Successful Industry Collaboration Leads to Another Collective Victory: WMIS Launches Clinical Trials for Sodium Fluoride for CMS
Trial is critical for PET reimbursement
November 30, 2011
Herndon, Va. (PRWEB) November 30, 2011 - With the success of the World Molecular Imaging Society's (WMIS) initiative in helping obtain the FDA approval for Sodium Fluoride F18 injection, WMIS is now launching critical clinical trials to secure fair and meaningful reimbursement for this procedure. Successful clinical trials for reimbursement are necessary to ensure the feasibility and market acceptance for this diagnostic test.
Siemens PETNET Solutions Signs Nationwide Commercial Agreement to Manufacture and Distribute Lilly's Molecular Imaging Agent
Siemens subsidiary to manufacture and distribute molecular imaging agent currently under FDA review
November 7, 2011
Malvern, Pa., and Knoxville, Tenn., November 7, 2011 - PETNET Solutions Inc., a wholly owned subsidiary of Siemens Medical Solutions USA, Inc., has entered into a nationwide commercial agreement with Eli Lilly and Company that grants Siemens PETNET Solutions the right to manufacture and distribute Lilly's molecular imaging agent that is currently under review by the U.S. Food and Drug Administration (FDA) for positron emission tomography (PET) imaging.
Siemens PETNET Solutions Opens University of Va. Imaging Biomarker Manufacturing and Nuclear Pharmacy Facility
October 14, 2011
Knoxville, Tenn., Oct. 14, 2011 - PETNET Solutions Inc., a wholly owned subsidiary of Siemens Medical Solutions USA, Inc., has expanded its positron emission tomography (PET) services in the Virginia/Maryland area with the September 8 opening of its cyclotron-equipped manufacturing facility and PET nuclear pharmacy on the University of Virginia (UVA) campus in Charlottesville. The new facility, which PETNET Solutions operates in conjunction with UVA, will provide radiopharmaceuticals for oncology, cardiology and neurology.
New partnership to create research and commercial manufacturing hub at UC Davis in Sacramento
October 11, 2011
Sacramento, Calif., Oct. 11, 2011 - UC Davis Health System, PETNET Solutions Inc., a wholly owned subsidiary of Siemens Medical Solutions USA, Inc., and Northern California PET Imaging Center (NCPIC) announced today that they will partner to establish a facility on the university's Sacramento campus for research and training in radiochemistry and for the commercial production of radiopharmaceutical products used in positron emission tomography (PET) scans -- an imaging technique that provides molecular information important for diagnosing disease and conducting clinical research.
Siemens Completes Phase II Trial for PET Biomarker
Continuing the fight against cancer, Siemens researches an oncology imaging biomarker designed to facilitate imaging of hypoxic tumor regions
September 28, 2011
Malvern, Pa., Sept. 28, 2011 - The Molecular Imaging Biomarker Research Group of Siemens Medical Solutions USA, Inc., recently completed a Phase II multi-center clinical trial of its HX4 positron emission tomography (PET) imaging biomarker, which is designed to detect hypoxia - a reduction in tissue oxygen levels - in solid tumors. The trial's primary objective was to test the reproducibility of HX4's uptake in tumors by conducting PET/computed tomography (CT) scans of the same patient on sequential days in a test-retest protocol. The trial enrolled 40 patients with head and neck, lung, liver, rectal or cervical cancers, who were scheduled to receive chemotherapy, radiation therapy or a combination of the two.
PETNET Solutions Assists NCI/NIH in Facilitating FDA Approval for Their NDA for Sodium Fluoride F18 Injection
February 8, 2011
Knoxville, Tenn., February 8, 2011 - In an announcement by the National Cancer Institute (NCI) and the National Institutes of Health (NIH), the U.S. Food and Drug Administration (FDA) has approved a New Drug Application for use of a new strength of a previously approved drug, sodium fluoride F 18 (18F-NaF) injection, for use in bone scans. PETNET Solutions, Inc. a wholly-owned subsidiary of Siemens Medical Solutions USA, Inc. is the only commercial manufacturer to be included in this NDA for 18F-NaF injection, at this time.
