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Draft template for assessment report for the development of European herbal monographs and European Union list entries - Revision 6

Retrieved on: 
Thursday, April 18, 2024
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The completed comments form should be sent to

Key Points: 
    • The completed comments form should be sent to
      [email protected]
      10
      11
      Keywords

      Committee on Herbal Medicinal Products; HMPC; European Union herbal
      monographs; European Union list of herbal substances, preparations and
      combinations thereof for use in traditional herbal medicinal products; herbal
      medicinal products; traditional herbal medicinal products; traditional use;
      well-established medicinal use; benefit-risk assessment; assessment report

      12

      1
      2

      Changes introduced in section 6 Overall conclusions.

    • Peer-reviewer

      If not the same peer-reviewer
      since last version, all peerreviewers should be listed, and
      the version specified in
      brackets.

    • 22

      23


      on
      .

    • It is a working

      24

      document, not yet edited, and shall be further developed after the release for consultation of the

      25


      .

    • The principle of the template is to make clear
      distinctions between presentation of data (methodology and results)
      and the assessment of the data (?assessor?s comment?).
    • likely from an article but it seems it is concluded by
      the rapporteur; ?According to the author? to be added.
    • Chapters with
      a heading including the word ?conclusion? should include a summary
      of all critical assessment of the assessor for that particular
      chapter.
    • If an assessor?s comment is not needed, the Rapporteur
      should delete the box inserted in the template.
    • ?
      The report should be sufficiently detailed to allow for secondary
      assessment of the available data by other HMPC experts.
    • Overview of available pharmacokinetic data regarding the herbal substance(s), herbal
      preparation(s) and relevant constituents thereof ........................................................... 16

      97
      98

      3.3.

    • Overall conclusions on clinical pharmacology and efficacy ........................................ 27

      Assessment report on
      EMA/HMPC/418902/2005

      Page 4/41

      119

      5.

    • This sections is related to
      available quality standards and there is no need to repeat information
      on all preparations included in the monograph.
    • Search and assessment methodology

      161

      The Rapporteur shall undertake a comprehensive search of relevant
      scientific literature and articles, Acts of law and regulations and
      other relevant sources.

    • Cross-reference to the list of
      references in Annex, which should list separately the references
      supporting the assessment report.
    • 143
      144
      145

      150
      151
      152
      153
      154

      162
      163
      164
      165
      166
      167
      168
      169
      170
      171
      172
      173
      174
      175

      Herbal substance(s)

      Herbal preparation(s)

      Relevant constituents for this assessment report

      Examples of scientific databases to be searched are Medline, PubMed,
      Cochrane Database of Systematic Reviews, EMBASE etc.

    • Assessment report on
      EMA/HMPC/418902/2005

      Page 6/41

      176
      177
      178
      179
      180
      181
      182
      183
      184
      185
      186
      187
      188
      189
      190
      191
      192

      Additional relevant references could also be retrieved from the checked
      references.

    • Examples of books are Hagers Handbuch, The Complete German
      Commission E Monographs, PDR for herbal medicines etc.
    • In addition, information from non-EU regulatory
      authorities for examples Health Canada monographs or WHO monographs
      could be searched, if relevant to herbal substances and preparations in
      EU.
    • 221

      225
      226
      227

      232

      When the assessment report is revised, the rapporteur should briefly
      summarise the main changes under this section.

    • Data are collected using the template entitled ?Document
      for information exchange for the preparation of the assessment report
      for the development of European Union monographs and for inclusion of
      herbal substance(s), preparation(s) or combinations thereof in the
      list? (EMEA/HMPC/137093/2006).
    • Assessment report on
      EMA/HMPC/418902/2005

      Page 8/41

      Herbal substance/

      Indication

      Posology and
      method of

      preparation

      administration

      Posology, age
      groups,
      pharmaceutical
      form, method of
      administration,
      duration of use
      As reported in
      the market
      overview

      As reported in
      the market
      overview

      As reported in
      the market
      overview.

    • Assessment report on
      EMA/HMPC/418902/2005

      Page 10/41

      Herbal substance/

      Indication/Medicinal

      Posology and

      preparation

      use

      method of
      administration

      Posology, age
      groups,
      pharmaceutical
      form, method of
      administration,
      duration of use

      Regulatory Status

      Type of
      regulatory
      status where
      possible, date,
      Country

      287

      This overview is not exhaustive.

    • Clinical Safety/Pharmacovigilance

      836
      837
      838
      839
      840
      841

      See ?Assessment of clinical safety and efficacy in the preparation of
      EU herbal monographs for well-established and traditional herbal
      medicinal products?(EMA/HMPC/104613/2005) for further details.

    • Overall conclusions on clinical safety

      1067

      1068

      In terms of structure, the conclusion should follow the presentation of
      the results above.

