Bracco

Philochem and Blue Earth Diagnostics Announce First Three Patients Imaged in Phase 1 Clinical Trial of 68Ga-OncoFAP (68Ga-OncoFAP-DOTAGA) for Diagnostic Imaging in Solid Tumors

Retrieved on: 
Monday, December 4, 2023

The collaboration encompasses the development of OncoFAP, a proprietary, small organic ligand with ultra-high affinity to Fibroblast Activation Protein (FAP), for applications in the diagnostic imaging of solid tumors.

Key Points: 
  • The collaboration encompasses the development of OncoFAP, a proprietary, small organic ligand with ultra-high affinity to Fibroblast Activation Protein (FAP), for applications in the diagnostic imaging of solid tumors.
  • Under the agreement, the Philogen Group is conducting a Phase 1 clinical study to evaluate the safety and dosimetry of 68Ga-OncoFAP (68Ga-OncoFAP-DOTAGA) in patients with solid tumors.
  • The agreement provides Blue Earth Diagnostics rights to develop and commercialize 68Ga-OncoFAP worldwide.
  • The first three enrolled patients in the trial were imaged in November 2023 at the National Cancer Institute of Milan (INT).

Cumulus Neuroscience Receives FDA 510(k) Clearance for Award-Winning, First-In-Class Neurophysiology Platform for At-Home Use

Retrieved on: 
Thursday, May 4, 2023

BELFAST, Northern Ireland and CAMBRIDGE, Mass., May 4, 2023 /PRNewswire/ -- Cumulus Neuroscience (Cumulus; The Company), a global digital health company focused on advancing neuroscience clinical trials and patient care through improved data, today announced that its novel, award-winning dry-sensor EEG headset, has been granted 510(k) clearance from the United States Food and Drug Administration (FDA). This represents the second medical device clearance for the headset, which previously received the UK Conformity Assessed (UKCA) mark in the United Kingdom.  

Key Points: 
  • This represents the second medical device clearance for the headset, which previously received the UK Conformity Assessed (UKCA) mark in the United Kingdom.
  • This groundbreaking technology provides a means to initiate clinical studies remotely with data transmitted to the Cumulus Medical Device Hub, allowing healthcare professionals to review EEG recordings in real-time.
  • The company's 510(k) clearance comes on the heels of its appointment of Tina Sampath as Chief Commercial Officer (CCO).
  • Cumulus supports precision in CNS clinical trials for its industry partners by enabling remote monitoring of patients across multiple domains of brain function.

Cumulus Neuroscience Receives FDA 510(k) Clearance for Award-Winning, First-In-Class Neurophysiology Platform for At-Home Use

Retrieved on: 
Thursday, May 4, 2023

BELFAST, Northern Ireland and CAMBRIDGE, Mass., May 4, 2023 /PRNewswire/ -- Cumulus Neuroscience (Cumulus; The Company), a global digital health company focused on advancing neuroscience clinical trials and patient care through improved data, today announced that its novel, award-winning dry-sensor EEG headset, has been granted 510(k) clearance from the United States Food and Drug Administration (FDA). This represents the second medical device clearance for the headset, which previously received the UK Conformity Assessed (UKCA) mark in the United Kingdom.  

Key Points: 
  • This represents the second medical device clearance for the headset, which previously received the UK Conformity Assessed (UKCA) mark in the United Kingdom.
  • This groundbreaking technology provides a means to initiate clinical studies remotely with data transmitted to the Cumulus Medical Device Hub, allowing healthcare professionals to review EEG recordings in real-time.
  • The company's 510(k) clearance comes on the heels of its appointment of Tina Sampath as Chief Commercial Officer (CCO).
  • Cumulus supports precision in CNS clinical trials for its industry partners by enabling remote monitoring of patients across multiple domains of brain function.

Blue Earth Therapeutics Awarded UK MHRA Innovation Passport for Investigational 177Lu-rhPSMA-10.1 for Treatment of Metastatic Castrate-Resistant Prostate Cancer (mCRPC)

Retrieved on: 
Tuesday, November 8, 2022

Blue Earth Therapeutics, a Bracco company and emerging leader in the development of innovative next generation therapeutic radiopharmaceuticals, today announced that its investigational therapeutic radiopharmaceutical, 177Lu-rhPSMA-10.1, has been awarded an Innovation Passport for the treatment of metastatic castrate-resistant prostate cancer.

Key Points: 
  • Blue Earth Therapeutics, a Bracco company and emerging leader in the development of innovative next generation therapeutic radiopharmaceuticals, today announced that its investigational therapeutic radiopharmaceutical, 177Lu-rhPSMA-10.1, has been awarded an Innovation Passport for the treatment of metastatic castrate-resistant prostate cancer.
  • Blue Earth Therapeutics and Blue Earth Diagnostics work closely on the development of 177Lu-rhPSMA-10.1.
  • Blue Earth Therapeutics has an emerging pipeline, initially focused on prostate cancer, and with plans to expand into additional disease areas in oncology.
  • In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting-edge biotechnology vehicle to develop radiopharmaceutical therapies.

Bracco Elevates Next Generation of Radiologists, Announces Recipients of the 2022 "Leaders on the Horizon" Residency Program

Retrieved on: 
Wednesday, November 9, 2022

MONROE TOWNSHIP, N.J., Nov. 9, 2022 /PRNewswire/ -- Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., an innovative world leader in diagnostic imaging, announced today the 2022 "Leaders on the Horizon" Residency Program recipients.

