DRSP

ESMA in 2022 - Focus on financial stability and investor protection

Retrieved on: 
Monday, June 19, 2023
Exercise, Review, Uncertainty, Financial Oversight and Management Board for Puerto Rico, DRSP, Markets in Financial Instruments Directive 2014, European Securities and Markets Authority, DLT, Name, Prospectus, Civil List Act 1979, Annual report, CRA, European, ESG, ESMA, Environment, Cryptocurrency, Property management, Management, Creative industries, EU, Brexit, Euribor

ESMA in 2022 - Focus on financial stability and investor protection

Key Points: 
  • ESMA in 2022 - Focus on financial stability and investor protection
    The European Securities and Markets Authority (ESMA), the EU’s financial markets regulator and supervisor, has published its Annual Report for 2022.
  • ESMA also delivered extensive work throughout the year to respond to the consequences of the Russian invasion of Ukraine.
  • Verena Ross, Chair of ESMA, said:
    “During 2022 ESMA designed its new strategic orientation for the next five years.
  • We will remain focused on our core mission of enhancing investor protection, promoting orderly financial markets and safeguarding financial stability.

Mithra - Letter to Shareholders and Corporate Update

Retrieved on: 
Thursday, May 25, 2023
Highbridge, Gedeon Richter, Letter, Mayo Clinic, Drawing, Endometrium, Therapy, Arthralgia, File, Marketing, Birth, Silence Therapeutics, NDA, BL 2.75-inch mountain gun, Ageing, Woman, Quality of life, Hospira, Research, Negotiation, Attention, Brain, DRSP, Hot, GSI, MITRA, Incidence, Communication, EUR, Dementia, CDMO, System, Patient, CEST, Estrogen, Brussels Stock Exchange, Menopause, Liver, Growth, Mortality, MAA, FDA, Zealand Pharma, Management, Risk management, Pharmaceutical industry, Medical device, Security (finance), Mithra, Estetrol, White box

Donesta® filing rescheduled for H2 2023 - still expecting U.S. approval in H1 2024

Key Points: 
  • Donesta® filing rescheduled for H2 2023 - still expecting U.S. approval in H1 2024
    Liege, Belgium, 25 May 2023 – 7:30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, (the "Company" or "Mithra"), today published a Corporate Update and Letter to Shareholders from recently appointed Chief Executive Officer, Dr. David Horn Solomon.
  • I accepted the role because my analysis revealed strong fundamentals and tremendous potential to create significant value for Mithra shareholders.
  • Collectively, the Mithra leadership understands that our ability to create value for our shareholders is a primary directive that goes hand in hand with developing medicines for women.
  • I look forward to continuing with increased transparency and regular communications to providing updates on our progress to you, our shareholders.

Morgan Stanley First Quarter 2023 Earnings Results

Retrieved on: 
Wednesday, April 19, 2023
Banking, Professional Services, Finance, Central Registry of Securitisation Asset Reconstruction and Security Interest, European Central Bank, European Market Infrastructure Regulation, DRSP, Authorization, European Securities and Markets Authority, Use, Wild Arms, ESRB, SFTR, Central bank, Quality, Roaming Regulation 2022, TRS, European Systemic Risk Board, ECB, Apas, ESMA, EMIR, Trade Repository, Risk management, Cryptocurrency, Medical device, Property management, EU, Markets in Financial Instruments Directive 2014

ESMA finds data quality significantly improves under new monitoring approach

Key Points: 

<span class="field field--name-title field--type-string field--label-hidden">ESMA finds data quality significantly improves under new monitoring approach </span>
<span class="field field--name-uid field--type-entity-reference field--label-hidden"><span>iris.hude@esma…</span></span>
<span class="field field--name-created field--type-created field--label-hidden">19 April 2023</span>

  &lt;div class=&quot;field field--name-field-news-section field--type-entity-reference field--label-hidden field__items&quot;&gt;
          &lt;div class=&quot;field__item&quot;&gt;&lt;a href=&quot;https://www.esma.europa.eu/press-news/esma-news?tid%5B0%5D=6206&quot; hreflang=&quot;en&quot;&gt;Market data&lt;/a&gt;&lt;/div&gt;
      &lt;/div&gt;