    • Overall conclusions

      1092

      1093

      1101

      Describe key aspects only briefly, these will already have been
      described in detail in the respective sections.

    • This section should
      cover all recommended ?well-established use? and ?traditional use?
      indications and conclusions shall be provided for each therapeutic
      indication and each herbal preparation.
    • 1102

      Well established use monograph

      1103
      1104

      The clinical studies supporting well-established use should be
      specified for each therapeutic indication and each herbal preparation.

    • The choice for the wording of traditional use indications vis-?vis existing wordings in monographs in the same therapeutic area should
      be briefly discussed/justified.
    • 1153

      List entry

      1154

      The conclusions should include a statement pointing to the
      possibility/non-possibility to support a European Union list entry.

A new measure of firm-level competition: an application to euro area banks

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Thursday, April 18, 2024
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Abstract

Key Points: 
    • Abstract
      This paper extends Boone (2008) by introducing a competition measure at the individual
      firm level rather than for an entire market segment.
    • We apply this extended Boone indicator to individual bank-level competition
      in the loan market in the four largest euro area countries and Austria.
    • Our new measure of firm-level competition enriches and complements
      other competition measures and provides a promising starting point for future market
      power analyses.
    • The only measure among non-structural measures that is based on the
      concept of competition as a process of rivalry is the Boone (2008) indicator.
    • We introduce
      a new performance measure of competition by extending the Boone indicator to the
      individual firm level.
    • Introduction
      The ability to reliably measure competition is valuable to researchers, analysts, and
      policymakers, especially antitrust authorities, financial supervisors, and central banks.
    • One broad
      category of indicators often used to measure competition are structural competition
      measures, such as static concentration measures, and dynamic measures, e.g., entry and
      exit rates.
    • Out of these measures, the only measure based on the
      concept of competition as a process of rivalry is the Boone indicator.
    • This study introduces a new performance measure of competition by extending the
      Boone indicator to the individual firm level.
    • It thus measures the
      increase in profits in percent of one percentage point increase in efficiency, with marginal
      costs as measure of efficiency.
    • We extend the theoretical
      underpinning of the measurement of competition for the entire market of Boone (2008) by
      a new measure of individual firm-level competition.
    • A concern of the literature is the gap
      between the practical application and the theoretical framework of Boone (2008).
    • We introduce within the same theoretical
      framework a new measure of competition on firm level, the MRP.
    • Our new
      measure significantly augments the antitrust evaluative framework by shedding light on
      whether a merger results in a less competitive market.
    • Our novel indicator focuses on
      firms? incentives to enhance their relative efficiency, as manifested in the elasticity
      between relative profits and efficiency.
    • However, an inefficient firm that is foreclosed could be more
      competitive than the larger efficient firm that relies on its scale economies.
    • Our new metric of competition unveils
      banks? ability to influence their profitability in the short term by cutting costs relative to
      their peers.
    • The new MRP indicator provides the ability to assess the impact
      of individual banks? competitiveness on their interest rate-setting behaviour in loan
      markets.
    • Incorporating this information promises a more refined understanding of the impact and
      timing of monetary policy rates changes on the real economy.
    • Section 3 introduces within the Boone
      (2008) theoretical framework our new measure of individual firm-level competition,
      including the interpretation of the MRP.
    • Section 4 provides an application of our new
      ECB Working Paper Series No 2925

      6

      individual firm-level competition measure to the loan market.

    • The StructureConduct-Performance paradigm (SCP) provides a traditional framework in the field of
      industrial organization for analysing competition behaviour in markets.
    • Concentrated
      markets ease the possibilities to collude implicitly or explicitly and therefore concentrated
      markets result in higher prices and profits.
    • For example, a tougher competition
      setup may lead to a reallocation of market shares, potentially forcing some firms to exit
      the market.
    • This approach gives firms? strategic behaviour
      central stage and focuses on the strategic interaction on prices and quantities, known as
      conjectural variation.
    • Another measure from
      this strand of literature is the H-statistic developed by Panzar and Rosse (1987).
    • The only competition measure from this performance literature where competition is the
      outcome from a process of rivalry is the Boone indicator.
    • A continuous and monotonically increasing relationship exists between
      RPD and the level of competition if firms are ranked by decreasing efficiency.
    • (2013) compare the Boone indicator with the price-cost margin
      and conclude that the profit elasticity is a more reliable measure of competition.
    • The high
      elasticity of profits to efficiency unequivocally indicates that the high market shares and
      therefore high profits are due to high efficiency.
    • A firm that quickly passes changes to the input prices is seen as a price
      taker with little market power.
    • Indicators of competition tend to measure different phenomenon and may provide
      conflicting messages, as reported for European banking by Carbo et al.
    • Application 2: Test the ?quiet life? and related market structure hypotheses using the
      MRP as competition or market structure measure.
    • Data
      Our application to individual bank-level competition in the euro area loan market uses
      balance sheet and income statement data from the Moody?s Analytics BankFocus for the
      calendar years 2013-2020.
    • As such, most publications
      on competition in the euro area includes the largest four member states.
    • Due to these restrictions the database was reduced to an unbalanced panel of up to 1862
      banks (depending on the year) from five euro area countries.
    • Application 1: Measure bank competition using MRP
      Looking at the distribution of the MRP for individual banks (Fig.
    • A similar finding for the four largest euro area countries as a group is
      reported in Carbo et al.
    • Application 2: Test of market structure hypotheses using MRP
      Our new measure of individual-bank competition can be used to test market structure
      theories.
    • Euro area banks? market power,
      lending channel and stability: the effects of negative policy rates, European Central Bank
      Working Paper, 2790 (February).
    • A
      new approach to measuring competition in the loan markets of the euro area, Applied
      Economics, 43 (23), 3155?3167.
    • Impact of bank competition on the interest rate pass-through in the euro area, Applied
      Economics, 45 (11), 1359?1380.

