Radiopharmaceutical

ITM, Helmholtz Munich and University Hospital Münster Announce First Patient Dosed in Phase I Investigator-Initiated Glioblastoma Trial

Retrieved on: 
Mardi, avril 23, 2024
Patient, Safety, Hospital, Research, Glioblastoma, Disease, Radiopharmaceutical, Teaching hospital, IIT, ITM, Nuclear medicine, Injection, Pharmaceutical industry

Garching/Munich, Munich and Münster, April 23, 2024 – The Departments of Neurosurgery and Nuclear Medicine at the University Hospital Münster, Helmholtz Munich, and ITM Isotope Technologies Munich SE (ITM) , a leading radiopharmaceutical biotech company, today announced that the first patient has been dosed in an investigator-initiated trial (IIT) with ITM’s radiopharmaceutical drug candidate, ITM-31 for the potential use in glioblastoma patients.

Key Points: 
  • Garching/Munich, Munich and Münster, April 23, 2024 – The Departments of Neurosurgery and Nuclear Medicine at the University Hospital Münster, Helmholtz Munich, and ITM Isotope Technologies Munich SE (ITM) , a leading radiopharmaceutical biotech company, today announced that the first patient has been dosed in an investigator-initiated trial (IIT) with ITM’s radiopharmaceutical drug candidate, ITM-31 for the potential use in glioblastoma patients.
  • The IIT is sponsored by the University Hospital Münster, conducted in hospitals in Münster, Essen, Cologne, and Würzburg, and supported by Helmholtz Munich and ITM.
  • After glioblastoma patients receive standard treatment with surgery, radio- and chemotherapy, individual tumor cells often remain undetected in surrounding tissue and grow again leading to relapse.
  • Patients will receive their personalized calculated total doses of ITM-31 in three fractions with an interval of 4 weeks between injections.

TLX101-CDx (Pixclara™) Granted FDA Fast Track Designation

Retrieved on: 
Lundi, avril 15, 2024
FDA, University, Fast Track, Pharmacy, Food and Drug Administration, TLX, NDA, Food, Radiology, MD, ASX, PET, Partnership, Research, Glioma, UCSF, Patient, FET, Radiopharmaceutical, 18F-FET, Diagnosis

MELBOURNE, Australia, April 16, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has granted Fast Track designation1 for the Company’s investigational glioma imaging product, TLX101-CDx (Pixclara™2, 18F-floretyrosine or 18F-FET).

Key Points: 
  • MELBOURNE, Australia, April 16, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has granted Fast Track designation1 for the Company’s investigational glioma imaging product, TLX101-CDx (Pixclara™2, 18F-floretyrosine or 18F-FET).
  • The granted Fast Track designation is for the characterisation of progressive or recurrent glioma using positron emission tomography (PET).
  • Concurrently, Telix is in the final stages of preparing its U.S. New Drug Application (NDA) for TLX101-CDx in this initial indication, in both adult and paediatric patients.
  • This designation enables expedited review and closer consultation with the FDA during the review process.

Mariana Oncology to be Acquired by Novartis to Advance Precision Radiopharmaceuticals to Treat Cancer

Retrieved on: 
Jeudi, mai 2, 2024
Biotechnology, Health, Radiology, Pharmaceutical, Oncology, Cancer, RLT, Atlas, Atlas Venture, Doctor of Philosophy, Centerview Partners, Research, Carcinoma, Biomedicine, Science, Biomedical Research, Acquisition, Radiopharmaceutical, Drug discovery, Medical imaging

The acquisition brings together Mariana Oncology’s innovative radiopharmaceutical pipeline and platform with the proven clinical development and commercialization expertise of Novartis.

Key Points: 
  • The acquisition brings together Mariana Oncology’s innovative radiopharmaceutical pipeline and platform with the proven clinical development and commercialization expertise of Novartis.
  • “Novartis is an established leader in the commercialization of radiopharmaceuticals with a world-class team and global reach.
  • Together, we offer a compelling combination of capabilities,” said Simon Read, Founder and CEO, Mariana Oncology.
  • Centerview Partners LLC served as financial advisor, and Goodwin Procter as legal counsel to Mariana Oncology on the transaction.

ASP Isotopes Issues Letter to Stockholders

Retrieved on: 
Jeudi, avril 11, 2024
Consensus, FDA, Nuclear energy, Uranium, Memorandum, Void coefficient, SMR, Intelligence, Prostate cancer, Isotope, ASP, Silicon, Annual report, Yoy, PET, Semiconductor, Private, DOE, Acceleration, Safety, GE HealthCare, Small modular reactor, Artificial intelligence, Coal, Nuclear Energy Institute, Exercise, Isotopes of ytterbium, NEI, Cyclotron, Laser, Radiopharmaceutical, Government, FDG, Silane, Sale, Lithium, Lutetium (177Lu) vipivotide tetraxetan, LEU, Lutetium, Radionuclide, Electronics, ASPI, Letter, Growth, Rare-earth element

WASHINGTON, April 11, 2024 (GLOBE NEWSWIRE) -- ASP Isotopes Inc. NASDAQ: ASPI ("ASPI,” or the “Company”), an advanced materials company dedicated to the development of technology and processes designed to produce isotopes used in multiple industries, today released the following letter to stockholders from its Chairman and CEO, Paul Mann.

