European Commission

Orphan designation: cusatuzumab Treatment of acute myeloid leukaemia, 22/04/2020 Positive

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Thursday, April 18, 2024
Eurostat, Diagnosis, Civil service commission, Clinical research, Health, B cell, Growth, Cell, Bone marrow, Infection, AML, Disease, Patient, Committee, Knowledge, Regulation, CD70, Cancer, EMA, IRIS, Business park, Acute myeloid leukemia, European, COMP, European Commission, Blood, Azacitidine, Safety, Haematopoietic system, Marketing, Acute leukemia, Medicine, Pharmaceutical industry

Orphan designation: cusatuzumab Treatment of acute myeloid leukaemia, 22/04/2020 Positive

Key Points: 


Orphan designation: cusatuzumab Treatment of acute myeloid leukaemia, 22/04/2020 Positive

Orphan designation: Upifitamab rilsodotin Treatment of ovarian cancer, 09/12/2022 Positive

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Thursday, April 18, 2024
Community, Diagnosis, Civil service commission, Ovarian cancer, Cell death, Prevalence, Cell division, Disease, Clinical, Patient, Committee, EMA, IRIS, Agency, European, COMP, European Commission, Marketing, Medicine, Pharmaceutical industry

Overview

Key Points: 
  • Overview
    This medicine was designated as an orphan medicine for the treatment of ovarian cancer in the European Union on 9 December 2022.
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • Upifitamab rilsodotin is composed of an antibody that binds NaPi2b and a drug called AF-HPA which prevents cell division, resulting in cell death.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

Orphan designation: (S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester Treatment of pulmonary arterial hypertension, 20/04/2017 Positive

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Thursday, April 18, 2024
Eurostat, Blood pressure, Diagnosis, Tadalafil, Blood, Serotonin, Patient, Committee, Knowledge, Regulation, Prostacyclin, EMA, IRIS, Artery, Life expectancy, Heart failure, Orthostatic hypertension, European, Therapy, COMP, Heart, Safety, European Commission, Marketing, Pulmonary hypertension, Medicine, Pharmaceutical industry

Orphan designation: (S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester Treatment of pulmonary arterial hypertension, 20/04/2017 Positive

Key Points: 


Orphan designation: (S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester Treatment of pulmonary arterial hypertension, 20/04/2017 Positive

Orphan designation: Diacerein Treatment of epidermolysis bullosa, 20/02/2014 Positive

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Thursday, April 18, 2024
Eurostat, Diagnosis, Civil service commission, Gene, Anthraquinones, Skin cancer, Epidermolysis bullosa, Disease, Inflammation, Patient, Committee, Knowledge, Regulation, Keratin, EMA, IRIS, Joint, Protein, Life expectancy, Deformity, Blister, Interleukin-1 family, Mouth, European, Skin, Collagen, COMP, Infection, Safety, European Commission, Pain, Osteoarthritis, Marketing, Swelling, FGK, Medicine, Pharmaceutical industry

Orphan designation: Diacerein Treatment of epidermolysis bullosa, 20/02/2014 Positive

Key Points: 


Orphan designation: Diacerein Treatment of epidermolysis bullosa, 20/02/2014 Positive

Orphan designation: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-α-L-talofuranosyl)-paromamine sulfate Treatment of mucopolysaccharidosis type I, 22/09/2016 Positive

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Thursday, April 18, 2024
Eurostat, Diagnosis, Civil service commission, Death, Glycosaminoglycan, B cell, Enzyme, Mutation, Medicine, Cell, Mental disability, Disease, Patient, Committee, Knowledge, Scheie syndrome, Regulation, EMA, IRIS, Periodic breathing, Mucopolysaccharidosis, European, COMP, Enzyme replacement therapy, European Commission, Safety, DSM-IV codes, IQVIA, Marketing, Haematopoiesis, Liver, RDS, FGK, Hurler syndrome, MPS, Pharmaceutical industry

Orphan designation: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-α-L-talofuranosyl)-paromamine sulfate Treatment of mucopolysaccharidosis type I, 22/09/2016 Positive

Key Points: 


Orphan designation: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-α-L-talofuranosyl)-paromamine sulfate Treatment of mucopolysaccharidosis type I, 22/09/2016 Positive

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

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Thursday, April 18, 2024
Orbis, NACE, PRT, Premium, Employment, FRA, Economics, ITA, BACH, LVA, European Commission, GTA, ECB, Risk, CEIC, Ageing, Intangibles, Policy, Person, NGEU, TFP, GDP, GRC, NLD, EIA, RHS, Bureau of Economic Analysis, Database, Digital, European Economic Association, Journal, LUX, AUT, JPN, Frontier, Harmful, Trade Data Monitor, Gérard Schivardi, Lost, Attention, Growth, LHS, LTU, RRF, COVID-19, Rubric, Productivity, Bank, Capital, HICP, Social, METI, Total
Key Points: 