PETNET Solutions Announces Imaging Biomarker Production Capabilities in Madrid
October 11, 2010
Knoxville, Tenn., October 11, 2010 - As part of its global expansion, Siemens PETNET Solutions, Spain Operations announced today the opening of its newest imaging biomarker production facility in Madrid, Spain.
Siemens PETNET Solutions Expands Imaging Biomarker Production Capabilities in the UK
October 8, 2010
Knoxville, Tenn., October 8, 2010 - Siemens PETNET Solutions; A Division of Siemens PLC, announced today the expansion of its imaging biomarker production capabilities in Nottingham, England to include the ability to produce new biomarkers as investigational medicine products (IMP) in the United Kingdom. These IMPs include a proprietary hypoxic agent developed by Siemens for identification of tumor tissues with low oxygen supply, and a leading investigational amyloid agent, for PET imaging of ß-amyloid deposits in the brain.
PETNET Solutions Announces Domestic and International Expansion at SNM 2010
54 production facilities serve a global market: U.S., U.K., Korea, Spain, Australia; more on the way
June 6, 2010
Salt Lake City, Utah, June 6, 2010 - PETNET Solutions (booth #1235), a wholly owned subsidiary of Siemens Medical Solutions USA, Inc., announces the expansion of its PET radiopharmaceutical network internationally and in the United States. Already a leader in the production and delivery of PET imaging biomarkers in the U.S., the United Kingdom and South Korea, PETNET added three production and distribution facilities worldwide. PETNET has expanded to Albuquerque, N.M.; Madrid, Spain; and Sydney, Australia. Further international expansion will build a PETNET presence in France, Singapore and India - completing the first phase of international expansion and contributing to a truly global footprint.
Avid Radiopharmaceuticals and Siemens PETNET Solutions Collaborate on Manufacturing of β-Amyloid Imaging Agent, Florbetapir F 18 (18F-AV-45)
April 7, 2010
Philadelphia, PA and Knoxville, TN - April 7, 2010 - Avid Radiopharmaceuticals, Inc. ("Avid") and PETNET Solutions, Inc. ("PETNET"), a wholly-owned subsidiary of Siemens Medical Solutions, USA, Inc. ("Siemens", NYSE: SI), marked the first dose shipped from a PETNET Solutions manufacturing facility as part of a collaboration with Avid on Florbetapir F 18 (18F-AV-45 or Florbetapir), Avid's molecular imaging agent for positron emission tomography (PET) imaging of β-amyloid deposits in the brain, a key pathological component of Alzheimer's disease.
PETNET Solutions Announces Sodium Fluoride Trial Program to Help Alleviate 99mTc Shortage
March 19, 2010
Knoxville, Tenn., March 19, 2010 - PETNET Solutions, Inc. a wholly-owned subsidiary of Siemens Medical Solutions USA, Inc. announced today that it will use its national network of 47 radiopharmacies to distribute 18F Sodium Fluoride (NaF) free of charge for a limited time period in an effort to alleviate the effects of the global molybdenum shortage.
Siemens to Supply 18F Sodium Fluoride Nationwide through PETNET Solutions
March 5, 2010
Knoxville, Tenn., March 5, 2010 - PETNET Solutions, a wholly-owned subsidiary of Siemens Medical Solutions USA, Inc. announced today that it is prepared to distribute, on a national basis, 18F-sodium fluoride (18F-NaF) through its network of 47 PET radiopharmacies in the U.S.
Knoxville, Tenn., October 30, 2009 - PETNET Solutions, a wholly-owned subsidiary of Siemens Medical Solutions, announced today that it is a registered supplier of 18F-sodium fluoride (18F-NaF) and investigational 3'Deoxy-3'[18F] Fluorothymidine (18F-FLT) to the American College of Radiology Imaging Network (ACRIN) in support of ACRIN's multi-center clinical trials.
Study Offers Hope for Advancement in Cancer Diagnosis and Treatment
September 23, 2009
Montreal, Canada, Sept. 23, 2009 - Siemens Healthcare announced today the initial findings of a new imaging biomarker developed by its molecular imaging biomarker research facility in collaboration with Dr. Jian Q. (Michael) Yu and Fox Chase Cancer Center in Philadelphia. The new imaging agent was designed to capture and quantify the cellular expression of CA-IX, an enzyme whose expression has been linked to tumor growth and invasion, as well as hypoxia. The results were presented today at the World Molecular Imaging Conference in Montreal.