DIGITAL ALLY, INC ANNOUNCES 2023 OPERATING RESULTS

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Tuesday, April 2, 2024
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LENEXA, Kansas, April 02, 2024 (GLOBE NEWSWIRE) -- Digital Ally, Inc. (Nasdaq: DGLY) (the “Company” or “our”), today announced its operating results for fiscal year 2023.

Key Points: 
  • LENEXA, Kansas, April 02, 2024 (GLOBE NEWSWIRE) -- Digital Ally, Inc. (Nasdaq: DGLY) (the “Company” or “our”), today announced its operating results for fiscal year 2023.
  • Operating losses for the year ended December 31, 2023 and 2022 were $22,240,553 and $29,733,258, respectively, a decrease of $7,492,705 (25%).
  • Operating loss as a percentage of revenues improved to 78% in 2023 from 80% in 2022.
  • The Company will host an investor conference call at 11:15 a.m. EDT on Tuesday, April 2, 2023, to discuss its 2023 financial results, corporate and individual subsidiary outlook, and previously announced corporate separation.

Boss Radio 66’s Tom Hanks and Debbie Daughtry Reveal Their Favorite 60s Tracks to Celebrate the Station’s One-Year Anniversary on TuneIn

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Tuesday, March 26, 2024
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To celebrate, the team behind the eclectic 60s music station, Tom Hanks and Producer Debbie Daughtry, revealed their favorite songs from thousands of music tracks in the station library.

Key Points: 
  • To celebrate, the team behind the eclectic 60s music station, Tom Hanks and Producer Debbie Daughtry, revealed their favorite songs from thousands of music tracks in the station library.
  • Launched on TuneIn in March 2023, Boss Radio 66 was founded by Brooklyn Radio Producer Debbie Daughtry as an homage to the 1960s ‘Boss Radio’ format.
  • Huge congratulations to Debbie and Tom on the first anniversary of Boss Radio 66 on TuneIn.
  • To hear more from Daughtry and Hanks, listeners should also check out ‘ Country A-Go-Go ’ on TuneIn.

Global Tactical UAV Industry Research 2023-2033: Integration of Artificial Intelligence (AI) and Rising Geopolitical Tensions and Security Concerns Fueling Developments and Expansion - ResearchAndMarkets.com

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Monday, April 8, 2024
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As technology continues to evolve, these tactical unmanned aerial vehicles (UAVs) play a crucial role in addressing emerging threats and safeguarding national security interests.

Key Points: 
  • As technology continues to evolve, these tactical unmanned aerial vehicles (UAVs) play a crucial role in addressing emerging threats and safeguarding national security interests.
  • The tactical Unmanned Aerial Vehicle (UAV) market is experiencing a transformative surge, presenting a paradigm shift in military and security solutions globally.
  • The global tactical unmanned aerial vehicle (UAV) market based on UAV type is led by fixed wing unmanned aerial vehicle (UAV).
  • Competitive Strategy: Key players in the tactical UAV market analyzed and profiled in the study involve tactical unmanned aerial vehicle (UAV) products offering companies.

JPMorgan Chase Increases Housing Affordability Commitments With Additional $20 Million in Philanthropy and Expanded Customer Offerings

Retrieved on: 
Monday, April 8, 2024
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JPMorgan Chase is increasing its housing affordability commitments across the U.S. with expanded philanthropic capital and consumer lending products.

