UK

European Medicines Agency Validates Santhera’s Marketing Authorization Application for Vamorolone in Duchenne Muscular Dystrophy

Retrieved on: 
Monday, October 31, 2022
Safety, NINDS, Leber's hereditary optic neuropathy, Vomiting, LHON, JAMA Network Open, Vamorolone, Microdeletion syndrome, EC, Vitamin D deficiency, Cystic fibrosis, CMO, Dissociative, Patient, UK, Time, Foundation, EMA, JAMA, NCATS, Review, JAMA Neurology, Committee for Medicinal Products for Human Use, DMD, European Medicines Agency, Orphan drug, Food and Drug Administration Amendments Act of 2007, Life Science Alliance, CHMP, FDA, National, Defense, National Institutes of Health, Adolescence, Food, PIM, NIAMS, NDA, Muscular dystrophy, Company, Duchenne muscular dystrophy, Union, European Commission, MAA, Vaccine, Pharmaceutical industry, Wood drying, MD, Duchenne

Pratteln, Switzerland, October 31, 2022 Santhera Pharmaceuticals (SIX: SANN) announces that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD).

Key Points: 
  • Pratteln, Switzerland, October 31, 2022 Santhera Pharmaceuticals (SIX: SANN) announces that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD).
  • Subject to EC approval, expected later in 2023, vamorolone will receive marketing authorization in all member states of the European Union, as well as in Norway, Liechtenstein and Iceland.
  • Santhera has submitted a new drug application (NDA) to the U.S. FDA and a marketing authorization application (MAA) to the European Medicines Agency (EMA) for vamorolone for the treatment of DMD.
  • ReveraGen was founded in 2008 to develop first-in-class dissociative steroidal drugs for Duchenne muscular dystrophy and other chronic inflammatory disorders.

KBRA Publishes Atlas Corp.’s Issuer Rating of BB+, Stable

Retrieved on: 
Monday, October 31, 2022
Banking, Professional Services, Finance, National Association, National Association of Insurance Commissioners, MSC, Time, Ontario Securities Commission, Outlook, Government, Hapag-Lloyd, European Securities and Markets Authority, EBITDA, CMA, Maintenance, U.S. Securities and Exchange Commission, Oklahoma Insurance Commissioner, UK, Industry, Atlas Corporation, Risk, Movement, COSCO, Jetivia SA v Bilta (UK) Limited (in liquidation), APR, Prospectus, Credit, ONE, Growth, KBRA, TEU, CRA, ESG, CMA CGM, St. Louis Fed Financial Stress Index, LLC, Efficiency, BB, Security (finance), Airline, Telescopic sight, Seaspan ULC, Maersk

KBRA publishes the BB+ issuer rating assigned to Atlas Corp. (Atlas or the Company).

Key Points: 
  • KBRA publishes the BB+ issuer rating assigned to Atlas Corp. (Atlas or the Company).
  • On September 23, 2022, Kroll Bond Rating Agency (KBRA) initially assigned an unpublished BB+ issuer rating to Atlas Corp. with a Stable Outlook.
  • In the absence of material debt obligations at the holding company level, the issuer rating for Atlas is aligned with the Seaspan issuer rating of BB+.
  • The rating of Atlas Corp. has a Stable Outlook; therefore, a rating upgrade in the near future is not expected.

UN privacy rapporteur to join Australian Privacy Awareness Week 2016

Retrieved on: 
Monday, October 31, 2022
Knowledge, Edith Cowan University, Australian Government Linked Data Working Group, Information policy, International Assessment of Agricultural Knowledge, Science and Technology for Development, Campaign Against an EU Constitution, Health, Breakfast, Time, Government, University of Groningen, United Nations Human Rights Council, APPA, Treaty establishing a Constitution for Europe, RESPECT, British Computer Society, United Nations special rapporteur, Private law, Ashgate Publishing, UN, UK, Internet governance, Awareness, Attention, United Nations, Information technology, Textbook, Internet, Department, Breakfast News, School, Estonian Academy of Security Sciences, IEEE Computer Society, Expert, Science, SMART, Computer, Faculty, UNSW Faculty of Law, University, Birth control, Online shopping, Management, Privacy

