EU

Airbus to Provide Sales and Operations Support of Silent Arrow® UAS to European Markets

Retrieved on: 
Thursday, November 9, 2023
Airbus, A400M, Arrow, Airbus A400M Atlas, Lockheed Martin, Certification, C-17, Marketing, UAS, Lockheed, Boeing, ISO, Aviation, Airline, EU

LOS ANGELES, Nov. 9, 2023 /PRNewswire/ -- Silent Arrow today announced the signing of a Memorandum of Understanding between Airbus DS Airborne Solutions GmbH (Airbus), MEL Aviation Ltd and Yates Electrospace Corporation (dba Silent Arrow) to manufacture, distribute and support the Silent Arrow GD-2000 heavy cargo delivery UAS platform for European market segments to include:

Key Points: 
  • To facilitate the collaboration, Silent Arrow recently granted an exclusive license to MEL Aviation to manufacture the Silent Arrow GD-2000 and its spare parts for UK and EU markets in accordance with ISO AS9100 quality standards.
  • Airbus will then provide sales, marketing and after-sales support by leading the operational service model for Silent Arrow, to include:
    "We are thrilled to take our collaboration with MEL Aviation to the next level with Airbus joining the team to build and lead the service business for Silent Arrow across Europe," said Chip Yates, Silent Arrow's Founder and CEO.
  • The Silent Arrow GD-2000 is the world's first heavy payload, autonomous and attritable cargo delivery aircraft designed to carry 1,500 lbs.
  • of cargo over 40 miles when deployed from cargo aircraft such as the Lockheed Martin C-130, Boeing C-17 and Airbus A400M.

Ecommerce Pioneer GiftsforEurope Celebrates 25th Anniversary

Retrieved on: 
Thursday, November 9, 2023
Health, Cheese, MBA, B2B, Internet, Stefaan Sintobin, DNA, New Yorkers For Children, Mary Lily Kenan Flagler Bingham, Veuve Clicquot, Hand, Christmas, Christmas and holiday season, Mail order, Online shopping, Sales, EU

ARDOOIE, Belgium, Nov. 9, 2023 /PRNewswire/ -- GiftsforEurope (www.giftsforeurope.com), a leader in international gift delivery to Europe, celebrates its 25th anniversary in 2023. Nathalie and Benny Sintobin founded the website in 1998 during the early days of Internet shopping to make it easy to send gifts to Europe from abroad. From beginnings as a 5-person team in Roeselare, Belgium, today GiftsforEurope.com delivers corporate and personal gifts to 30+ European countries and the UK.

Key Points: 
  • ARDOOIE, Belgium, Nov. 9, 2023 /PRNewswire/ -- GiftsforEurope ( www.giftsforeurope.com ), a leader in international gift delivery to Europe, celebrates its 25th anniversary in 2023.
  • Now is the time to contact GiftsforEurope B2B specialists for corporate Christmas gifts for employees, clients, and colleagues in Europe.
  • GiftsforEurope initially delivered to Belgium, France, and the Netherlands, but quickly adapted to meet requests for delivery across Europe.
  • In his final reflection on the success of GiftsforEurope in the next 25 years, Mr. Sintobin concluded, "Gosh…I will be 80 then!"

EU Clinical Trials Regulation and Clinical Trials Information System, Upcoming Webinar Hosted by Xtalks

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Thursday, November 9, 2023
European Economic Area, CTIS, Database, Clinical trial, Gross metropolitan product, Pharmacy, European, Medical device, Health care, EU

TORONTO, Nov. 9, 2023 /PRNewswire-PRWeb/ -- Discover an informative webinar to unravel the complexity of the Clinical Trials Information System (CTIS) and explore the regulatory structure in Europe. Most importantly, the featured speakers will discuss whether all the latest changes in the regulatory landscape still position Europe as the number one destination for clinical trials.

Key Points: 
  • In this free webinar, unravel the complexity of the Clinical Trials Information System (CTIS) and explore the regulatory structure in Europe.
  • The featured speakers will discuss whether these recent regulatory changes still position Europe as a leading choice for conducting clinical trials.
  • TORONTO, Nov. 9, 2023 /PRNewswire-PRWeb/ -- Discover an informative webinar to unravel the complexity of the Clinical Trials Information System (CTIS) and explore the regulatory structure in Europe.
  • Join this webinar to gain insights into:
    If the implementation of CTIS destroyed the clinical trial environment in the EU?