Knoxville, Tenn., July 17, 2009 - PETNET Solutions, a wholly owned subsidiary of Siemens Medical Solutions USA, Inc. announced today that they are a registered supplier of investigational 3'Deoxy-3'[18F] Fluorothymidine (F-18 FLT) to the Society of Nuclear Medicine's Clinical Trial network. This was made possible via a cross reference from Siemens Molecular Imaging/PETNET's Drug Master File (DMF) to the SNM's centralized IND.
PETNET Solutions Signs Supply Agreement with Lantheus Medical Imaging
June 11, 2009
Toronto, Canada, June 11, 2009 - PETNET Solutions, a wholly-owned subsidiary of Siemens Medical Solutions USA, Inc., and a leader in radiopharmaceutical manufacturing and distribution, has announced the execution of a supply agreement with Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic imaging, to provide BMS747158 for PET imaging of cardiac perfusion as part of the Phase II and Phase III trials. PETNET Solutions/Siemens has previously supplied all of the clinical trial doses for the Lantheus Phase I study. BMS747158 is Lantheus' novel fluorine 18-labeled Positron Emission Tomography (PET) tracer for myocardial perfusion imaging in subjects under rest and stress conditions.
PETNET Prepared to Address NaF Production Shortages
June 10, 2009
Knoxville, Tenn., June 5, 2009 - PETNET Solutions, a wholly-owned subsidiary of Siemens Medical Solutions USA, Inc., has reported that it is prepared to increase production and availability of 18F Sodium Fluoride (NaF) to replace Technetium for MDP bone scans. The company has taken appropriate steps to help offset shortages of molybdenum, which can result in limited availability of 99mTc-labeled radiopharmaceuticals.
PETNET Solutions Opens North Carolina SPECT Radiopharmacy
March 20, 2009
Knoxville, Tenn., March 20, 2009 - PETNET Solutions, a wholly-owned subsidiary of Siemens Medical Solutions USA, Inc. and a leader in radiopharmaceutical distribution, has announced the opening of a new SPECT radiopharmacy in Raleigh, N.C. Through an agreement with Covidien Medical Imaging, PETNET now offers a combined portfolio of high energy and low energy radioisotopes to the nuclear medicine community, further expanding its PET and single photon emission computed tomography (SPECT) coverage.
Siemens PETNET Solutions, Covidien Enter Co-Marketing Agreement
November 3, 2008
Hoffmann Estates, Ill., Nov. 3, 2008 - PETNET Solutions, a wholly-owned subsidiary of Siemens Medical Solutions USA, Inc. and a leader in radiopharmaceutical distribution, and Covidien, a leading global provider of healthcare products, jointly announce they have entered into a co-marketing agreement to offer a combined portfolio of high-energy and low-energy radioisotopes to the nuclear medicine community in the United States.
Siemens’ PETNET Solutions Poised to Assist During Moly Shortage
October 3, 2008
Malvern, Pa., October 3, 2008 – The recent shortage of Molybdenum has caused a temporary shortage of 99mTc-labeled radiopharmaceuticals and may continue over the next several weeks. PETNET Solutions, a fully owned subsidiary of Siemens Medical Solutions USA Inc., is prepared to increase production and availability of 18F Sodium Fluoride (NaF) to replace Technetium MDP bone scans.
Siemens Strengthens Position in Biomarker Production and Research
June 16, 2008
NEW ORLEANS, La., June 16, 2008 – To help ensure that more healthcare facilities throughout the United States have access to the positron emission tomography•computed tomography (PET•CT) technology that helps clinicians diagnose and treat disease earlier and more effectively, Siemens Healthcare (www.siemens.com/healthcare) has opened two new radiopharmacies in Las Vegas and Pittsburgh.
HOFFMAN ESTATES, Ill., March 26, 2008 – Siemens Healthcare (www.siemens.com/healthcare) today announced its first molecular imaging biomarker production facility in Chennai, India. The new facility will enable the healthcare providers in and around Chennai to access the positron emission tomography•computed tomography (PET•CT) technology to diagnose patients with life-threatening diseases, such as cancer and cardiac and neurological ailments. With this facility, Siemens makes another investment in strengthening critical healthcare infrastructure in the country to elevate the level of available healthcare services.