= UN privacy rapporteur to join Australian Privacy Awareness Week 2016 =

Key Points: 
  • = UN privacy rapporteur to join Australian Privacy Awareness Week 2016 =
    Acting Australian Information Commissioner, Timothy Pilgrim, announced today that this years Privacy Awareness Week will take on an international perspective, with the first visit to Australia by the United Nations Special Rapporteur for Privacy, Professor Joseph (Joe) Cannataci.
  • Privacy Awareness Week will be held from Sunday 15 to Saturday 21 May this year.
  • The week promotes awareness and discussion with business, government agencies and the broader community on how to protect and respect the privacy rights of Australian citizens.
  • Mr Pilgrim described the UN Rapporteurs involvement this year as being important for furthering privacy awareness and debate on a range of domestic and international privacy issues in Australia.
  • His work has already increased attention and debate on privacy rights, particularly in a digital context, and I know his involvement will elevate this years Privacy Awareness Week events and discussions.
  • Professor Cannataci confirmed he would be the key speaker at the OAICs annual Privacy Awareness Business Breakfast, to be held on May 16 in Sydney, and that other Privacy Awareness Week engagements were being developed in conjunction with his office.
  • I am delighted to accept the kind invitation of Commissioner Pilgrim to visit Australia, especially during Privacy Awareness Week.
  • *Media contact: *Alison Wares 0407 663 968 [email protected] Privacy Awareness Week is an annual initiative of the Asia Pacific Privacy Authorities (APPA) forum.

ICO launches second consultation on the draft Data protection and journalism code

Retrieved on: 
Monday, October 31, 2022
Privacy, ICO, FOIA, EIR, Environmental Information Regulations 2004, GDPR, Freedom of Information Act 2000, PECR, UK, General Data Protection Regulation, Information privacy, Industry, Information, Review, DPA, Lawyer, Telecommunication, Journalism, Freedom, Privacy and Electronic Communications (EC Directive) Regulations 2003, Cryptocurrency, Medical device, Public relations, Risk management, Data

The Information Commissioners Office (ICO) has launched a second consultation on a draft code of practice about using personal data for journalism (the code).

Key Points: 
  • The Information Commissioners Office (ICO) has launched a second consultation on a draft code of practice about using personal data for journalism (the code).
  • The code provides practical guidance on how to comply with data protection legal requirements and good practice when using personal data for journalism.
  • Notes to Editors
    About the draft Data protection and journalism code
    - The DPA 2018 requires the ICO to produce a code of practice that provides practical guidance for organisations and individuals processing personal data for the purposes of journalism.
  • - The draft code builds on Data protection and journalism: a guide for the media published in 2014.

Home Office warned after sensitive documents left at London venue

Retrieved on: 
Monday, October 31, 2022
Privacy, ICO, FOIA, EIR, Government, Metropolitan Police, R v Secretary of State for the Home Department, ex parte Northumbria Police Authority, State, Environmental Information Regulations 2004, Home Office, Freedom of Information Act 2000, Commissioner, PECR, United Kingdom, UK, Information commissioner, Information privacy, Home, Data Protection Act 1998, Information, Review, Metropolitan, Record, Telecommunication, Freedom, Privacy and Electronic Communications (EC Directive) Regulations 2003, Cryptocurrency

The ICO has issued a formal reprimand to the Home Office, after sensitive documents were found at a public London venue.

Key Points: 
  • The ICO has issued a formal reprimand to the Home Office, after sensitive documents were found at a public London venue.
  • The documents, which were handed by venue staff to police in September 2021, included two Extremism Analysis Unit Home Office reports and a Counter Terrorism Policing report.
  • A government investigation concluded the Home Office was the most likely source of the documents.
  • The ICO found that the Home Office had failed to ensure an appropriate level of security of personal data, including where documents were classified as Official Sensitive.