Better Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Updates

Retrieved on: 
Thursday, November 9, 2023
Health, Diabetes, Neurology, Health Technology, Pharmaceutical, Cardiology, Biotechnology, FDA, Insurance, Standard of care, Research, Trial of the century, American College, First, Aircraft registration, American Gastroenterological Association, FSS, PDT, Food, AGA, Patent, ATM, Therapy, Regulation, Business development, Disclosure, Regulation of tobacco by the U.S. Food and Drug Administration, Type 2 diabetes, Marketing, Partnership, Webcast, Machine learning, Regulation Fair Disclosure, Better, Traction, CBT, Safety, AI, European, MASH, Patient, Prescription, Veteran, VA, Cognitive behavioral therapy, Pharmaceutical industry, Health insurance, Bank, T2D, EU

New Patent Issued: In September 2023, Better Therapeutics patent - "Managing lifestyle and health interventions with predictive analytics" - was issued in the European Union (EU).

Key Points: 
  • New Patent Issued: In September 2023, Better Therapeutics patent - "Managing lifestyle and health interventions with predictive analytics" - was issued in the European Union (EU).
  • Showcased AspyreRx at First Promotional Meeting: In October 2023, Better Therapeutics announced its participation at the American College of Lifestyle Medicine’s 2023 Annual Meeting.
  • Further Strengthen Financial Position: Better Therapeutics expects to further strengthen its financial position in the fourth quarter to extend its financial runway.
  • Better Therapeutics periodically provides other information for investors on its corporate website, http://www.bettertx.com , and its investor relations website, https://investors.bettertx.com .

Takeda Receives U.S. FDA Approval of FRUZAQLA™ (fruquintinib) for Previously Treated Metastatic Colorectal Cancer

Retrieved on: 
Wednesday, November 8, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Survival, VEGF, TAK, RAS, PDUFA, Food, Colorectal Cancer Alliance, MAA, Priority, JAMA, European Medicines Agency, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Medicines and Healthcare products Regulatory Agency, Priority review, PMDA, Colorectal cancer, CRC, EMA, FACP, Cancer, Metastasis, Patient, Diagnosis, Vanderbilt University Medical Center, Pharmaceutical industry, Takeda, EU, Lancet

"There is a pressing need for new treatments for individuals with metastatic colorectal cancer, who have had limited options and continue to face poor outcomes.

Key Points: 
  • "There is a pressing need for new treatments for individuals with metastatic colorectal cancer, who have had limited options and continue to face poor outcomes.
  • “For far too long, healthcare providers and patients have had limited options when selecting a therapy for metastatic colorectal cancer.
  • The trials investigated FRUZAQLA plus best supportive care versus placebo plus best supportive care in patients with previously treated mCRC.
  • “Colorectal cancer is a highly heterogeneous disease, making it difficult to bring advancements to patients whose cancer has metastasized.

VANFLYTA® Approved in the EU as the First FLT3 Inhibitor Specifically for Patients with Newly Diagnosed FLT3-ITD Positive AML

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Thursday, November 9, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, QT interval, Cardiac arrest, National Center for Health Research, Acute myeloid leukemia, ECG, European Commission, Hypokalemia, Committee, European Directive on Traditional Herbal Medicinal Products, Febrile neutropenia, MD, Professor, News, University Hospital Heidelberg, EC, Maintenance, Pneumonia, Arrhythmia, Ventricular fibrillation, ALAN, Civil service commission, Daiichi Sankyo, Risk, TSE, HR, Leukemia, FLT3, Committee for Medicinal Products for Human Use, Safety, German Cancer Research Center, European, Patient, Death, Neutropenia, AML, Nursing, Pharmaceutical industry, EU, Lancet

VANFLYTA is the first FLT3 inhibitor approved in the EU specifically for the treatment of patients with newly diagnosed FLT3-ITD positive AML, which represents about 25 to 30% of all new AML cases.1,2

Key Points: 
  • VANFLYTA is the first FLT3 inhibitor approved in the EU specifically for the treatment of patients with newly diagnosed FLT3-ITD positive AML, which represents about 25 to 30% of all new AML cases.1,2
    The authorization by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on the results of the QuANTUM-First trial, which were published in The Lancet .
  • The most common grade 3 or 4 treatment emergent adverse events (occurring in ≥ 10% of patients) were febrile neutropenia (43%), hypokalemia (19%), neutropenia (18%) and pneumonia (11%).
  • QTcF > 500 ms occurred in 2.3% of patients receiving VANFLYTA and 0.8% of patients discontinued VANFLYTA due to QT prolongation.
  • Two (0.8%) patients receiving VANFLYTA experienced cardiac arrest with recorded ventricular fibrillation on ECG (one with fatal outcome), both in the setting of severe hypokalemia.