Central bank digital currency and monetary policy implementation

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Thursday, April 18, 2024
E41, Central bank digital currency, Atlantic Council, Research Papers in Economics, Remuneration, Norges Bank, People's Bank of China, Policy, Central Bank of Myanmar, Bank for International Settlements, Blog, Financial innovation, Sveriges Riksbank, Bank of Canada, Mechanics, Journal of Monetary Economics, Insurance, Bank of England, E42, Corridor, Quarterly Journal of Economics, Report card, Frankfurt, Appetite, American Economic Association, Digital rupee, Rosolin, RBI, PDF, Private, ECB, Committee, Inden, North Rhine-Westphalia, Bank, Canadian International Council, Social science, JEL, JMD, ECCB, Digital, Journal, Research, POC, European Central Bank, ENaira, M.A, Monetary economics, Section 5, Government, ISSN, The, Central bank, Finance, Buffer, Parliament, CBN, EONIA, Asset, ATM, Risk, International Monetary Fund, Interbank, Section 4, Ministry, Press release, Section 3, Human, Waterfall, Cryptocurrency, Economy, Swiss National Bank, PIB, Section 2, Conference, Reserve Bank, Reserve Bank of India, GBP, Progress, Road, American Economic Review, CBB, Digital currency, Agur, European Commission, International Settlement, Constraint, Money, Community business development corporation, City, Equivalence, Eligibility, Ministry of Finance, Report, Control, Civil service commission, EUR, Uncertainty, Eastern Caribbean Central Bank, Abadi, Rest, Reproduction, Fintech, IMF, Federal Reserve, LCR, Data
Key Points: 

    Feedback on the input provided by the European Parliament as part of its resolution on the ECB’s Annual Report 2022

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    Thursday, April 18, 2024
    Crypto, European banking union, Governance, Exercise, TARGET, Ciccarelli, Single, Climate, OJ, Ethics, Carbon, ECRB, Parliament, Council, European Systemic Risk Board, European Commission, Paris Agreement, Television, Annual, Letter, Speech, Employment, Social, ESRB, Euro, Prejudice, FSB, AML, ECB, Blog, Risk, ESCB, Committee, NGFS, Policy, Woman, Suggestion, Radio, GDP, Privacy, Weather, Person, Climate change, Communication, Digital, Intelligence, Economic and monetary union, SSM, Bias, Knowledge, Mentorship, EMU, Commission, Economy, Publication, Annual report, Financial Action Task Force, Orientation, Nickel, NPL, European Central Bank, Uncertainty, Financial Stability Board, Conference, NCBS, Treaty, Growth, Financial system, Central bank, European Parliament, Network, Natural Resources, COVID-19, Terrorism, Bank, Female, IMF, Multi-function printer, Recreation, Memorandum, Data, AMLA, Security printing

    Beyond managing related risks, the financial sector can also contribute to the transition toward a net-zero economy.

    Key Points: 
    • Beyond managing related risks, the financial sector can also contribute to the transition toward a net-zero economy.
    • Our work aims to enhance data transparency in climate change analysis, while informing monetary policy, financial stability and banking supervision.
    • The indicators we have developed focus on the euro area financial sector and are built from harmonised granular datasets.

    ESAs consult on technical standards for joint examination teams under DORA

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    Thursday, April 18, 2024
    RTS, EBA, Civil service commission, EIOPA, ESMA, ICT, European Commission, European

    ESAs consult on technical standards for joint examination teams under DORA

    Key Points: 
    • ESAs consult on technical standards for joint examination teams under DORA
      The European Supervisory Authorities (EBA, EIOPA and ESMA – the ESAs) launched today a public consultation on the draft Regulatory Technical Standards (RTS) on the conduct of oversight activities in relation to the joint examination teams under the Digital Operational Resilience Act (DORA).
    • The proposed technical standards take into account the high technical complexity of the oversight activities and the scarce availability of the expertise needed to perform them.
    • Legal basis, background and next steps
      These draft technical standards have been developed in accordance with Article 41(1) point (c) of DORA (Regulation (EU) 2022/2554).
    • The ESAs expect to submit these draft technical standards to the European Commission by 17 July 2024.

    20 Talks - Amandeep Singh Gill, UN Secretary General's Envoy on Technology

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    Thursday, April 18, 2024
    Civil service commission, Microsoft, Republic, EDPS, African Union, Private law, Information commissioner, Commission, Speech, Justice, Annual report, Heart, European Commission, EDPB, Intellectual property, Digitalization, Democrat, UN

    20 Talks - Amandeep Singh Gill, UN Secretary General's Envoy on Technology

    Key Points: 
    • 20 Talks - Amandeep Singh Gill, UN Secretary General's Envoy on Technology
      In this episode, our guest is Amandeep Singh Gill, UN Secretary General's Envoy on Technology.
    • In this episode, our guest is Amandeep Singh Gill, UN Secretary General's Envoy on Technology.
    • The EDPS presents its Annual Report 2023, summarising its key achievements in an evolving digital and regulatory landscape.
    • Read Press Release
      Read the decision
      On 20 June 2024, we invite you to the European Data Protection Summit: “Rethinking Data in a Democratic Society”.