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Industry News

RadioMedix and Curium Announce FDA Filing of copper Cu 64 dotatate injection New Drug Application

(Houston, TX and St. Louis, MO – January 7, 2020) - RadioMedix Inc. and its commercial partner Curium announced today that the New Drug Application for copper Cu 64 dotatate injection was filed with the U.S. Food and Drug Administration (FDA). Copper Cu 64 dotatate injection is a PET diagnostic agent intended for somatostatin receptor (SSTR) expressing neuroendocrine tumors (NETs). The FDA previously granted Fast Track designation to copper Cu 64 dotatate injection.

“If approved, we expect that copper Cu 64 dotatate injection will be the first FDA approved Cu 64 labeled radiopharmaceutical for PET/CT imaging. In addition, this drug will provide an exciting new imaging agent for NET physicians, patients and caregivers,” said Ebrahim Delpassand, MD, CEO of RadioMedix. “Copper Cu 64 dotatate injection will be the first neuroendocrine PET diagnostic agent available to all medical centers with PET capability across the country. This will alleviate the scheduling and supply challenges many geographies have experienced with other somatostatin analogue PET agents. We are currently pursuing a Priority Review with the FDA to expedite commercial availability.”

“If approved, the clinical utility of this new agent will allow Curium to enhance patient care in the U.S. by bringing the accuracy of PET SSTR to all hospitals and imaging centers,” said Curium CEO, North America, Dan Brague. “Our ability to manufacture copper Cu 64 dotatate injection at a central location and distribute quantities to meet the needs of hospitals and imaging centers demonstrates our continued focus on patients with neuroendocrine tumors. We are excited to be bringing Cu 64, an exciting new isotope for PET imaging, to the market. We look forward to exploring additional applications that can help patients and physicians.”

About RadioMedix
RadioMedix, Inc. is a clinical stage biotechnology company, based in Houston, Texas, focused on innovative targeted radiopharmaceuticals for diagnosis, monitoring, and therapy of cancer. The company is commercializing radiopharmaceuticals for PET imaging and therapeutic (alpha and beta-labeled) radiopharmaceuticals. RadioMedix has also established contract service facilities for academic and industrial partners: Full cGMP manufacturing and analytical suites for human clinical trials, and commercial phase manufacturing of the radiopharmaceuticals, in addition to small animal Molecular Imaging Center for the pre-clinical evaluation of new targets in vitro and in vivo. To learn more, visit www.radiomedix.com. For more information about this press release, please contact:media@radiomedix.com

About Curium
Curium is a world-class nuclear medicine solutions provider with more than a century of industry experience. Curium is the largest vertically integrated radiopharmaceutical product manufacturer in the industry.

With manufacturing facilities across Europe and the United States, Curium supports over 14 million patients around the world with SPECT, PET, and therapeutic radiopharmaceuticals. The Curium brand name is inspired by the work of radiation researchers Marie and Pierre Curie and emphasizes a focus on nuclear medicine. To learn more, visit curiumpharma.com. For more information about this press release, please contact Janet Ryan media contact for Curium: janet@ryan-pr.com

About Neuroendocrine Tumors
Neuroendocrine tumors (NETs) are a heterogeneous group of rare neoplasms that originate from neuroendocrine cells. These neoplasms occur mostly in the gastrointestinal tract and pancreas, but can also occur in other tissues including thymus, lung, and other uncommon sites such as cervix, heart and prostate. Most NETs strongly express somatostatin receptors (SSTRs).



07.01.2020

Curium Acquires Finnish Radiopharmaceuticals Company
MAP Medical Technologies Oy

(London and Paris – December 02, 2019) — Curium has successfully completed the acquisition of Finnish radiopharmaceuticals company MAP Medical Technologies Oy. The acquisition of MAP Medical will further expand Curium’s footprint in Europe, providing direct access to Nordic and Baltic countries for its broad portfolio of life saving diagnostic solutions.