        &lt;div class=&quot;clearfix text-formatted field field--name-field-news-introduction field--type-text-long field--label-hidden field__item&quot;&gt;&lt;p&gt;The European Securities and Markets Authority (ESMA), the EU’s financial markets regulator and supervisor, today published the &lt;a href=&quot;https://www.esma.europa.eu/sites/default/files/2023-04/ESMA74-427-719_2022_Report_on_Quality_and_Use_of_Transaction_Data.pdf&quot;&gt;third edition of its Data Quality Report&lt;/a&gt; under the European Markets Infrastructure Regulation (EMIR) and the Securitised Financing Transactions Regulation (SFTR) reporting regimes. &lt;/p&gt;

</div>

        &lt;div class=&quot;clearfix text-formatted field field--name-field-news-body field--type-text-long field--label-hidden field__item&quot;&gt;&lt;p&gt;The report highlights the increased use of transaction data by EU financial regulatory authorities in their day-to-day supervision and identifies significant quality improvements following a new approach to data monitoring. In addition, it sets out how ESMA, together with the National Competent Authorities (NCAs), the European Central Bank (ECB) and the European Systemic Risk Board (ESRB), has incorporated key insights from its data monitoring in several internal workstreams. &lt;/p&gt;

<p>The new framework, adopted in 2022, takes a more data-driven and outcome-focused approach to data monitoring and to collaborating with the NCAs on data quality issues under EMIR and SFTR. </p>
<p>Specifically, it consists of two new elements: </p>
<ul><li>a centralised data quality dashboard with EU-wide indicators covering the most fundamental data quality aspects under EMIR;</li>
<li>a data sharing framework that enables relevant authorities to follow up with counterparties when potentially significant data quality issues are detected  </li>
</ul><p>New this year is the analysis of MiFiR transaction data from Authorized Reporting Mechanisms (ARMs) and Approved Publication Arrangements (APAs), following on from ESMA’s new supervisory powers over Data Reporting Services Providers (DRSPs).  </p>
<p>The methodology underlying the new approach is based on ESMA’s long-standing experience as supervisor of Trade Repositories (TRs) under EMIR and SFTR.</p>
<h4>Next steps   </h4>
<p>ESMA and the NCAs will continue to work on extending the new monitoring framework beyond EMIR and SFTR in 2023.  </p>
<p>Continued collaboration with NCAs and stakeholders such as Repositories, DRSPs and reporting entities is crucial to achieving further improvements to data quality under the relevant reporting regimes.</p>
<p> </p>
<p>Further information:</p>
<h6>Sarah Edwards</h6>
<p>Senior Communications Officer<br />
@ <a href="mailto:[email protected]">press@esma.europa.eu</a></p>
</div>

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<a href="https://www.esma.europa.eu/document/2022-report-quality-and-use-transact... rel="bookmark"><span class="field field--name-title field--type-string field--label-hidden">2022 Report on Quality and Use of Transaction Data</span>
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        &lt;div class=&quot;field field--name-field-news-hearing field--type-entity-reference field--label-hidden field__item&quot;&gt;&lt;a href=&quot;https://www.esma.europa.eu/press-news/hearings/webinar-2022-esma-data-quality-report&quot; hreflang=&quot;en&quot;&gt;Webinar on the 2022 ESMA Data Quality Report&lt;/a&gt;&lt;/div&gt;

ESMA finds data quality significantly improves under new monitoring approach

Retrieved on: 
Wednesday, April 19, 2023
Central Registry of Securitisation Asset Reconstruction and Security Interest, European Central Bank, European Market Infrastructure Regulation, National, DRSP, Authorization, Repository, Wild Arms, ESRB, SFTR, European Securities and Markets Authority, Central bank, TRS, European Systemic Risk Board, ECB, Apas, ESMA, EMIR, Trade Repository, Risk management, Cryptocurrency, Medical device, Property management, EU, Markets in Financial Instruments Directive 2014

