GBCA

The European Commission granted Marketing Authorisation for Vueway® (gadopiclenol) in the European Union

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星期一, 十二月 11, 2023
CNS, Lung, Health, Neck, Prostate, Medical University of Vienna, Breast, Brain, Safety, Food, European Medicines Agency, Paediatric-use marketing authorisation, European Commission, Head, University, Medical imaging, Human, Liver, Spine, GBCA, Google Images, PICTURE, Gadolinium, EMA, Civil service commission, Patient, Marketing authorisation, European, Gadobutrol, Neurology, FDA, Kidney, Pancreas, European Committee for Standardization, CHMP, BBB, Monroe Dunaway Anderson, Committee, Pathology, Gastroenterology, MRI, Central nervous system, MD Anderson Cancer Center, Medical school, Environment, Vaccine, Rare-earth element

Following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), and the recommendation sent by EMA to the European Committee (EC), the EC has granted Marketing Authorisation for Vueway® (gadopiclenol) in the European Union.

Key Points: 
  • Following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), and the recommendation sent by EMA to the European Committee (EC), the EC has granted Marketing Authorisation for Vueway® (gadopiclenol) in the European Union.
  • MILAN, Dec. 11, 2023 /PRNewswire/ -- Bracco Imaging S.p.A., an innovative world leader delivering end-to-end products and solutions through a comprehensive portfolio inclusive of precision diagnostic imaging modalities, announces that on December 7, 2023 the European Commission (EC) has granted the Marketing Authorisation for Vueway® (gadopiclenol) in the European Union (EU).
  • 1,2
    "The final approval of gadopiclenol by the European Commission marks a significant milestone in the field of diagnostic imaging.
  • This innovation benefits healthcare providers but also, more importantly, patients who undergo MRI scans and those living with chronic conditions.

The European Commission granted Marketing Authorisation for Vueway® (gadopiclenol) in the European Union

Retrieved on: 
星期一, 十二月 11, 2023
CNS, Lung, Health, Neck, Prostate, Medical University of Vienna, Breast, Brain, Safety, Food, European Medicines Agency, Paediatric-use marketing authorisation, European Commission, Head, University, Medical imaging, Human, Liver, Spine, GBCA, Google Images, PICTURE, Gadolinium, EMA, Civil service commission, Patient, Marketing authorisation, European, Gadobutrol, Neurology, FDA, Kidney, Pancreas, European Committee for Standardization, CHMP, BBB, Monroe Dunaway Anderson, Committee, Pathology, Gastroenterology, MRI, Central nervous system, MD Anderson Cancer Center, Medical school, Environment, Vaccine, Rare-earth element

Following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), and the recommendation sent by EMA to the European Committee (EC), the EC has granted Marketing Authorisation for Vueway® (gadopiclenol) in the European Union.

Key Points: 
  • Following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), and the recommendation sent by EMA to the European Committee (EC), the EC has granted Marketing Authorisation for Vueway® (gadopiclenol) in the European Union.
  • MILAN, Dec. 11, 2023 /PRNewswire/ -- Bracco Imaging S.p.A., an innovative world leader delivering end-to-end products and solutions through a comprehensive portfolio inclusive of precision diagnostic imaging modalities, announces that on December 7, 2023 the European Commission (EC) has granted the Marketing Authorisation for Vueway® (gadopiclenol) in the European Union (EU).
  • 1,2
    "The final approval of gadopiclenol by the European Commission marks a significant milestone in the field of diagnostic imaging.
  • This innovation benefits healthcare providers but also, more importantly, patients who undergo MRI scans and those living with chronic conditions.

Guerbet announces marketing authorisation approval of Elucirem™ (Gadopiclenol) in the European Union

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星期一, 十二月 11, 2023
Syringe, Safety, Regulatory affairs, European Medicines Agency, Aulnay-sous-Bois, European Commission, Ageing, GBCA, Gadolinium, Civil service commission, Medicine, European, FDA, CHMP, BBB, Marketing, Committee, Pathology, Marans, Charente-Maritime, Person, Medical imaging, Seine-Saint-Denis, MRI, Radiology

The marketing authorisation (MA) for Elucirem™ (Gadopiclenol) was granted to Guerbet by the European Commission based on the positive opinion of the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) dated 12 October 2023.

