Radiopharmaceutical

Draft revised consolidated 3-year work plan for the Methodology Working Party (MWP)

Retrieved on: 
Wednesday, February 14, 2024

Industry level .................................................................................................. 13

Key Points: 
    • Industry level .................................................................................................. 13

      Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      1.

    • A reflection paper
      (RP) on the clinical pharmacology package for oligonucleotides is a prioritised activity in the MWP work

      Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      plan, and it is envisaged that something similar may be needed for other emerging treatment
      modalities (e.g., peptides).

    • Guideline work led by other working parties
      ?

      Revision of the guideline on the requirements for clinical documentation for orally inhaled
      products (CPMP/EWP/4151/00 Rev.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      The planned concept papers (CPs) will formulate problem statements for potential workshops and
      subsequent guidance documents will be informed and enriched by the outcome of discussions of
      workshops to be held in 2024.

    • Guideline work led by other working parties and committees
      ?

      Revision of Guidance on the investigation of medicinal products in the term and preterm
      neonate (EMEA/536810/2008).

    • There is a need for
      Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      new guidance in these areas to ensure these novel approaches meet the required evidentiary
      standards and facilitate their evaluation.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      ?

      Revision of Guideline on clinical evaluation of diagnostic agents (CPMP/EWP/1119/98/Rev.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      ?

      Provide appropriate support to the EU network for generic and hybrid medicines including
      product-specific requirements.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      2.3.

    • ?

      Cross disciplinary work with Quality Working Party and other stakeholders on physiologically
      based biopharmaceutics modelling (PBBM).

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      ?

      In order to support adequate evaluation of all methodology MWP will aim to facilitate an
      increase in presence and visibility in relevant committees of methodological expertise from
      across the EU network such as CHMP, PRAC, PDCO, CMD(h), ETF and CAT.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      ?

      Product Specific Bioequivalence Guidelines (PSBGLs) (multiple) in liaison with CMD(h): for
      2024, azacitidine, budesonide (LALA GIT), trametinib, dabrafenib, paliperidone palmitate (3M
      depot) and melatonin have been prioritised as the next in series for drafting.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      4.2.

    • ?

      Cross disciplinary work with Quality Working Party and other stakeholders on PBBM model
      assessment.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      ?

      To deliver an improved access to raw data (e.g.

    • ?

      Propose regulatory research priorities for funders in across the activities of Methodology
      Working Party, including in the big data area.

    • ?

      Establish key communication points in national competent authorities and build a resource of
      key messages and communication materials on regulation and methodology.

    • The timing of workshops may need to be arranged according to the

      Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      specific needs of the guidance ? either before the guidance is finalised to gather views and
      expertise; or once it is finalised for training purposes.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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Curasight announces acceleration of therapeutic strategy to strengthen position as a radiopharmaceutical theranostic company

Retrieved on: 
Tuesday, February 13, 2024

COPENHAGEN, Denmark, Feb. 13, 2024 /PRNewswire/ -- Curasight A/S ("Curasight" or the "Company" (XSAT: CURAS) announces today that it is accelerating and expanding its clinical therapeutic strategy with the addition of a new Phase I/IIa trial to include a total of five cancer indications in a so called basket trial design.

Key Points: 
  • COPENHAGEN, Denmark, Feb. 13, 2024 /PRNewswire/ -- Curasight A/S ("Curasight" or the "Company" (XSAT: CURAS) announces today that it is accelerating and expanding its clinical therapeutic strategy with the addition of a new Phase I/IIa trial to include a total of five cancer indications in a so called basket trial design.
  • To strengthen the Company's capital structure and secure funding for the acceleration of clinical activities, Curasight intends to launch a rights issue during the first quarter of 2024.
  • By launching this basket trial, we can accelerate development of both uTRACE and uTREAT (theranostic) in parallel and potentially have therapeutic efficacy data already during 2025.
  • Under the terms of the deal, Curasight is responsible for development until regulatory approval with Curium responsible for manufacturing and commercialisation.

Curasight announces acceleration of therapeutic strategy to strengthen position as a radiopharmaceutical theranostic company

Retrieved on: 
Tuesday, February 13, 2024

COPENHAGEN, Denmark, Feb. 13, 2024 /PRNewswire/ -- Curasight A/S ("Curasight" or the "Company" (XSAT: CURAS) announces today that it is accelerating and expanding its clinical therapeutic strategy with the addition of a new Phase I/IIa trial to include a total of five cancer indications in a so called basket trial design.