Key Points: 
  • JPMorgan Chase is increasing its housing affordability commitments across the U.S. with expanded philanthropic capital and consumer lending products.
  • “Healthy communities are integral to our business model, and affordable housing opportunities are vital to creating strong communities and building intergenerational wealth,” said Tim Berry, Global Head of Corporate Responsibility, JPMorgan Chase.
  • “The private sector has an important role to play alongside non-profit organizations and policymakers in advancing housing affordability, including increasing access to homeownership.
  • Delivering Impact with Organizations in Washington, DC and Across the Country
    Today’s philanthropic announcement builds on JPMorgan Chase’s $400 million five-year commitment to improve housing affordability and stability for underserved households.

Yinhawangka People and Rio Tinto partner to co-design ‘Living Cultures Program’

Retrieved on: 
Monday, April 8, 2024
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The Yinhawangka Aboriginal Corporation and Rio Tinto have collaborated to design a new program aimed at protecting and preserving Yinhawangka culture and supporting a strong, healthy and connected Yinhawangka People.

Key Points: 
  • The Yinhawangka Aboriginal Corporation and Rio Tinto have collaborated to design a new program aimed at protecting and preserving Yinhawangka culture and supporting a strong, healthy and connected Yinhawangka People.
  • Rio Tinto will provide $9.5 million to the ‘Living Cultures Program’ over six years.
  • Yinhawangka Aboriginal Corporation Chair, Lorraine Injie said "Firstly, let me acknowledge the hard work and dedication of the Yinhawangka people and Rio Tinto in bringing to life this Living Cultures Project.
  • “I look forward to furthering the close working partnership between Yinhawangka Aboriginal Corporation and Rio Tinto.

Pluxee reinforces Leadership Team to accelerate the execution of its strategic growth

Retrieved on: 
Tuesday, March 19, 2024
American Express, PDD, Travel, Accor, Commercial, Commerce, HEC Paris, Conforama, Edenred, Education, Booking.com, NFC, Operation, Engagement, Country, Chamber of commerce, Coventry University, Gift, Growth, COVID-19, Marketing, Commercial director, IAE, Business travel, Management

Pluxee reinforces Leadership Team to accelerate the execution of its strategic growth.

Key Points: 
  • Pluxee reinforces Leadership Team to accelerate the execution of its strategic growth.
  • To further drive sustainable and profitable growth in key markets, Pluxee is implementing the following changes, effective immediately:
    Thierry Guihard, CEO of Pluxee Brazil, and Malena Gufflet, CEO of Pluxee France, join the Leadership Team.
  • With a strengthened geographic governance in place and a reinforced Leadership Team, the company is ideally positioned to execute its strategic plan and realise the substantial growth opportunity across its key markets.
  • Malena Gufflet has served as Pluxee France CEO since July 2023 and joined the Group Leadership Team in March 2024.

Snoqualmie Casino announces their New Country Roundup event

Retrieved on: 
Monday, March 18, 2024
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SEATTLE, March 18, 2024 (GLOBE NEWSWIRE) -- Snoqualmie Casino is thrilled to unveil its latest marquee event, the New Country Roundup, scheduled for Saturday, April 20th, 2024.

Key Points: 
  • SEATTLE, March 18, 2024 (GLOBE NEWSWIRE) -- Snoqualmie Casino is thrilled to unveil its latest marquee event, the New Country Roundup, scheduled for Saturday, April 20th, 2024.
  • This premiere event spotlights the diverse sounds shaping modern country music, headlined by notable artists Karen Waldrup, Antwane Tyler, Avery Anna and Jackson Snelling.
  • The New Country Roundup at Snoqualmie Casino is more than just a concert; it's a celebration of the genre's evolution and the bright future ahead.
  • For more information and to purchase tickets, please visit the Snoqualmie Casino website or contact the box office directly.

Pharvaris Announces Phase 3 Clinical Study Design for Recently Initiated RAPIDe-3 Study, and Presents Quality-of-Life Improvement and Caregiver Behavior Data at Two Recent HAE Congresses

Retrieved on: 
Monday, March 18, 2024
Angioedema, Conference, EOP, Attack, Quality of life (healthcare), Network, Safety, HAE, Hereditary angioedema, Patient, Adolescence, Heredity, Country, National Congress, Physician, Medicine, Pharmaceutical industry

“We are committed to the continued advancement of our clinical development program of deucrictibant to fulfill unmet needs of current HAE treatment,” said Berndt Modig, Chief Executive Officer of Pharvaris.

Key Points: 
  • “We are committed to the continued advancement of our clinical development program of deucrictibant to fulfill unmet needs of current HAE treatment,” said Berndt Modig, Chief Executive Officer of Pharvaris.
  • The RAPIDe-3 study is designed to assess the effectiveness of deucrictibant in addressing that unmet need.
  • RAPIDe-3 is a randomized, double-blind, placebo-controlled, crossover study, which is designed to enroll approximately 120 adolescent and adult participants globally.
  • The data illustrates that HRQoL is negatively impacted, including functional and psychological impairment, in people with HAE.