Syringe

EQS-News: Gerresheimer decisively continues on profitable growth course in financial year 2023

Retrieved on: 
Wednesday, March 13, 2024

Organic revenue growth in 2023: +10.4%

Key Points: 
  • Organic revenue growth in 2023: +10.4%
    Organic adjusted EBITDA growth in 2023: +17.5%
    Düsseldorf, February 22, 2024.
  • Gerresheimer, an innovative system and solution provider and a global partner for the pharma, biotech and cosmetic industries, decisively continued on its profitable growth course in the financial year 2023 with an organic revenue growth of 10.4% and a strong adjusted EBITDA growth of 17.5%.
  • “Our strong results in 2023 underpin Gerresheimer’s successful transformation as part of our formula g strategy process,” says Dietmar Siemssen, CEO of Gerresheimer AG.
  • In view of the positive development of the operating business, the high order backlog and the current expansion of production capacities, Gerresheimer continues to expect profitable growth in the years ahead.

EQS-News: SCHOTT Pharma reports good start into fiscal year 2024

Retrieved on: 
Wednesday, March 13, 2024

Q1 2024 revenues of EUR 232m; increase of 8% yoy at constant currencies

Key Points: 
  • Q1 2024 revenues of EUR 232m; increase of 8% yoy at constant currencies
    SCHOTT Pharma, a pioneer in pharma drug containment solutions and delivery systems, had a good start into the fiscal year 20241.
  • On this basis, we are embarking on another successful year for SCHOTT Pharma,” said Andreas Reisse, CEO of SCHOTT Pharma.
  • In the first quarter of 2024, SCHOTT Pharma achieved several milestones along its strategy of innovation and expansion, demonstrating its commitment to growth.
  • The most important pharma trends that SCHOTT Pharma meets with its products will continue to serve as growth drivers for the company.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Catalent, Inc. - CTLT

Retrieved on: 
Thursday, March 7, 2024

NEW YORK, March 07, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Catalent, Inc. (“Catalent” or the “Company”) (NYSE: CTLT).

Key Points: 
  • NEW YORK, March 07, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Catalent, Inc. (“Catalent” or the “Company”) (NYSE: CTLT).
  • The investigation concerns whether Catalent and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • As part of the transaction, Novo Nordisk will acquire three Catalent manufacturing facilities, including a plant located in Bloomington, Indiana.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

Sharps Technology and Roncadelle Operations Sign Worldwide Sales and Distribution Agreement for their Innovative Portfolio of Safe Technology Drug Delivery Systems

Retrieved on: 
Thursday, March 7, 2024

The agreement, signed on March 4, 2024, lays the groundwork for further collaboration between Sharps and Roncadelle to develop and manufacture next-generation drug delivery products.

Key Points: 
  • The agreement, signed on March 4, 2024, lays the groundwork for further collaboration between Sharps and Roncadelle to develop and manufacture next-generation drug delivery products.
  • “We believe that this is just the beginning of Sharps’ collaboration with Roncadelle.
  • “This alliance underscores our unwavering commitment to innovation and excellence, reshaping standards within the global healthcare landscape.”
    Sharps Technology specializes in the development and manufacturing of innovative drug delivery systems.
  • As part of the cooperative agreement, Sharps and Roncadelle intend to collaborate on the development of new drug delivery products.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Catalent, Inc. - CTLT

Retrieved on: 
Wednesday, February 28, 2024

NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Catalent, Inc. (“Catalent” or the “Company”) (NYSE: CTLT).

Key Points: 
  • NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Catalent, Inc. (“Catalent” or the “Company”) (NYSE: CTLT).
  • The investigation concerns whether Catalent and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • As part of the transaction, Novo Nordisk will acquire three Catalent manufacturing facilities, including a plant located in Bloomington, Indiana.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Catalent, Inc. - CTLT

Retrieved on: 
Tuesday, February 20, 2024

NEW YORK, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Catalent, Inc. (“Catalent” or the “Company”) (NASDAQ: CTLT).

Key Points: 
  • NEW YORK, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Catalent, Inc. (“Catalent” or the “Company”) (NASDAQ: CTLT).
  • The investigation concerns whether Catalent and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • As part of the transaction, Novo Nordisk will acquire three Catalent manufacturing facilities, including a plant located in Bloomington, Indiana.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

Stevanato Group Delivers Double-Digit Revenue Growth in Fiscal Year 2023

Retrieved on: 
Thursday, March 7, 2024

Revenue for the fourth quarter of 2023 increased 10% to €320.6 million, and high-value solutions represented 37% of total revenue.

Key Points: 
  • Revenue for the fourth quarter of 2023 increased 10% to €320.6 million, and high-value solutions represented 37% of total revenue.
  • For fiscal year 2023, revenue increased 10% to €1,085.4 million, and high-value solutions represented 34% of total revenue.
  • Excluding revenue contributions from Covid-19, revenue grew approximately 24% in the fourth quarter of 2023, compared with the same period in 2022.
  • Revenue from high-value solutions increased to 34% of total revenue for fiscal year 2023, compared with 30% last year.