Key Points: 
  • The marketing authorisation (MA) for Elucirem™ (Gadopiclenol) was granted to Guerbet by the European Commission based on the positive opinion of the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) dated 12 October 2023.
  • It will be marketed by Guerbet in the European Union in the following forms: vials and prefilled syringes.
  • "After its approval by the FDA for the American market, the European marketing authorisation for Elucirem™ reinforces our strategic perspective: combining medical innovation and environmental commitment.
  • This authorisation is ground-breaking for Medical Imaging in Europe," concludes David Hale, Guerbet CEO.

Bayer initiates Phase III studies with investigational contrast agent gadoquatrane

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星期二, 六月 27, 2023
Health, Other Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Tissue, Central nervous system, Radiology, Cancer, Diagnosis, GBCA, MRI, Interventional radiology, Magnetic resonance imaging, Patient, Physician, Conditional sentence, Phase, Safety, Medical imaging, Bayer

Bayer, a global leader in radiology, has initiated the Phase III clinical development program called QUANTI, aiming to evaluate the safety and efficacy of gadoquatrane, an investigational extracellular macrocyclic gadolinium-based contrast agent (GBCA) for use in magnetic resonance imaging (MRI).

Key Points: 
  • Bayer, a global leader in radiology, has initiated the Phase III clinical development program called QUANTI, aiming to evaluate the safety and efficacy of gadoquatrane, an investigational extracellular macrocyclic gadolinium-based contrast agent (GBCA) for use in magnetic resonance imaging (MRI).
  • Gadoquatrane is a highly stable MRI contrast agent featuring high relaxivity being studied to evaluate the potential of a substantially lower gadolinium (Gd) dose for patients.1
    The QUANTI clinical development program encompasses two large multinational Phase III studies, QUANTI CNS (central nervous system) and QUANTI OBR (other body regions), as well as one pediatric study, all investigating gadoquatrane at a dose of 0.04mmol Gd/kg body weight (bw).
  • The completion of a successful development program would demonstrate the lowest gadolinium dose for an MRI contrast agent.
  • “In addition to this potentially novel contrast agent gadoquatrane, Bayer has new automated injection systems and AI-enabled solutions.”

HONEYWELL SUPPORTS SYDNEY OPERA HOUSE TO REACH SIX STAR GREEN STAR RATING

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星期四, 五月 18, 2023
UNESCO, DNA, U.S. Green Building Council, LEED, Opera house, USGBC, Electricity, IAQ, World Leadership Awards, AC, Temperature, Carbon, Sydney Opera House, GBCA, Ventilation, HVAC, Opera, Data analysis, World Heritage Site, Smoke, Engineering, Air conditioning, EBI, Green building council, Biophysical environment, Heat, BMS, Ecosystem, Environment, House, Safety, Entertainment, Honeywell

SYDNEY, May 18, 2023 /PRNewswire/ -- Honeywell (Nasdaq: HON), a Sydney Opera House Global Goals partner since 2021, today announced its contributions to help the UNESCO World Heritage-listed building achieve a 6 Star Green Star rating from the Green Building Council of Australia (GBCA). Key to this achievement was retrofitting the Sydney Opera House with Honeywell's innovative, ready now technology to help support more sustainable operations and to reduce the building's environmental impact.

Key Points: 
  • SYDNEY, May 18, 2023 /PRNewswire/ -- Honeywell (Nasdaq: HON), a Sydney Opera House Global Goals partner since 2021, today announced its contributions to help the UNESCO World Heritage-listed building achieve a 6 Star Green Star rating from the Green Building Council of Australia (GBCA).
  • The Sydney Opera House is one of the first UNESCO World Heritage-listed buildings to receive a 6 Star Green Star rating, which represents 'World Leadership' in environmental and social sustainability operations.
  • As a globally recognized performing arts venue and World Heritage-listed icon, the Sydney Opera House operates 24/7 requiring close collaboration between Honeywell and the Sydney Opera House's safety, projects, and service teams.
  • The GBCA Green Star Building rating tool is similar to the Leadership in Energy and Environmental Design (LEED) certification system from the U.S. Green Buildings Council (USGBC).