Key Points: 
  • The "Leaders on the Horizon" Residency Program champions the next generation of radiology leaders.
  • The program is a key component of Bracco's ongoing commitment to advancing knowledge, leadership, and education in radiology.
  • "We are proud to support the 'Leaders on the Horizon' Residency Program," said Cosimo De Pinto, Senior Vice President of Sales and Marketing at Bracco.
  • In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting-edge biotechnology dedicated to advancing next generation targeted radiotherapeutics to treat patients who have cancer.

Bracco Imaging SpA and BDP International Achieve Pharma Transportation ‘First’

Retrieved on: 
Friday, June 17, 2022

Milan, Italy and Philadelphia, PA, June 17, 2022 (GLOBE NEWSWIRE) -- Bracco Imaging SpA (Bracco), an international leader in all modalities of diagnostic imaging solutions, and BDP International (BDP, a member of the PSA Group), a leading provider of globally integrated supply chain, transportation and logistics solutions, have successfully completed a first-of-its-kind move for the Bracco Group.

Key Points: 
  • Milan, Italy and Philadelphia, PA, June 17, 2022 (GLOBE NEWSWIRE) -- Bracco Imaging SpA (Bracco), an international leader in all modalities of diagnostic imaging solutions, and BDP International (BDP, a member of the PSA Group), a leading provider of globally integrated supply chain, transportation and logistics solutions, have successfully completed a first-of-its-kind move for the Bracco Group.
  • For Bracco, sustainability is an integral component of our mission and day-to-day operations, noted Maurizio Zanetti, Logistics Manager Bracco SpA.
  • Bracco Imaging S.p.A. ("Bracco Imaging"), part of the Bracco Group, is an innovative world leader delivering end-to-end products and solutions through its comprehensive portfolio across diagnostic imaging modalities.
  • Bracco Imaging portfolio includes products and solutions for all key diagnostic imaging modalities: X-ray imaging, magnetic resonance imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine.

Blue Earth Therapeutics Announces U.S. FDA Clearance for Investigational New Drug (IND) Application for 177Lu-rhPSMA-10.1 for Treatment of Prostate Cancer

Retrieved on: 
Tuesday, April 12, 2022

177Lu-rhPSMA-10.1 is the first clinical candidate in Blue Earth Therapeutics oncology development program of next generation therapeutic radiopharmaceuticals.

Key Points: 
  • 177Lu-rhPSMA-10.1 is the first clinical candidate in Blue Earth Therapeutics oncology development program of next generation therapeutic radiopharmaceuticals.
  • Blue Earth Therapeutics holds exclusive worldwide rights to therapeutic applications of radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) radiopharmaceutical technology to help advance the treatment of patients with prostate cancer.
  • Blue Earth Therapeutics has an emerging pipeline, initially focused on prostate cancer, and with plans to expand into additional disease areas in oncology.
  • In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting-edge biotechnology vehicle to develop radiopharmaceutical therapies.

Bracco Celebrates Personalized and Precision Medicine Innovations at RSNA 2021

Retrieved on: 
Monday, October 18, 2021

MONROE TOWNSHIP, N.J., Oct. 18, 2021 /PRNewswire/ -- Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, today announces diagnostic imaging, contrast media and informatics achievements that are propelling personalized and precision medicine forward while demonstrating understanding of the community's needs today.

Key Points: 
  • MONROE TOWNSHIP, N.J., Oct. 18, 2021 /PRNewswire/ -- Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, today announces diagnostic imaging, contrast media and informatics achievements that are propelling personalized and precision medicine forward while demonstrating understanding of the community's needs today.
  • Innovations will be featured at the Bracco booth (#1129 South Hall Level 3) during the Radiological Society of North America (RSNA) Annual Meeting being held November 28 to December 2.
  • Bracco Imaging S.p.A., part of the Bracco Group, is a world-leading diagnostic imaging provider, headquartered in Milan, Italy.
  • Bracco Imaging has a strong presence in key geographies: North America, China, Europe, Japan, Brazil, Mexico and South Korea.

Blue Earth Diagnostics Announces Axumin® (Fluciclovine F 18) Presentations at Upcoming Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting

Retrieved on: 
Tuesday, June 8, 2021

Blue Earth Diagnostics also has a Medical Affairs information booth at SNMMI, where attendees can learn about ongoing clinical trials.

Key Points: 
  • Blue Earth Diagnostics also has a Medical Affairs information booth at SNMMI, where attendees can learn about ongoing clinical trials.
  • A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence.
  • Formed in 2014, Blue Earth Diagnostics is led by proven experts in nuclear medicine, who have expanded and advanced its robust oncology portfolio.
  • In 2019 Bracco Imaging also enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics.

AI-for-COVID19: Predictive Diagnostics Platform Available to Global Scientific Community

Retrieved on: 
Monday, May 17, 2021

This valuable tool enables the international scientific community to share radiological and clinical data and find innovative solutions to combat the disease.

Key Points: 
  • This valuable tool enables the international scientific community to share radiological and clinical data and find innovative solutions to combat the disease.
  • The AIforCOVID Imaging Archive, which is available, open access to the global scientific community at https://aiforcovid.radiomica.it/ , contains more than a thousand positive patient chest radiographic examinations carried out upon hospitalization.
  • The AIforCOVID Imaging Archive platform is another step in this sharing process.
  • Bracco Imaging has a strong presence in key geographies: North America, China, Europe, Japan, Brazil, Mexico and South Korea.\nTo learn more about Bracco Imaging, visit www.braccoimaging.com .\n'