MAP Medical operates three GMP manufacturing sites across Finland, two in Helsinki and one in Tikkakoski, and has been supplying critical radiopharmaceutical agents to customers across Nordics and Baltics since 1991. The Company employs c.50 people and offers a range of PET diagnostic agents. It is also a distributor of Curium’s SPECT product portfolio in Finland.

“We are looking forward to integrating MAP Medical into our network of 25 PET sites across Europe” says Benoit Woessmer, CEO of PET EUROPE at Curium. “This acquisition complements our current geographical footprint and enables us to offer our broad range of products and future pipeline of innovative agents to customers and patients across Nordics and Baltics.”

“The MAP Medical team is excited to be part of a global nuclear medicine platform” commented Mika Nyyssönen and Jarmo Haukka, co-founders of MAP Medical. “We are confident that, in Curium, they have found the right home to further build their careers in this exciting field, developing and commercializing lifesaving diagnostic and therapeutic solutions to patients globally”.

About Curium
Curium is a world-class nuclear medicine solutions provider with more than a century of industry experience. Curium is the largest vertically integrated radiopharmaceutical product manufacturer in the industry.

With manufacturing facilities across Europe and the United States, Curium supports over 14 million patients around the world with SPECT, PET, and therapeutic radiopharmaceuticals. The Curium brand name is inspired by the work of radiation researchers Marie and Pierre Curie and emphasizes a focus on nuclear medicine. To learn more, visit curiumpharma.com. For more information about this press release, please contact Janet Ryan media contact for Curium:janet@ryan-pr.com.


About MAP Medical Technologies Oy
MAP Medical Technologies Oy, founded in 1991, is an independent Finnish company focused on developing and manufacturing radiopharmaceuticals which improve the quality and length of human life as well as serve the needs of nuclear medicine professionals. The company operates three facilities in Finland and distributes a broad range of PET and SPECT products to customers across Nordics and Baltics.



02.12.2019

Hermes Medical Solutions receives 510(k) FDA clearance for Voxel Dosimetry

Hermes Medical Solutions has received 510(k) FDA clearance for its Voxel DosimetryTM product. The product has previously been CE-marked.

Voxel DosimetryTM provides estimates (deterministic) of absorbed radiation dose at voxel level as a result of administrating one of the supported radionuclides and providing a 3-dimensional dose map.

Hermes Medical Solutions´ Voxel DosimetryTM supports the 7 most common isotopes; Ga68, I123, I131, In111, Lu177, Tc99m and Y90.

The Voxel DosimetryTM workflow consists of the following steps:
• SPECT/CT or PET/CT DICOM data loading from the data manager (e.g. PACS)
• Registration of different time-points to a common reference study
• Generation and integration of voxel-level time-activity curves
• Voxel-level absorbed dose calculation using a Monte Carlo method
• Saving of the absorbed dose map back to the data manager (e.g. PACS) in DICOM format

“This is an important step towards the holy grail in medical imaging, Theranostics”, says Hermes Medical Solutions´ CEO Tom Francke. “Voxel DosimetryTM is the most advanced dosimetry product on the market, which was also recognized by the FDA. It supports all the most commonly used isotopes. It is now both CE-marked and FDA-approved”.


Further reading: https://www.hermesmedical.com/products/oncology-dosimetry-olinda-theranostics/

Hippeläinen ET, Tenhunen MJ, Mäenpää HO, Heikkonen JJ, Sohlberg AO. Dosimetry software Hermes Internal Radiation Dosimetry: from quantitative image reconstruction to voxel-level absorbed dose distribution. Nuclear Medicine Communications 2017; 38:5:357-365 Gustafsson J, Brolin G, Cox M, Ljungberg M, Johansson L, Gleisner KS. Uncertainty propagation for SPECT/CT-based renal dosimetry in Lu-177 peptide receptor radionuclide therapy. Phys Med Biol. 2015;60(21):8329–8346

Contact:
Tom Francke, info@hermesmedical.com

21.10.2019

Curium Announces Revised Pricing for Technescan MAG3TM (kit for the preparation of technetium Tc 99m mertiatide)

(St. Louis, MO – September 4, 2019) – Curium announced today that it is implementing a new pricing model for Technescan MAG3. Curium is phasing out its pay per dose sales model, in which Curium supplies a vial of Technescan MAG3 to a nuclear pharmacy and the nuclear pharmacy pays Curium a designated price for each dose that it compounds and dispenses to its customers. Curium is transitioning to a price per vial approach. The average price per vial currently being established is approximately $625 for most U.S. customers. This change provides a simplified approach that customers tell us will benefit their operations.