Lloyds Bank plc 2022 Q3 Interim Management Statement

Retrieved on: 
Thursday, October 27, 2022
Financial Conduct Authority, ECL, Growth, Group, Movement, Amortization, Income, RCF, RNS, London, Reading, HBOS, UK, COVID-19, United Kingdom, London Stock Exchange, UK Government G-Cloud, Lloyds Banking Group, Commercial bank, Web browser, Reinsurance, Bank, Online gambling

Net interest income was 9,458 million, an increase of 1,209 million compared to 8,249million in the nine months to 30September 2021.

Key Points: 
  • Net interest income was 9,458 million, an increase of 1,209 million compared to 8,249million in the nine months to 30September 2021.
  • Other income was 162million lower at 2,661 million in the nine months to 30 September 2022 compared to 2,823million in the same period last year.
  • Total operating expenses decreased by 131 million to 6,629 million compared to 6,760million in the first nine months of 2021.
  • Total assets were 24,590 million, or 4 per cent, higher at 627,439 million at 30 September 2022 compared to 602,849million at 31December 2021.

Santhera and ReveraGen Complete NDA Submission to FDA for Vamorolone in Duchenne Muscular Dystrophy

Retrieved on: 
Thursday, October 27, 2022
JAMA Neurology, Life expectancy, Union, Muscular dystrophy, PIM, European Medicines Agency, UK, Vamorolone, NINDS, FDA, Dissociative, Ventilation, National Institutes of Health, MAA, Foundation, JAMA Network Open, Inflammation, CEO, Vitamin D deficiency, Food, Patient, Maintenance, Life Science Alliance, Cardiomyopathy, NDA, Heart, Orphan drug, Duchenne muscular dystrophy, Defense, EMA, NIAMS, Company, Weakness, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Doctor of Philosophy, Safety, Disease, LHON, DMD, National, European Commission, Leber's hereditary optic neuropathy, Adolescence, NCATS, Fibrosis, Microdeletion syndrome, Prednisone, Cystic fibrosis, Vomiting, Caregiver, Time, Pharmaceutical industry, Duchenne, MD

Completion of the vamorolone NDA submission is a major step towards our goal of bringing this investigational therapy to patients living with DMD, and represents a vital milestone for Santhera, said Dario Eklund, CEO of Santhera.

Key Points: 
  • Completion of the vamorolone NDA submission is a major step towards our goal of bringing this investigational therapy to patients living with DMD, and represents a vital milestone for Santhera, said Dario Eklund, CEO of Santhera.
  • With the completion of the rolling NDA submission, Santhera and ReveraGen have also applied for priority review.
  • ReveraGen was founded in 2008 to develop first-in-class dissociative steroidal drugs for Duchenne muscular dystrophy and other chronic inflammatory disorders.
  • The development of ReveraGens lead compound, vamorolone, has been supported through partnerships with foundations worldwide, including Muscular Dystrophy Association USA, Parent Project Muscular Dystrophy, Foundation to Eradicate Duchenne, Save Our Sons, JoiningJack, Action Duchenne, CureDuchenne, Ryans Quest, Alexs Wish, DuchenneUK, Pietros Fight, Michaels Cause, Duchenne Research Fund, and Defeat Duchenne Canada.

KBRA Assigns Preliminary Ratings to Flagship Credit Auto Trust 2022-4

Retrieved on: 
Wednesday, October 26, 2022
Professional Services, Finance, U.S. Securities and Exchange Commission, Insurance commissioner, CRA, European Securities and Markets Authority, ESG, LLC, National Association, Ontario Securities Commission, UK, KBRA, Jetivia SA v Bilta (UK) Limited (in liquidation), Prospectus, Credit, National Association of Insurance Commissioners, Security (finance)

Further disclosures relating to this rating action are available in the Information Disclosure Form(s) referenced above.

