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PETNET Solutions Press Releases

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.

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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.

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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.

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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.

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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.

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PETNET Solutions Receives FDA Approval for Fludeoxyglucose F 18 Injection, USP
Demonstrates industry leadership well in advance of regulatory requirements

March 9, 2011

Knoxville, Tenn., March 9, 2011 - PETNET Solutions, Inc. a wholly-owned subsidiary of Siemens Medical Solutions USA, Inc. announced today the approval of an Abbreviated New Drug Application (ANDA) for Fludeoxyglucose F 18 Injection, USP ([18F]FDG). PETNET Solutions' submission of an ANDA, well in advance of regulatory requirements for the positron emission tomography (PET) radiopharmaceutical industry, reinforces its industry leadership in manufacturing and distribution of [18F]FDG. Siemens PETNET Solutions is the first commercial manufacturer and distributor to achieve approval of an ANDA for [18F]FDG.

Full Article    Full Article    Fludeoxyglucose F 18 Injection, Full Prescribing Information

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.

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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.

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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.

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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.

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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.

Full Article    Biomarker Insert

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.

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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.

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