Key Points: 
  • WASHINGTON, April 11, 2024 (GLOBE NEWSWIRE) -- ASP Isotopes Inc. NASDAQ: ASPI ("ASPI,” or the “Company”), an advanced materials company dedicated to the development of technology and processes designed to produce isotopes used in multiple industries, today released the following letter to stockholders from its Chairman and CEO, Paul Mann.
  • The contract required RC14 to provide an irrevocable standby letter of credit in lieu of a deposit, which was received.
  • Our proprietary technology has proven capabilities to enrich a wide range of isotopes, including light isotopes and lighter molecules, such as silane (SiH4).
  • ASP Isotopes’ goal is to become the lowest cost and most reliable supplier of stable isotopes globally.

NorthStar Appoints Peter Pfreundschuh to Board of Managers

Retrieved on: 
Lundi, avril 15, 2024
Research, Other Health, Biotechnology, Radiology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, CFO, Cancer, LLP, NorthStar, Johnson & Johnson, Business development, Health technology, Business, Growth, CDMO, Rider University, Sucampo Pharmaceuticals, Patient, SCMP, Radiopharmaceutical, MBA, Therapy, Ernst & Young, Certified Public Accountant, AstraZeneca, Pharmaceutical industry

NorthStar Medical Technologies, LLC, parent company of NorthStar Medical Radioisotopes, LLC, a global innovator in development, production and commercialization of radiopharmaceuticals used to detect and treat cancer and other serious diseases, today announced the appointment of Peter (Pete) Pfreundschuh to its Board of Managers, effective April 1, 2024.

Key Points: 
  • NorthStar Medical Technologies, LLC, parent company of NorthStar Medical Radioisotopes, LLC, a global innovator in development, production and commercialization of radiopharmaceuticals used to detect and treat cancer and other serious diseases, today announced the appointment of Peter (Pete) Pfreundschuh to its Board of Managers, effective April 1, 2024.
  • "We are pleased to welcome Pete to the NorthStar Board," said Stephen Merrick, Executive Chairman of NorthStar.
  • “2024 and the next few years will be critical for NorthStar,” said Frank Scholz, NorthStar President and Chief Executive Officer.
  • I look forward to Pete joining the NorthStar Board.”

NorthStar Medical Radioisotopes, LLC Enters Clinical Supply Agreement to Support Clarity Cu-67 SAR-bisPSMA Pivotal Trials

Retrieved on: 
Mercredi, avril 10, 2024
Research, Clinical Trials, Biotechnology, Radiology, Health, Pharmaceutical, Other Science, Science, Oncology, Radiopharmaceutical, CDMO, Prostate cancer, Cancer, Clinical trial, Patient, Olaf Scholz, Calendar, NorthStar, Pharmaceutical industry

NorthStar Medical Radioisotopes, LLC, a global innovator in development, production and commercialization of radiopharmaceuticals used to detect and treat cancer and other serious diseases, today announced the signing of a Clinical Supply Agreement with Clarity Pharmaceuticals for the production of 67Cu-SAR-bisPSMA drug product for Clarity’s Phase I/II and Phase III trials.

Key Points: 
  • NorthStar Medical Radioisotopes, LLC, a global innovator in development, production and commercialization of radiopharmaceuticals used to detect and treat cancer and other serious diseases, today announced the signing of a Clinical Supply Agreement with Clarity Pharmaceuticals for the production of 67Cu-SAR-bisPSMA drug product for Clarity’s Phase I/II and Phase III trials.
  • The overarching Master Service agreement and associated Clinical Supply Agreement are effective immediately and the initial production of supply to support Clarity trials is expected to occur before the end of calendar 2024.
  • “Given Clarity’s outstanding clinical trial data to date, NorthStar is very excited to play a pivotal role in securing the supply of Cu-67 and final drug product for the trials with 67Cu-SAR-bisPSMA in prostate cancer,” said Frank Scholz, President and Chief Executive Officer of NorthStar.
  • “We are building out our contract development and manufacturing (CDMO) capabilities so that the biopharma innovators like Clarity can focus on discovering the next breakthrough.