Key Points: 
  • Further disclosures relating to this rating action are available in the Information Disclosure Form(s) referenced above.
  • Additional information regarding KBRA policies, methodologies, rating scales and disclosures are available at www.kbra.com .
  • Kroll Bond Rating Agency, LLC (KBRA) is a full-service credit rating agency registered with the U.S. Securities and Exchange Commission as an NRSRO.
  • KBRA is also recognized by the National Association of Insurance Commissioners as a Credit Rating Provider.

KBRA Assigns Preliminary Ratings to MMAF Equipment Finance LLC 2022-B

Retrieved on: 
Wednesday, October 26, 2022
Professional Services, Finance, U.S. Securities and Exchange Commission, Insurance commissioner, CRA, European Securities and Markets Authority, ESG, LLC, National Association, Ontario Securities Commission, UK, KBRA, Jetivia SA v Bilta (UK) Limited (in liquidation), Prospectus, Credit, National Association of Insurance Commissioners, Security (finance)

Further disclosures relating to this rating action are available in the Information Disclosure Form(s) referenced above.

Key Points: 
  • Further disclosures relating to this rating action are available in the Information Disclosure Form(s) referenced above.
  • Additional information regarding KBRA policies, methodologies, rating scales and disclosures are available at www.kbra.com .
  • Kroll Bond Rating Agency, LLC (KBRA) is a full-service credit rating agency registered with the U.S. Securities and Exchange Commission as an NRSRO.
  • KBRA is also recognized by the National Association of Insurance Commissioners as a Credit Rating Provider.

Rio Tinto issues letter to Turquoise Hill shareholders

Retrieved on: 
Tuesday, October 25, 2022
Professional Services, Natural Resources, Mining, Minerals, Finance, Financial Conduct Authority, National instrument, Rio Tinto, RBC, Capital Group Companies, Indian stock exchange, Research, TRQ, Rio Tinto (corporation), Publication, TD Securities, TD, Private Securities Litigation Reform Act, UK, Australian Securities Exchange, QC, Canaccord Genuity, NI, BMO, Failure, Disclosure, Ownership, Suite, Compliance, Circular, Iron ore, Security (finance), Property management, Scotiabank, Arrangement

The information contained in this press release is for informational purposes for the shareholders (Shareholders) of Turquoise Hill Resources Ltd. (TRQ) in order to provide the views of Rio Tinto plc (Rio Tinto) and its affiliates regarding the arrangement agreement entered into between Rio Tinto, Rio Tinto International Holdings Limited (RTIH) and TRQ, pursuant to which, RTIH would acquire the approximately 49% of the issued and outstanding common shares of TRQ (Common Shares) that it and its affiliates do not currently own for C$43.00 in cash per common share (the Arrangement) and other matters which Rio Tinto believes to be relevant to Shareholders.

Key Points: 
  • The information contained in this press release is for informational purposes for the shareholders (Shareholders) of Turquoise Hill Resources Ltd. (TRQ) in order to provide the views of Rio Tinto plc (Rio Tinto) and its affiliates regarding the arrangement agreement entered into between Rio Tinto, Rio Tinto International Holdings Limited (RTIH) and TRQ, pursuant to which, RTIH would acquire the approximately 49% of the issued and outstanding common shares of TRQ (Common Shares) that it and its affiliates do not currently own for C$43.00 in cash per common share (the Arrangement) and other matters which Rio Tinto believes to be relevant to Shareholders.
  • The views expressed in this press release represent the views and opinions of Rio Tinto as of the date hereof.
  • Rio Tinto currently beneficially owns 102,196,643 Common Shares, representing approximately 50.8% of the issued and outstanding Common Shares.
  • The person responsible for arranging the release of this announcement on behalf of Rio Tinto plc is Steve Allen, Group Company Secretary.