Key Points: 
  • COPENHAGEN, Denmark, Feb. 13, 2024 /PRNewswire/ -- Curasight A/S ("Curasight" or the "Company" (XSAT: CURAS) announces today that it is accelerating and expanding its clinical therapeutic strategy with the addition of a new Phase I/IIa trial to include a total of five cancer indications in a so called basket trial design.
  • To strengthen the Company's capital structure and secure funding for the acceleration of clinical activities, Curasight intends to launch a rights issue during the first quarter of 2024.
  • By launching this basket trial, we can accelerate development of both uTRACE and uTREAT (theranostic) in parallel and potentially have therapeutic efficacy data already during 2025.
  • Under the terms of the deal, Curasight is responsible for development until regulatory approval with Curium responsible for manufacturing and commercialisation.

Telix Signs Agreement to Acquire QSAM Biosciences and Its Bone Cancer Targeting Platform

Retrieved on: 
Wednesday, February 7, 2024

MELBOURNE, Australia, Feb. 08, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces it has entered into an agreement to acquire QSAM Biosciences, Inc. (U.S. OTC: QSAM) and its lead investigational drug Samarium-153-DOTMP (153Sm-DOTMP).

Key Points: 
  • MELBOURNE, Australia, Feb. 08, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces it has entered into an agreement to acquire QSAM Biosciences, Inc. (U.S. OTC: QSAM) and its lead investigational drug Samarium-153-DOTMP (153Sm-DOTMP).
  • QSAM is a United States (U.S.) based company developing therapeutic radiopharmaceuticals for primary and metastatic bone cancer.
  • Telix believes that 153Sm-DOTMP may benefit patients with metastatic lung and breast cancer, where many patients develop brain and bone metastases, and disease management often focusses on quality-of-life palliative care.
  • Telix will issue ordinary shares to the stockholders of QSAM at closing within its Listing Rule 7.1 placement capacity as consideration for the acquisition.

QSAM Biosciences Signs Definitive Agreement to be Acquired by Telix Pharmaceuticals

Retrieved on: 
Wednesday, February 7, 2024

Austin, TX, Feb. 07, 2024 (GLOBE NEWSWIRE) -- QSAM Biosciences Inc. (OTCQB: QSAM) (“QSAM or the “Company”) has signed a definitive Agreement and Plan of Merger (the “Agreement”) providing for the acquisition of the Company by Telix Pharmaceuticals Limited (ASX: TLX) (“Telix”).

Key Points: 
  • Austin, TX, Feb. 07, 2024 (GLOBE NEWSWIRE) -- QSAM Biosciences Inc. (OTCQB: QSAM) (“QSAM or the “Company”) has signed a definitive Agreement and Plan of Merger (the “Agreement”) providing for the acquisition of the Company by Telix Pharmaceuticals Limited (ASX: TLX) (“Telix”).
  • Prior to closing the merger, QSAM will effect a reverse stock split of its common stock in a ratio between 1:1000 and 1:2000.
  • Each whole share of QSAM common stock outstanding after the reverse split will receive Telix Shares.
  • All QSAM stockholders will receive one CVR for each QSAM common share held prior to the reverse split.

ATS Reports Third Quarter Fiscal 2024 Results

Retrieved on: 
Wednesday, February 7, 2024

In the fourth quarter of fiscal 2024, management expects the conversion of Order Backlog to revenues to be in the 36% to 39% range.

Key Points: 
  • In the fourth quarter of fiscal 2024, management expects the conversion of Order Backlog to revenues to be in the 36% to 39% range.
  • In the third quarter of fiscal 2024, restructuring expenses of $16.2 million were recorded in relation to the reorganization.
  • The majority of the remaining actions are expected to be completed during the fourth quarter of fiscal 2024.
  • ATS will host a conference call and webcast at 8:30 a.m. eastern on Wednesday, February 7, 2024 to discuss its quarterly results.

EQS-News: Eckert & Ziegler to Supply Nucleus Radiopharma with Therapeutic Radioisotopes Ac-225 and Lu-177

Retrieved on: 
Monday, February 5, 2024

Berlin, Germany and Rochester, MN, USA – January 31, 2024 – Eckert & Ziegler (ISIN DE0005659700, SDAX) and Nucleus Radiopharma (Nucleus) signed extensive supply agreements for major therapeutic radioisotopes.