ESMA finds data quality significantly improves under new monitoring approach

Key Points: 
  • ESMA finds data quality significantly improves under new monitoring approach
    The European Securities and Markets Authority (ESMA), the EU’s financial markets regulator and supervisor, today published the third edition of its Data Quality Report under the European Markets Infrastructure Regulation (EMIR) and the Securitised Financing Transactions Regulation (SFTR) reporting regimes.
  • The report highlights the increased use of transaction data by EU financial regulatory authorities in their day-to-day supervision and identifies significant quality improvements following a new approach to data monitoring.
  • The new framework, adopted in 2022, takes a more data-driven and outcome-focused approach to data monitoring and to collaborating with the NCAs on data quality issues under EMIR and SFTR.
  • Specifically, it consists of two new elements:
    - a centralised data quality dashboard with EU-wide indicators covering the most fundamental data quality aspects under EMIR;
    - a data sharing framework that enables relevant authorities to follow up with counterparties when potentially significant data quality issues are detected
    New this year is the analysis of MiFiR transaction data from Authorized Reporting Mechanisms (ARMs) and Approved Publication Arrangements (APAs), following on from ESMA’s new supervisory powers over Data Reporting Services Providers (DRSPs).

Acurx Announces Ibezapolstat Scientific Poster and Update on its Pol IIIC Pipeline Presented at ECCMID 2023 Scientific Conference

Retrieved on: 
Wednesday, April 19, 2023
ISLAND, VRE, Clostridioides difficile infection, DNA, DNA-binding protein, University, IV, Flagellum, Public, IIIC, MRSA, Infection, Genetically modified bacteria, Houston Community College, Solubility, DRSP, Movement, Congress, Professor, ECCMID, Vancomycin, European, Metronidazole, University of Houston, Fidaxomicin, Susceptibility, Poster, Principal, Pharmacology, Recurrence, Virulence, Safety, Microbiology, Vaccine, Pharmacy

C. difficile strains with reduced susceptibility to metronidazole, vancomycin, or fidaxomicin were susceptible to ibezapolstat, confirming its unique mechanism of action.

Key Points: 
  • C. difficile strains with reduced susceptibility to metronidazole, vancomycin, or fidaxomicin were susceptible to ibezapolstat, confirming its unique mechanism of action.
  • To study anti-virulence effect, our group investigated an under-studied virulence property of C difficile, namely, flagellar movement of the organism.
  • All of these positive and unexpected findings reflect the unique mode of action in inhibiting DNA pol IIIC and support the continued development of ibezapolstat to treat C. difficile infection."
  • The poster and presentation are available on the Company's website www.acurxpharma.com.

FDA Accepts Interim Analysis Plan for Ongoing Phase 2b Ibezapolstat Clinical Trial and Acurx Announces Presentations at ECCMID 2023 Scientific Conference

Retrieved on: 
Tuesday, April 11, 2023
VRE, CDI, University, IV, Public, IDMC, MRSA, Infection, PH2, Houston Community College, DRSP, Congress, Professor, ECCMID, Patient, European, University of Houston, Principal, FDA, Clostridioides difficile infection, IND, Pharmacology, Microbiology, Pharmaceutical industry, Vaccine, Pharmacy

The interim review will be conducted upon reaching enrollment of 36 patients in total.

Key Points: 
  • The interim review will be conducted upon reaching enrollment of 36 patients in total.
  • FDA's acceptance was based on the Company's filing of a protocol amendment to its Investigational New Drug Application (IND) with FDA in January 2023.
  • The Company's filing and intention for the IDMC to conduct an interim review of data was based on the observed blinded data to date from the ongoing Ph2b clinical trial at that time.
  • Additionally, spokespersons for the Company will be presenting at the 33rd Annual European Congress of Clinical Microbiology and Infectious Disease (ECCMID) this month.

Global Antimicrobial Resistance Diagnostics Market Report 2023: Availability of Better Diagnostics Tests and Kits Bolsters Growth - ResearchAndMarkets.com

Retrieved on: 
Thursday, January 5, 2023
Health, Biotechnology, AMR, Eyeish, Fungus, Methicillin, Subclinical infection, Bloodstream infections, DRC, Protein, Viral Research and Diagnostic Laboratories, Medication, Bacteria, Public health, Clostridium difficile, Pathogen, Immunoassay, NGS, DNA, Biotechnology, Urinary tract infection, Hospital, DRSP, Microbiology, CD, MRSA, Patient, Staphylococcus aureus, Pneumonia, Infection, Culture, Drug resistance, Catheter, Prevalence, PCR, Healthcare, Vaccine, Antibiotics, Copper

The Global Antimicrobial Resistance Diagnostics Market size is expected to reach $5.7 billion by 2028, rising at a market growth of 6.1% CAGR during the forecast period.