PharmaLogic announces opening of new state-of-the-art radiopharmaceutical production facility in Cincinnati

Retrieved on: 
Lundi, avril 22, 2024
Radiopharmaceutical, CDMO, BOCA, Patient, Cancer, Research, Pharmaceutical industry

BOCA RATON, Fla., April 22, 2024 /PRNewswire/ -- PharmaLogic Holdings Corp., ("PharmaLogic" or "the company"), a world-class contract development and manufacturing organization (CDMO) and radiopharmacy solutions provider, announced the opening of its new radiopharmaceutical production and research facility in Cincinnati, Ohio.

Key Points: 
  • BOCA RATON, Fla., April 22, 2024 /PRNewswire/ -- PharmaLogic Holdings Corp., ("PharmaLogic" or "the company"), a world-class contract development and manufacturing organization (CDMO) and radiopharmacy solutions provider, announced the opening of its new radiopharmaceutical production and research facility in Cincinnati, Ohio.
  • The state-of-the-art facility signifies a leap forward in PharmaLogic's mission to deliver life-saving diagnostic and therapeutic radiopharmaceuticals to patients across North America.
  • "After years of meticulous planning and construction, we're thrilled to unveil our advanced facility in Cincinnati," said D. Scott Holbrook, Chief Strategy Officer and General Manager of PharmaLogic.
  • "The impact of this facility extends far beyond expanding access to innovative radiopharmaceuticals for the greater Cincinnati community.

EQS-News: Eckert & Ziegler Continues on Growth Path after Successful Financial Year 2023

Retrieved on: 
Mercredi, avril 10, 2024
Radiopharmaceutical, Medicine, TecDAX

Berlin, March 22, 2024 - Eckert & Ziegler SE (ISIN DE0005659700, TecDAX) generated sales of € 246.1 million in the 2023 financial year.

Key Points: 
  • Berlin, March 22, 2024 - Eckert & Ziegler SE (ISIN DE0005659700, TecDAX) generated sales of € 246.1 million in the 2023 financial year.
  • In the Medical segment, sales rose by € 24.3 million or 27% to € 115.2 million compared to the previous year.
  • At € 130.9 million, sales in the Isotope Products segment remained at the previous year's level (€ 131.4 million).
  • For the 2024 financial year, the Executive Board expects sales of just under € 265 million and EBIT before special items from continuing operations of around € 50 million.

Curium Plans to Significantly Expand Lutetium-177 Capacity and Pet Footprint With Agreement to Acquire Eczacibaşi-Monrol

Retrieved on: 
Lundi, avril 8, 2024
Party, Partnership, Patient, PET, Acquisition, Radiopharmaceutical, MENA, SPECT, Nuclear medicine, Medical imaging

PARIS, April 08, 2024 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today that it has entered into an agreement with Eczacıbaşı Holding and Bozlu Group for the acquisition of Eczacıbaşı-Monrol Nuclear Product Co. (Monrol), a dedicated specialist in nuclear medicine. The acquisition is expected to bring together highly complementary geographical footprints, lutetium-177 (Lu-177) capabilities, and PET & SPECT nuclear medicine infrastructure, as well as facilitate the development of cutting-edge radionuclides and radiopharmaceuticals pipelines for diagnostic and therapeutic purposes.

Key Points: 
  • It will expand Curium’s PET footprint of 34 sites in Western Europe and Asia with the addition of 12 owned and partnered sites in Eastern Europe and MENA regions.
  • In addition, Eczacıbaşı-Monrol’s manufacturing and logistics infrastructure in Istanbul, Turkey, will add significant scale to Curium’s vertically integrated production and distribution capabilities.
  • Eczacıbaşı Holding and Curium are fully committed to navigating through this process efficiently and expect to finalize the transaction in due course.
  • The Parties expect to be able to close this transaction once the customary regulatory approvals will have been obtained.

Perspective Therapeutics to Participate at Upcoming April Investor Conferences

Retrieved on: 
Lundi, avril 8, 2024
Jefferies, Cancer, Conference, CATX, Radiopharmaceutical

SEATTLE, April 08, 2024 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. (“Perspective” or “the Company”) (NYSE AMERICAN: CATX), a radiopharmaceutical company that is pioneering advanced treatment applications for cancers throughout the body, today announced it will participate in two investor conferences in April.

Key Points: 
  • SEATTLE, April 08, 2024 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. (“Perspective” or “the Company”) (NYSE AMERICAN: CATX), a radiopharmaceutical company that is pioneering advanced treatment applications for cancers throughout the body, today announced it will participate in two investor conferences in April.
  • Thijs Spoor, Chief Executive Officer, will be participating in a panel discussion titled Radiopharmaceuticals: Energizing Disruption in Therapeutics, at the Goldman Sachs Third Annual Healthruption Conference, on April 9, 2024 at 2:40 p.m.
  • Management will be available for one-on-one investor meetings at the conference.
  • A replay of the Jefferies presentation will be archived for 90 days and available through the Investors page on the Perspective website.