Key Points: 
  • Berlin, Germany and Rochester, MN, USA – January 31, 2024 – Eckert & Ziegler (ISIN DE0005659700, SDAX) and Nucleus Radiopharma (Nucleus) signed extensive supply agreements for major therapeutic radioisotopes.
  • Eckert & Ziegler will serve as core supplier for high-quality Lutetium-177 (Lu-177) as well as Actinium-225 (Ac-225), both in non-carrier-added form.
  • Nucleus will use the radioisotopes to complement and advance their services for clinical development and manufacturing of radiopharmaceuticals.
  • "We are pleased to support Nucleus’ activities with our Actinium-225 and Lutetium-177 supply and thus contribute to the advancement of radiotherapies,” stated Dr. Harald Hasselmann, CEO of Eckert & Ziegler.

ITM and Alpha-9 Oncology Announce Global Supply Agreement to Support Alpha-9’s Clinical Radiopharmaceutical Development Program

Retrieved on: 
Tuesday, January 30, 2024

GARCHING / MUNICH, Germany and VANCOUVER, British Columbia, January 30, 2024 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and Alpha-9 Oncology (Alpha-9) , a clinical stage biotechnology company developing differentiated and highly targeted radiopharmaceuticals, today announced the signature of a global master clinical supply agreement to support the development of Alpha-9’s Radiopharmaceutical Therapy (RPT) pipeline candidates for the treatment of cancer.

Key Points: 
  • GARCHING / MUNICH, Germany and VANCOUVER, British Columbia, January 30, 2024 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and Alpha-9 Oncology (Alpha-9) , a clinical stage biotechnology company developing differentiated and highly targeted radiopharmaceuticals, today announced the signature of a global master clinical supply agreement to support the development of Alpha-9’s Radiopharmaceutical Therapy (RPT) pipeline candidates for the treatment of cancer.
  • Under the terms of the agreement, ITM will supply its medical radioisotope, non-carrier-added Lutetium-177 (n.c.a.
  • 177Lu for the clinical development of Alpha-9 radiopharmaceutical candidates comprising n.c.a.
  • ITM holds a U.S. Drug Master File (DMF) with the Food and Drug Administration (FDA) for n.c.a.

Eckert & Ziegler to Supply Nucleus RadioPharma with Therapeutic Radioisotopes Ac-225 and Lu-177

Retrieved on: 
Wednesday, January 31, 2024

Eckert & Ziegler (ISIN DE0005659700, SDAX) and Nucleus RadioPharma (Nucleus) signed extensive supply agreements for major therapeutic radioisotopes.

Key Points: 
  • Eckert & Ziegler (ISIN DE0005659700, SDAX) and Nucleus RadioPharma (Nucleus) signed extensive supply agreements for major therapeutic radioisotopes.
  • Eckert & Ziegler will serve as core supplier for high-quality Lutetium-177 (Lu-177) as well as Actinium-225 (Ac-225), both in non-carrier-added form.
  • Nucleus will use the radioisotopes to complement and advance their services for clinical development and manufacturing of radiopharmaceuticals.
  • "We are pleased to support Nucleus’ activities with our Actinium-225 and Lutetium-177 supply, and thus contribute to the advancement of radiotherapies,” stated Dr. Harald Hasselmann, CEO of Eckert & Ziegler.

Blue Earth Diagnostics Highlights Clinical Utility of POSLUMA® (Flotufolastat F 18) PET and Post-scan Changes in Management in Patients with Suspected Recurrence of Prostate Cancer at ASCO GU

Retrieved on: 
Thursday, January 25, 2024

The sub-analysis assessed the impact of POSLUMA on treatment plans for patients with recurrent prostate cancer after curative-intent primary therapy.

Key Points: 
  • The sub-analysis assessed the impact of POSLUMA on treatment plans for patients with recurrent prostate cancer after curative-intent primary therapy.
  • View the full release here: https://www.businesswire.com/news/home/20240125625091/en/
    POSLUMA® (flotufolastat F 18) PET/CT image showing uptake in the prostate bed, consistent with recurrent prostate cancer.
  • Photo courtesy of Blue Earth Diagnostics
    Flotufolastat F 18 PET imaging was positive for recurrent prostate cancer in 84% (81/97) of patients in the sub-analysis.
  • In 89% (86/97) of patients, management plans were changed following review of the flotufolastat F 18 PET scan results.