GE HealthCare Expands Contrast Media Portfolio with Launch of MRI Agent Pixxoscan (gadobutrol)

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星期四, 四月 27, 2023
Surgery, Medical Devices, Hospitals, Cardiology, Biotechnology, Health, Pharmaceutical, General Health, Oncology, Exercise, Gadolinium, GE HealthCare, Delayed gadolinium-enhanced magnetic resonance imaging of cartilage, Good manufacturing practice, DCP, Agent handling, Magnetic resonance angiography, GE, Multimedia, GBCA, MRI, Excipient, CGMP, Patient, Liver, Diagnosis, Coronary artery disease, Malignancy, Magnetic resonance imaging, News, Glass, Medical imaging, Gadoteric acid, Rapiscan

GE HealthCare has today announced the launch of Pixxoscan (gadobutrol), its macrocyclic, non-ionic Magnetic Resonance Imaging (MRI) gadolinium-based contrast agent (GBCA).

Key Points: 
  • GE HealthCare has today announced the launch of Pixxoscan (gadobutrol), its macrocyclic, non-ionic Magnetic Resonance Imaging (MRI) gadolinium-based contrast agent (GBCA).
  • Pixxoscan facilitates visualization of abnormal structures or lesions and helps in the differentiation between healthy and pathological tissue.
  • Pixxoscan adds to GE HealthCare’s MRI contrast media portfolio which includes macrocyclic Clariscan (gadoteric acid) as well as Rapiscan, used in stress cardiac MR to aid diagnosis of coronary artery disease and offering an alternative for patients who cannot exercise.
  • For more than 40 years, GE HealthCare imaging agents have been routinely used across MRI, X-ray/CT and ultrasound to enhance clinical images and support diagnosis.

Guerbet Announces Commercial Launch and First Patient Dosing of Elucirem™ (Gadopiclenol) Injection, a Novel New Macrocyclic GBCA for Use in Contrast-Enhanced Magnetic Resonance Imaging (MRI)

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星期一, 二月 13, 2023
Radiology, Brain, NDA, Spine, Diagnosis, Tissue, Safety, Gadolinium, Head, MRI, Abdomen, Pelvis, Hospital, University, Neck, GBCA, Thorax, Relaxation, Proton, Hospital of the University of Pennsylvania, FDA, Magnetic resonance imaging, Neuroradiology, Central nervous system, Perelman School of Medicine at the University of Pennsylvania, Medical imaging, Guerbet

PRINCETON, N.J., Feb. 13, 2023 /PRNewswire/ -- Guerbet, a global leader in medical imaging with more than 30 years of experience in MRI, announced today the commercial launch and dosing of the first patient with Elucirem™ (gadopiclenol) injection following FDA approval in 2022. This next generation GBCA from Guerbet, highly stable macrocyclic gadolinium-based contrast agent (GBCA), has the highest relaxivity in its class for magnetic resonance imaging (MRI) and is indicated for use in adults and children aged 2 years and older.1,4 Elucirem™ requires only half the gadolinium dose of conventional non-specific GBCAs, addressing practitioners' concerns about gadolinium exposure.2,3 The first dosing took place at the Hospital of the University of Pennsylvania in Philadelphia, PA.

Key Points: 
  • Elucirem™ requires only half the gadolinium dose of conventional non-specific GBCAs, addressing practitioners' concerns about gadolinium exposure.
  • 2,3
    PRINCETON, N.J., Feb. 13, 2023 /PRNewswire/ -- Guerbet, a global leader in medical imaging with more than 30 years of experience in MRI, announced today the commercial launch and dosing of the first patient with Elucirem™ (gadopiclenol) injection following FDA approval in 2022.
  • This milestone is the first of many for this novel new product, which has proven to be a promising step forward for the scientific and digital imaging community," said David Hale, Chief Executive Officer at Guerbet.
  • Elucirem is manufactured by Liebel-Flarsheim™ Company LLC, a Guerbet Group company, in Raleigh, North Carolina.

Guerbet Releases First Production Batch of Elucirem™ (Gadopiclenol) Injection, a Novel New Macrocyclic GBCA for Use in Contrast-Enhanced Magnetic Resonance Imaging (MRI)

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星期四, 二月 2, 2023
Acute kidney injury, Brain, Physician, NSF, Spine, Commercial, Tissue, MRI, Head, Abdomen, Food, Pelvis, Patient, Neck, GBCA, Diabetes, Thorax, Risk, Relaxation, Proton, Hypertension, Glomerular filtration rate, FDA, Magnetic resonance imaging, GFR, Central nervous system, Medical imaging, Pharmaceutical industry, Guerbet

