Piramal Imaging SA

Type: Company
Name: Piramal Imaging SA
First reported Apr 07 2014 - Updated Apr 07 2014 - 1 reports

US FDA approves Piramal Imaging's Neuraceq

Will help in PET imaging of beta-amyloid neuritic plaques in the brainUS Food and Drug Administration (US FDA) has approved Piramal Imaging's Neuraceq. This approval comes only four weeks after receiving marketing authorisation for Neuraceq from the European ... [Published Express Pharma - Apr 07 2014]
First reported Apr 02 2014 - Updated Apr 02 2014 - 1 reports

NEURACEQ (Florbetaben F 18) Injection, Solution [Piramal Imaging, SA]

Entities: Piramal Imaging SA
First reported Mar 31 2014 - Updated Mar 31 2014 - 1 reports

3/31/14 - FDA Approves Piramal Imaging's Neuraceqâ?¢ florbetaben F18 injection for PET Imaging of Beta-Amyloid Neuritic Plaques in the Brain

By a News Reporter-Staff News Editor at Mental Health Weekly Digest Piramal Imaging announced that the U.S. Food and Drug Administration (FDA) has approved Neuraceq?. This approval comes only four weeks after receiving marketing authorization for Neuraceq? ... [Published Pharmacy Choice - Mar 31 2014]
First reported Mar 26 2014 - Updated Mar 26 2014 - 1 reports

Piramal Imaging receives FDA approval for PET imaging agent

Piramal Imaging, a division of Piramal Enterprises, Ltd., has received the FDA approval for Neuraceq for positron emission tomography, or PET, imaging of beta-amyloid neuritic plaques in the brain. This approval comes only four weeks after receiving marketing ... [Published Individual.com - Mar 26 2014]
First reported Mar 25 2014 - Updated Mar 25 2014 - 2 reports

FDA approves third Alzheimer's PET agent

Piramal Imaging announced that the U.S. Food and Drug Administration has approved its PET amyloid imaging agent.The imaging agent, called Neuraceq, is used in the visual detection of beta amyloid in the brains of patients being evaluated for Alzheimer's ... [Published Dotmed - Mar 25 2014]
First reported Mar 25 2014 - Updated Mar 25 2014 - 1 reports

UA College of Medicine-Phoenix neurologist's studies at center of FDA approval of biomarkers for Alzheimer’s testing

A Boston-based company has received federal approval for a compound that can be administered to gauge levels of beta-amyloid plaque in the brain, which can indicate the likelihood of a patient having Alzheimer’s disease.The product, named Neuraceq and ... [Published Business First of Buffalo - Mar 25 2014]
First reported Mar 24 2014 - Updated Mar 24 2014 - 1 reports

Why the FDA’s recent approval of brain biomarkers may help Alzheimer’s efforts

A Boston-based company has received approval for a compound that can be administered to better gauge levels of beta-amyloid plaque in the brain, which can in turn indicate the likelihood of a patient having Alzheimer’s disease.The product, named Neuraceq ... [Published Business First of Buffalo - Mar 24 2014]
First reported Mar 21 2014 - Updated Mar 22 2014 - 2 reports

3/21/2014 Third Amyloid Imaging Agent Approved by the FDA

Earlier this week, the US Food and Drug Administration (FDA) approved the radioactive diagnostic agent florbetaben F18 injection (Neuraceq). Florbetaben is used with positron emission tomography imaging of the brain to estimate amyloid beta (Abeta) plaques ... [Published Neurology Today - Mar 22 2014]
First reported Mar 21 2014 - Updated Mar 21 2014 - 1 reports

Piramal Imaging Gets FDA Approval for Neuraceq

The FDA has approved Piramal Imaging’s molecular imaging agent Neuraceq, just four weeks after it received approval from the European Commission, the Swiss company said Thursday.The injectable drug is indicated for positron emission tomography (PET) imaging ... [Published FDA News - Mar 21 2014]
First reported Mar 20 2014 - Updated Mar 21 2014 - 5 reports

FDA OKs Piramal's Neuraceq PET agent

-- Piramal Imaging has received U.S. Food and Drug Administration approval for its Neuraceq PET imaging agent.To get access to this article and all of the content on AuntMinnie.com, create a free account or sign-in now.Member Sign In:* MemberID or E-mail ... [Published Aunt Minnie - Mar 21 2014]
First reported Mar 20 2014 - Updated Mar 20 2014 - 2 reports

FDA Approves Piramal Imaging's Neuraceq™ (florbetaben F18 injection) for PET Imaging of Beta-Amyloid Neuritic Plaques in the Brain