ESMA encourages preparations for a smooth transition to MiCA

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Thursday, November 9, 2023
European Securities and Markets Authority, Economic and Financial Affairs Council, ESMA, Economy, ECOFIN, Letter, Cryptocurrency, EU

ESMA encourages preparations for a smooth transition to MiCA

Key Points: 
  • ESMA encourages preparations for a smooth transition to MiCA
    The European Securities and Markets Authority (ESMA), the EU’s financial markets regulator and supervisor, today publishes a letter and a statement to encourage preparations for a smooth transition to MiCA.
  • Market participants are encouraged to begin planning towards a smooth transition and ensure their clients are aware of the regulatory status of their ‘grand-fathered’ crypto-asset offerings.
  • The statement also reminds consumers of the risks associated with holding or investing in crypto-assets until and even after MiCA enters into application.
  • More information on the timeline for MiCA implementing measures and the transitional period can be found here.

ESMA finds natural gas futures markets functioned appropriately during the August 2022 price surge

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Thursday, November 9, 2023
Agency, Falls, May, March, ACER, European Securities and Markets Authority, Contract, ESMA, Time, CCP, Electricity, Annual report, Uncertainty, Natural gas, Cryptocurrency, EU

ESMA finds natural gas futures markets functioned appropriately during the August 2022 price surge

Key Points: 
  • ESMA finds natural gas futures markets functioned appropriately during the August 2022 price surge
    The European Securities and Markets Authority (ESMA), the EU’s financial markets regulator and supervisor, today publishes a study on the record surge in prices in European natural gas futures markets in August 2022.
  • Natural gas derivative markets came into the spotlight with the Russian invasion of Ukraine, which drove uncertainty and later led to falls in Russian supplies.
  • Despite the record prices during August 2022, the findings presented in the study do not show correspondingly high illiquidity.
  • Taken together, these elements suggest that markets continued to function appropriately during the August 2022 market events.

ESA’s Joint Board of Appeal suspends the decision by the European Securities and Markets Authority to withdraw the recognition decision of Dubai Commodities Clearing Corporation as a Tier 1 third-country central counterparty

Retrieved on: 
Thursday, November 9, 2023
European Securities and Markets Authority, Taith Joint Board, United Arab Emirates, CCP, Market, DCCC, European Data Protection Board, Board, EMIR, EU

ESA’s Joint Board of Appeal suspends the decision by the European Securities and Markets Authority to withdraw the recognition decision of Dubai Commodities Clearing Corporation as a Tier 1 third-country central counterparty

Key Points: 
  • ESA’s Joint Board of Appeal suspends the decision by the European Securities and Markets Authority to withdraw the recognition decision of Dubai Commodities Clearing Corporation as a Tier 1 third-country central counterparty
    The Joint Board of Appeal (“the Board”) of the European Supervisory Authorities (“ESAs”) decided that the application for suspension brought by Dubai Commodities Clearing Corporation (“DCCC”) against the European Securities and Markets Authority (“ESMA”) is admissible and suspends the ESMA Decision.
  • The application was brought in relation to ESMA’s Decision, adopted under Article 25p Regulation (EU) No 648/2012 (EMIR), to withdraw the recognition of DCCC as a Tier 1 third-country central counterparties (CCP) as a consequence of the United Arab Emirates (UAE) being included in the list of high-risk third countries provided for in the Commission Delegated Regulation (EU) 2016/1675.
  • DCCC challenged ESMA’s Decision, asking the Board to extend the adaptation period and to suspend the withdrawal Decision until the outcome of the appeal is concluded.
  • The Board finds that the appeal case is admissible and suspends the ESMA Decision.

European Supervisory Authorities publish joint criteria on the independence of supervisory authorities

Retrieved on: 
Thursday, November 9, 2023
Review, European Insurance and Occupational Pensions Authority, European Securities and Markets Authority, European Banking Authority, ESMA, EBA, Accountability, Supervision, EIOPA, Government, Pension, Pension fund, Property management, European, EU

European Supervisory Authorities publish joint criteria on the independence of supervisory authorities

Key Points: 
  • European Supervisory Authorities publish joint criteria on the independence of supervisory authorities
    The three European Supervisory Authorities– the European Banking Authority (EBA), European Insurance and Occupational Pensions Authority (EIOPA) and European Securities and Markets Authority (ESMA) (EBA, EIOPA and ESMA – the ESAs) – today published their joint criteria on the independence of supervisory authorities.
  • Supervisory independence is key to ensure that fair, effective and transparent decisions are taken by appropriately resourced supervisory authorities.
  • Building on these reports and based on the 2021 EIOPA’s criteria and international standards, the ESAs further worked together to issue joint criteria on the independence of supervisory authorities.
  • Next steps
    The criteria can be used by supervisory authorities as a tool to enhance their independence and, at a later stage, by the ESAs to assess supervisory independence in the EU.