PRINCETON, N.J., Feb. 2, 2023 /PRNewswire/ -- Guerbet, a global leader in medical imaging with more than 30 years of experience in MRI, announced today the first production batch has been manufactured and released for Elucirem™ (gadopiclenol) injection following FDA approval on September 21, 2022, after priority review.4  This next generation GBCA from Guerbet, highly stable macrocyclic gadolinium-based contrast agent (GBCA), has the highest relaxivity in its class for magnetic resonance imaging (MRI) and is indicated for use in adults and children aged 2 years and older.1,5

Key Points: 
  • "Releasing the first batch from our production facility in North Carolina is an important moment for everyone at Guerbet and we are proud to see the hard work and dedication come to fruition."
  • Elucirem is manufactured by Liebel-Flarsheim™ Company LLC, a Guerbet Group company, in Raleigh, North Carolina and is now available for order.
  • Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities.
  • The risk for NSF appears highest among patients with:
    Screen patients for acute kidney injury and other conditions that may reduce renal function.

Fresenius Kabi Expands Contrast Agent Portfolio with Launch of Gadoterate Meglumine Injection, USP

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星期二, 十月 4, 2022
Science, Research, Pharmaceutical, Medical Supplies, Health, FDA, Medical Devices, Health Technology, NSF, Fresenius (company), Hospital, Doctor of Philosophy, Meglumine, Adult, Gadolinium, Gadoteric acid, Radiology, Pregnancy, LinkedIn, Hypersensitivity, National Center for Spinal Disorders, Magnetic resonance imaging, CEO, CT, National Center for Health Research, Multimedia, FDA, BBB, Brain, Glomerular filtration rate, Safety, Death, MRI, Headache, Agent handling, GFR, LLC, Health risk assessment, GBCA, Acute kidney injury, Patient, Rash, Diagnosis, Risk, Hypertension, USP, Nephrogenic systemic fibrosis, Spine, Nausea, Diabetes, Medical imaging, Rare-earth element, Medical device, Pharmaceutical industry, Birth control, Guerbet

Fresenius Kabi announced today it has launched Gadoterate Meglumine Injection, USP, a bioequivalent and therapeutic equivalent substitute for the contrast agent Dotarem.

Key Points: 
  • Fresenius Kabi announced today it has launched Gadoterate Meglumine Injection, USP, a bioequivalent and therapeutic equivalent substitute for the contrast agent Dotarem.
  • View the full release here: https://www.businesswire.com/news/home/20221004005162/en/
    Fresenius Kabi Gadoterate Meglumine Injection, USP is an FDA-approved generic for MRI procedures that is fully substitutable for Dotarem.
  • Fresenius Kabi is pleased to expand our contrast agent portfolio and our support for the radiology community with the launch of Gadoterate Meglumine Injection, USP, said John Ducker, president and CEO of Fresenius Kabi USA.
  • Contrast agents are vital to patient diagnosis, and the addition of Fresenius Kabi Gadoterate Meglumine will provide hospitals and clinics across the U.S. with more high-quality choices to support patient care.

Guerbet announces U.S. Food and Drug Administration (FDA) approval of Elucirem™ (Gadopiclenol)

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星期三, 九月 21, 2022
Central nervous system, Safety, Brain, FDA, Food, Central nervous system tumor, European Medicines Agency, MRI, NDA, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, GBT, Abdomen, III, Thorax, GBCA, Spine, Solution, Head, Diagnosis, Pelvis, Research, Human, AI, Neck, Euronext Paris, Gadolinium, USPI, Medical device, Medical imaging, Pharmaceutical industry, Guerbet

VILLEPINTE, France, Sept. 21, 2022 /PRNewswire/ -- Guerbet (FR0000032526 GBT), a global leader in medical imaging, announced today that the U.S. Food and Drug Administration (FDA) after priority review, approved Elucirem™ (Gadopiclenol), a new macrocyclic GBCA for use in contrast-enhanced magnetic resonance imaging (MRI).

Key Points: 
  • VILLEPINTE, France, Sept. 21, 2022 /PRNewswire/ -- Guerbet (FR0000032526 GBT), a global leader in medical imaging, announced today that the U.S. Food and Drug Administration (FDA) after priority review, approved Elucirem (Gadopiclenol), a new macrocyclic GBCA for use in contrast-enhanced magnetic resonance imaging (MRI).
  • "As a pioneer in MR imaging, thanks to the success of our first gadolinium-based macrocyclic contrast agent, we are delighted with the FDA approval of Elucirem.
  • This approval allows patients and practitioners to benefit from the innovations brought by Elucirem."
  • These factors include those mentioned in the public reports of Guerbet, available on its website www.guerbet.com.