BERLIN and BOSTON, March 20, 2014 /PRNewswire/ -- Piramal Imaging today announced that the U.S. Food and Drug Administration (FDA) has approved Neuraceq™. This approval comes only four weeks after receiving marketing authorization for Neuraceq™ from ... [Published PR Newswire: Policy & Public Interest - Mar 20 2014]
First reported Dec 20 2013 - Updated Dec 20 2013 - 1 reports

CHMP recommends Piramal Imagingâs NeuraCeq for EU Approval

CHMP recommends Piramal Imaging’s NeuraCeq for EU ApprovalOur Bureau, MumbaiThe European Union’s Committee for Medicinal Products for Human Use (CHMP) today recommended the approval of Piramal Imagings' NeuraCeq (florbetaben 18F). The CHMP's recommendation ... [Published PharmaBiz - Dec 20 2013]

Quotes

...Swati Piramal, Vice Chairperson, Piramal Enterprises Ltd. "The rising prevalence of Alzheimer's disease and cognitive impairment is being felt individually and collectively around the world. Our goal as a company is to usher in a new era of imaging that helps paint clearer pictures of the physiology of such conditions and helps improve patient outcomes."
"Correlation of the visual PET interpretation with histopathology in these 82 brains demonstrated that Neuraceq accurately detects moderate to frequent beta-amyloid neuritic plaques in the brain and is a useful tool to estimate the density of these plaques in life" said a statement from Piramal
...post mortem histopathology in the 82 brains showed the agent accurately detected moderate to frequent plaques in the brain, the statement adds, "and is a useful tool to estimate the density of these plaques in life."
...opinion, recommending the granting of a marketing authorisation for the medicinal product Neuraceq with the following therapeutic indication. "This medicinal product is for diagnostic use only. Neuraceq is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of ß-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive impairment. Neuraceq should be used in conjunction with a clinical evaluation."

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All (21) | News (19) | Reports (0) | Blogs (2) | Audio/Video (0) | Fact Sheets (0) | Press Releases (0)
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US FDA approves Piramal Imaging's Neuraceq [Published Express Pharma - Apr 07 2014]
NEURACEQ (Florbetaben F 18) Injection, Solution... [Published DailyMed Drug Label Updates for the last seven ... - Apr 02 2014]
3/31/14 - FDA Approves Piramal Imaging's Neurac... [Published Pharmacy Choice - Mar 31 2014]
Piramal Imaging receives FDA approval for PET i... [Published Individual.com - Mar 26 2014]
FDA approves third Alzheimer's PET agent [Published Dotmed - Mar 25 2014]
UA College of Medicine-Phoenix neurologist's st... [Published Business First of Buffalo - Mar 25 2014]
FDA Provides Approval for Piramal Imaging's Neu... [Published Individual.com - Mar 25 2014]
Why the FDA’s recent approval of brain biomarke... [Published Business First of Buffalo - Mar 24 2014]
3/21/2014 Third Amyloid Imaging Agent Approved ... [Published Neurology Today - Mar 22 2014]
Piramal Imaging Gets FDA Approval for Neuraceq [Published FDA News - Mar 21 2014]
FDA Approves Third Amyloid PET Tracer for Alzhe... [Published General Medicine eJournal - Mar 21 2014]
FDA OKs Piramal's Neuraceq PET agent [Published Aunt Minnie - Mar 21 2014]
Piramal Imaging gets USFDA approval for Neuraceq [Published MyIris - Mar 21 2014]
FDA approves Piramal Imaging’s Neuraceq [Published India Infoline - Mar 21 2014]
Imaging Agent Approved As Part of Evaluation fo... [Published ASHP - Mar 20 2014]
FDA approves Neuraceq amyloid PET agent [Published HealthImaging - Mar 20 2014]
FDA Approves Piramal Imaging's Neuraceq™ (florb... [Published PR Newswire: Policy & Public Interest - Mar 20 2014]
FDA Approves Piramal Imaging’s NeuraceqTM (flor... [Published Noodls - Mar 20 2014]
CHMP adopts positive opinion for Neuraceq [Published Pharmaceutical Business Review - Dec 24 2013]
CHMP recommends Piramal Imagingâs NeuraCeq for ... [Published PharmaBiz - Dec 20 2013]
Piramal partners with Ci-Co Healthcare for comm... [Published PharmaBiz - Nov 21 2013]
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NEURACEQ (Florbetaben F 18) Injection, Solution... [Published DailyMed Drug Label Updates for the last seven ... - Apr 02 2014]
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FDA Approves Piramal Imaging's Neuraceq™ (florb... [Published PR Newswire: Policy & Public Interest - Mar 20 2014]
BERLIN and BOSTON, March 20, 2014 /PRNewswire/ -- Piramal Imaging today announced that the U.S. Food and Drug Administration (FDA) has approved Neuraceq™. This approval comes only four weeks after receiving marketing authorization for Neuraceq™ from ...
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