Key Points: 
  • The Global Antimicrobial Resistance Diagnostics Market size is expected to reach $5.7 billion by 2028, rising at a market growth of 6.1% CAGR during the forecast period.
  • Based on end user, the antimicrobial resistance diagnostics market is segmented into hospitals, diagnostic laboratories, pharmaceutical & biotechnology companies, and others.
  • The diagnostic laboratories garnered a remarkable growth rate in the antimicrobial resistance diagnostics market in 2021.
  • The North America segment procured the maximum revenue share in the antimicrobial resistance diagnostics market in 2021.

Acurx Pharmaceuticals, Inc. to Discuss 2022 Third Quarter Financial Results on November 14, 2022 Conference Call and Provide Business Update

Retrieved on: 
Tuesday, November 1, 2022
Security (finance), Marketing, MRSA, Clostridioides, DNA, Infection, IIIC, Clostridioides difficile (bacteria), Securities and Exchange Commission (Philippines), Annual report, Methicillin-resistant Staphylococcus aureus, Gram, VRE, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Gram-positive bacteria, CDI, Maintenance, GAIN, Private Securities Litigation Reform Act, Company, Clostridioides difficile infection, FDA, Enterococcus, Patient, Food, Fast Track, QIDP, CDC, Act, Firmicutes, GPSS, DRSP, Pharmaceutical industry, Actinobacteria

It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections.

Key Points: 
  • It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections.
  • The Company successfully completed Phase 1 and Phase 2a clinical trials of ibezapolstat.
  • The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI.
  • Acurx Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing new antibiotics for difficult to treat infections.

Acurx Pharmaceuticals, Inc. to Discuss 2022 Second Quarter Financial Results on August 16, 2022 Conference Call and Provide Business Update

Retrieved on: 
Thursday, August 4, 2022
Fast Track, Private Securities Litigation Reform Act, Annual report, Security (finance), Marketing, GPSS, Gram, Clostridioides difficile (bacteria), CDI, IIIC, Patient, Food, MRSA, Company, Clostridioides, Infection, QIDP, Enterococcus, Securities and Exchange Commission (Philippines), FDA, Maintenance, Act, VRE, DRSP, GAIN, Firmicutes, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Clostridioides difficile infection, DNA, Methicillin-resistant Staphylococcus aureus, Gram-positive bacteria, CDC, Pharmaceutical industry, Actinobacteria

It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections.

Key Points: 
  • It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections.
  • The Company successfully completed Phase 1 and Phase 2a clinical trials of ibezapolstat.
  • Acurx is currently enrolling patients in its Phase 2b vancomycin-controlled efficacy study in a 1:1 randomized trial of a total of 64 patients with CDI.
  • Acurx Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing new antibiotics for difficult to treat infections.

MAYNE PHARMA AND GOODRX ANNOUNCE NEW INITIATIVE TO INCREASE AWARENESS OF NEXTSTELLIS® AND EXPAND ACCESS TO BIRTH CONTROL

Retrieved on: 
Friday, July 29, 2022
Acquisition, Education, HCPS, Awareness, IQVIA, Hospira, Learning, DTC, Estetrol, Birth, Woman, SEC, Risk, GoodRx, Private Securities Litigation Reform Act, ASX, Safety, Pregnancy, Prescription, Technology, DRSP, Patient, MYX, Reproductive health, Annual report, Program, Digital, Pharmaceutical industry, Birth control, Fine chemical

The collaborative initiative will deliver an enhanced direct-to-consumer program aimed at building awareness of NEXTSTELLIS (E4/DRSP) oral contraceptive availability in the United States.

Key Points: 
  • The collaborative initiative will deliver an enhanced direct-to-consumer program aimed at building awareness of NEXTSTELLIS (E4/DRSP) oral contraceptive availability in the United States.
  • In addition, the initiative is focused on improving access to and raising awareness of available birth control methods.
  • It will also build awareness among HCPs, over 4,000 of whom have already written prescriptions for the product.
  • Mayne Pharma's CEO Scott Richards said, "We are excited to announce this strategic agreement with GoodRx at a time when providing choice, education, and access to birth control has never been more critical.