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Industry News

Helapet Updates Syringe/Endcap Integrity Testing for Compliant Preparation of Injectable Medicines

Syringe Caps & Pharmapack® Press release

Helapet have announced that is has conducted new physical and microbiological integrity closure testing on their PharmaPack® range of sterile multi-pack BD syringes, in combination with a select range of syringe endcaps. The updated testing improves on existing compliances based on the recommended guidelines set down by the Pharmaceutical Aseptic Services Group (PASG) in their 2013 Yellow Document on the Protocols for the Integrity Testing of Syringes.

Following the release of the 2013 Yellow Document it is now necessary for NHS Aseptic Production Units (APU’s) to assess the integrity of the applied syringe/endcap combinations when preparing injectable medicines. Using both microbiological and physical integrity testing, a comprehensive assessment of the luer-lock closure can be made and evidence used to approve the use of that syringe/endcap combination for the sterile preparation of patient medications.

Two test methodologies were undertaken by a commissioned NHS Laboratory, involving a suitable number of test samples of syringe/endcap combinations subjected to microbiological and physical integrity testing. The microbial integrity evaluation involved sterile filling each sample, which was then challenged by immersion in a culture of Brevundimonas Diminuta and incubated at 30-35°C for 14 consecutive days. Physical integrity testing involved the samples being subjected to a dye intrusion test to determine whether any dye appeared to have entered the syringe barrel whilst under conditions matching those used for patient products.

The results concluded that the selected syringe/endcap combinations demonstrated the suitable durability required to pass both integrity tests, delivering compliant syringe closure and secure protection against physical leakages and external microbial contamination.

About Helapet

Helapet has been a respected supplier to the NHS for over 30 years, supplying sterile single-use consumable products to meet the high standards and requirements of healthcare professionals working in aseptic working environments.

Helapet is a member of the respected CliniMed® (Holdings) Group, comprising of eight specialist companies dedicated to supporting patient care through the supply of vital products into the healthcare industry.

Further reading:

https://www.helapet.co.uk/downloads/Integrity_Testing_of_Syringes_2013_2nd_Edn.pdf
NHS Method: Protocols for the Integrity Testing of Devices; 2nd Edition, revised April 2013

https://www.helapet.co.uk/downloads/29098_PharmaPack_Integrity_Testing_Summary_Datasheet.pdf
PharmaPack® Sterile Multi-Pack Syringe/Endcap Integrity Test Summary, 2019

 

Contact:
Chris Steng info@helapet.co.uk



07.04.2020

Curium Announces Approval of Pulmotech™ MAA (kit for the preparation of technetium Tc 99m albumin aggregated injection) by the U.S. Food and Drug Administration

(St. Louis, MO – March 24, 2020)- Curium announced today that the U.S. Food and Drug Administration (FDA) has approved Pulmotech MAA. When labeled to technetium Tc 99m, Pulmotech MAA is a single-photon emission agent for lung imaging as an adjunct in the evaluation of pulmonary perfusion and, in adults, to aid in the evaluation of peritoneovenous shunt patency. Curium has marketed a similar version of MAA (macroaggregated albumin) in Europe for more than a decade and expects to begin selling product to U.S. customers in April 2020.

“We are excited to bring Pulmotech MAA to the market,” said Dan Brague, Curium CEO, North America. “Our customers have been asking us to expand our product portfolio to include an MAA product for several years. I am happy to share that we have listened and we are now able to help supply the needs of clinicians and their patients. This is the first in a series of anticipated approvals over the next two years in which Curium will bring solutions to the market.”

“I am excited to bring a second MAA product to the U.S. market and look forward to engaging with customers on Pulmotech MAA immediately. This brand offers our customers significant value and is a tremendous addition to our growing portfolio of products in the U.S.” said Andy Farrow, VP of Sales, North America.

 

About Pulmotech MAA

Curium offers customers the flexibility to purchase vials in either a pack of 5 or in a box of 30. To order any product in Curium’s portfolio, please contact Customer Service at 1-888-744-1414.