“After careful review of our sales approach, we are making this change to simplify the tracking and reporting demands of our customers and provide them a clearer picture of their supply costs,” said Curium CEO, North America, Dan Brague. “The transition will likely take several months to implement but will be a focal point for our sales team during the second half of 2019. We look forward to partnering with our customers on this new approach and continuing to learn how we can better serve their needs.”

About Curium
Curium is a world-class nuclear medicine solutions provider with more than a century of industry experience. Curium is the largest vertically integrated radiopharmaceutical product manufacturer in the industry.
With manufacturing facilities across Europe and the United States, Curium supports over 14 million patients around the world with SPECT, PET, and therapeutic radiopharmaceuticals. The Curium brand name is inspired by the work of radiation researchers Marie and Pierre Curie and emphasizes a focus on nuclear medicine. To learn more, visit curiumpharma.com. For more information about this press release, please contact Janet Ryan media contact for Curium: janet@ryan-pr.com


04.09.2019

Serac Imaging Systems to develop a compact, hybrid optical/gamma camera which will be portable, smaller, easier to use and more cost effective than anything that exists on the market today

Please find below and attached a press release announcing the formation of a new molecular imaging company, Serac Imaging Systems, which has been established to develop a highly innovative, miniature, hybrid gamma/optical camera (HGC) which will be portable, cheaper, smaller and easier to use than anything that exists on the market today. The IP for the HGC has been exclusively licensed from a group of universities led by the University of Leicester.

SIS Press Release

27.06.2019

Theranostics: New hope for late stage prostate cancer patients with an innovative UK-first treatment

Dr Yong Du, Clinical Director Theranostics; Julie Martin, Business Development Theranostics; Emma Spellman Head of Theranostics and Imaging UK and Dan McGowan, Research Physicist – Nuclear Medicine.

The first patients in the UK have now received an innovative theranostics treatment for advanced prostate cancer at GenesisCare, giving new hope for men who have exhausted other treatment options. The UK’s largest private cancer care provider, GenesisCare, announced today that the service is now available at its centre in Windsor for the first time in the UK.

Press Release

03.06.2019

Blue Earth press release

Blue Earth Diagnostics continues to expand access to Axumin (fluciclovine (18F)) in Europe

Blue Earth Diagnostics continues to expand

09.05.2019

Blue Earth Diagnostics’ latest press release

Announcing the addition of Axumin® (fluciclovine (18F)) to the EAU guidelines for imaging in patients with biochemical recurrence in Prostate Cancer.

The aim of the EAU Guidelines is to assist practicing clinicians in making informed decisions in a given circumstance; taking the highest quality scientific data, their patient’s personal circumstances, values and preferences into account. This is great news for BED as it’s a clear recognition of the clinical value of Axumin in Europe.

Press Release

17.04.2019

Blue Earth Diagnostics celebrates 5 year anniversary

Press Release - Blue Earth Diagnostics celebrates five years

Press Release

06.03.2019

Blue Earth Diagnostics’ Latest Press Release

Blue Earth Diagnostics’ latest press release announcing the first production and administration of Axumin® (fluciclovine (18F)) in Italy. This news demonstrates our continued commitment to maximize access to Axumin across Europe.

Press Release

12.02.2019

Brexit Update From Curium - Updated

Please find the most recent information surrounding our Brexit contingency plans

Feb 2019 Curium Brexit Contigency updated

18.02.2019    

 

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