of herbal medicinal products in the European Union (Q&A 511)

      Question 5
      Where to find the pharmaceutical legislation and dossier requirements for herbal medicinal
      products (HMPs), including traditional herbal medicinal products (THMPs), in the European
      Union (EU)?

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • These countries have,
      through the EEA agreement, adopted the complete Union acquis on medicinal products and are
      consequently parties to the Union procedures.
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Specific provisions for traditional herbal medicinal products (Q&A 1221)

      Question 12
      Which indications can be granted for traditional herbal medicinal products (THMPs)?

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Nov. 2023
      Answer 17

      Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Question 29
      Does the Committee on Herbal Medicinal Products (HMPC) hold a specific database on
      (registered) authorised (traditional) herbal medicinal products ((T)HMPs)?
    • Discussion with Member States intended to be

      Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.