Argonaut Manufacturing Services Expands Aseptic Pharmaceutical Fill / Finish Capabilities with $45 Million Equity Investment from NewVale Capital and Telegraph Hill Partners

Retrieved on: 
Tuesday, March 5, 2024

Argonaut Manufacturing Services (“Argonaut”), a leading contract development and manufacturing organization serving the biopharma and life sciences industries, announced today the completion of a $45 million financing to support its new drug product fill / finish expansion.

Key Points: 
  • Argonaut Manufacturing Services (“Argonaut”), a leading contract development and manufacturing organization serving the biopharma and life sciences industries, announced today the completion of a $45 million financing to support its new drug product fill / finish expansion.
  • Argonaut expects to have fully validated the facility and all equipment in 2025.
  • The financing was led by NewVale Capital, a growth equity fund focused on innovative pharmaceutical and life science services businesses, with participation from existing majority investor Telegraph Hill Partners, and other current investors.
  • “For years, small- and medium-sized biopharma companies have struggled to find reliable, high-quality fill / finish capabilities from providers that prioritize their molecules.

Global Insulin Pen Market Report 2024: A $14.1 Billion Forecasted Market by 2028, Registering Compound Annual Growth Rate of 6% - ResearchAndMarkets.com

Retrieved on: 
Wednesday, February 28, 2024

The global insulin pen market was valued at $9.9 billion in 2022.

Key Points: 
  • The global insulin pen market was valued at $9.9 billion in 2022.
  • The market is expected to grow at a compound annual growth rate (CAGR) of 6.1%, reaching $14.1 billion by the end of 2028.
  • In 2022, the reusable insulin pen segment held the highest market share at about 51.5%, followed by disposable pens at 48.5%.
  • This report thoroughly examines the worldwide market size of global insulin pen delivery technology, enhancing its appeal to stakeholders and readers alike.

Compilation of quality review of documents (QRD) on stylistic matters in product information

Retrieved on: 
Sunday, March 10, 2024

29 February 2024

Key Points: 
    • 29 February 2024
      EMA/25090/2002 rev.23*
      Human Medicines Division

      Compilation of QRD decisions on stylistic matters in product information
      Issues
      Abbreviations

      Connected problems
      Subscript and superscript

      QRD Suggestions
      Acronyms must be written in their standard form; e.g.

    • Cmax, Cmax
      Abbreviations and

      Not always understood,

      Non-standard abbreviations and acronyms should be avoided, and the term should be written out in full.

    • The same applies when stating the pharmaceutical form in section 3 of the SmPC and section 4 of the labelling;
      i.e.
    • critical steps prior to administration of the product should also be included (section 5 of Annex IIIA).
    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 2/23

      Issues

      Connected problems

      QRD Suggestions

      emphasise in the labelling
      the special handling prior
      to administration of the
      product.

    • Consistency

      Inconsistencies in style are

      Once a particular style or house style has been selected, it must be used consistently throughout the text.

    • Tradename 150 mg solution for injection in pre-filled syringe
      Tradename 150 mg solution for injection in pre-filled pen

      information annexes?

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 3/23

      Issues
      Desiccant

      Connected problems

      QRD Suggestions

      For medicinal products

      The foil of blister packs containing a desiccant must be clearly labelled to show which blister pocket contains

      packaged with a desiccant

      the desiccant.

    • For bottles containing a desiccant, a similar statement should also be considered provided there

      mistake the desiccant for a

      is available space.

    • It can only be included in brackets in section 3 of the

      where can this be

      SmPC and section 4 of the labelling.

    • Direct speech should only
      be used in section 6 of the SmPC for instructions about shelf-life, storage, handling and disposal.
    • The term ?drug? though can be used in the product information annexes when it is part of a standard set of
      terms (e.g.
    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 5/23

      Issues
      Foreign terms

      Connected problems

      QRD Suggestions

      Foreign terms, particularly

      Foreign terms must be written in italics; e.g.

    • Patients can be referred to as ?he? or

      physician is often referred

      as ?she? when the medicinal product is exclusively for use by males or females.

    • if the product in question might be

      measurements are

      used by elderly patients), in brackets after the metric measures in the English text.

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 6/23

      Issues

      Connected problems

      QRD Suggestions

      product name is composed
      of MAH+INN?

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 7/23

      Issues

      Connected problems

      QRD Suggestions
      MT: English
      BG: Bulgarian
      NL: Dutch
      CZ: Czech or English at applicant?s discretion.

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 14/23

      Issues

      Connected problems

      QRD Suggestions
      considered, e.g.

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 16/23

      Issues
      Symbols: Non-Unicode

      Connected problems

      QRD Suggestions

      The use of non-Unicode

      Only Unicode symbols must be used in submitted product information annexes.

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 20/23

      Issues

      Connected problems

      Units: SI base units -

      International Standard

      litre

      base units have been
      introduced in the European
      Union with Council
      Directive 80/181/EEC of
      20.12.79 (O.J.

    • Compilation of QRD decisions on stylistic matters in product information
      EMA/25090/2002

      Page 23/23