 

Indication

Technetium Tc 99m Albumin Aggregated Injection is a radioactive diagnostic agent indicated for:

  • Lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients.
  • Scintigraphy of peritoneovenous shunt as an aid in the evaluation of its patency in adults.

 

IMPORTANT RISK INFORMATION

Contraindications

  • Patients with severe pulmonary hypertension
  • Persons with a history of hypersensitivity reactions to products containing human serum albumin

 

Warnings and Precautions

  • Serious adverse reactions have been reported in patients with pulmonary hypertension
  • Serious hypersensitivity reactions have been reported

 

Adverse Reactions

  • Deaths after administration to patients with severe pulmonary hypertension and serious hypersensitivity reactions have been reported.

 

Use In Specific Populations

  • Lactation: Temporarily discontinue breastfeeding and discard breast milk for 13 hours after administration.

 

Please see Full Prescribing Information at https://www.curiumpharma.com/pulmotech-maa

 

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



24.03.2020

RadioMedix and Curium Announce copper Cu 64 dotatate injection Was Granted Priority Review by the U.S. FDA

(Houston, TX and St. Louis, MO – March 11, 2020) - RadioMedix Inc. and its commercial partner Curium announced the U.S. Food and Drug Administration (FDA) has granted copper Cu 64 dotatate injection a priority review. Copper Cu 64 dotatate is a PET diagnostic agent intended for somatostatin receptor (SSTR) expressing neuroendocrine tumors (NETs). Curium is preparing to launch copper Cu 64 dotatate in Q3 of this year.

“If approved, we expect that copper Cu 64 dotatate injection will have a significant impact on physicians, neuroendocrine tumor patients and their caregivers as this will help alleviate the scheduling and supply challenges many geographies have experienced with other somatostatin analogue PET agents,” said Ebrahim Delpassand, MD, CEO of RadioMedix.

“We are preparing for the full-scale commercialization of copper Cu 64 dotatate injection and are excited to introduce a new product and a new isotope into the market. We are pleased that our significant efforts will result in helping neuroendocrine tumor patients receive a specific, sensitive and timely diagnosis,” said Curium CEO, North America, Dan Brague.

About RadioMedix

RadioMedix, Inc. is a clinical-stage biotechnology company, based in Texas, focused on innovative targeted radiopharmaceuticals for diagnosis, monitoring, and therapy of cancer. The company is commercializing radiopharmaceuticals for PET imaging and targeted alpha and beta-emitter therapy. RadioMedix has research and contract service facilities for academic and industrial partners: the cGMP Dose Manufacturing and Analytical suites for the investigational clinical trials, and the Drug Discovery and Pre-clinical Core Facility for pre-clinical evaluation of drugs, both located in Houston, TX. Also, a second new state of art commercial manufacturing facility located in Humble, TX, has been recently established. To learn more, visit wwww.radiomedix.com. For more information about this press release, please contact:media@radiomedix.com. Follow us on social media: LinkedIn https://www.linkedin.com/company/radiomedix-inc-/ Facebook: https://www.facebook.com/RadioMedix-Inc/

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).



12.03.2020

Vent-Medis High Volume Crucible

Xiel Ltd have been requested to cease all commercial activities with the Vent-Medis High Volume Crucible whist the MHRA legal team review if the product can be registered as both a pharmaceutical and medical device. Please see more details in the attached letter.

As communicated in the attached letter and should you wish, we are offering to accept the return of all products sold since 19.11.19 for a full refund. Please confirm if this is an option you wish to explore and we will arrange collection of your Purchase order 200726889 at a convenient time, and issue a full credit against our invoice 253 dated 17.12.19.

Please note that Xiel can continue to offer Servicing and Maintenance of Technegas Generators which are not impacted by the current MHRA request.

Xiel ltd apologise for any inconvenience caused but can assure you we are working with the correct authorities to have this resolved as soon as possible and as soon as more information is received we will of course keep you updated.



23.01.2020

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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