Guerbet

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

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Tuesday, October 4, 2022
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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)

Retrieved on: 
Wednesday, September 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.

Guerbet: 2022 half-year results

Retrieved on: 
Wednesday, September 21, 2022
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The 2022 half-year financial statements, approved by the Board of Directors on Wednesday, September 21, 2022, underwent a limited review by the statutory auditors.

Key Points: 
  • The 2022 half-year financial statements, approved by the Board of Directors on Wednesday, September 21, 2022, underwent a limited review by the statutory auditors.
  • This discipline enabled it to limit the impact of rising costs of raw materials and other supplies (iodine in particular).
  • As of June 30, 2022, equity totaled 429million, compared with 405million on Friday, December 31, 2021.
  • This did not prevent a further improvement in the debt ratio, with a net debt/equity ratio of 0.59 as of June 30, 2022, compared with 0.64 a year earlier.

Guerbet: Revenue at June 30, 2022

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Thursday, July 21, 2022
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Growth in the second quarter of 2022 reached 13% at current exchange rates and 7.3% at CER.

Key Points: 
  • Growth in the second quarter of 2022 reached 13% at current exchange rates and 7.3% at CER.
  • Many actions, which aim to preserve the Groups operating profit, were already introduced during the first half of 2022.
  • It expects revenue growth, between 2% and 4% on a like-for-like basis and at constant exchange rates.
  • Guerbet (GBT) is listed on Euronext Paris (segment Bmid caps) and generated 732million in revenue in 2021.

Guerbet receives EMA acceptance of Elucirem™ as the Brand Name for Gadopiclenol

Retrieved on: 
Monday, June 13, 2022
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VILLEPINTE, France, June 13, 2022 /PRNewswire/ -- Guerbet (EuronextParis: GBT) (ISIN: FR0000032526), a global leader in medical imaging, announces today that Elucirem, the proposed Guerbet brand name for Gadopiclenol, has been accepted by the European Medicines Agency (EMA).

Key Points: 
  • VILLEPINTE, France, June 13, 2022 /PRNewswire/ -- Guerbet (EuronextParis: GBT) (ISIN: FR0000032526), a global leader in medical imaging, announces today that Elucirem, the proposed Guerbet brand name for Gadopiclenol, has been accepted by the European Medicines Agency (EMA).
  • "We are very pleased with the acceptance of Eluciremas the brand name for Gadopiclenol.
  • Guerbet announced on the 24thof February 2022 the acceptance of EMA to review the Gadopiclenol Centralized Application for Marketing Authorization.
  • Gadopiclenol is an investigational macrocyclic gadolinium-based contrast agent for MRI developed by Guerbet's Research & Development team.

Guerbet: Q1 2022 revenue

Retrieved on: 
Thursday, April 21, 2022
Imaging, GBT, Medical imaging, US Foods, Research, MRI, CER, Food, EBITDA, European Medicines Agency, Group, Solution, AI, Forward-looking statement, Euronext Paris, AMF, Risk management, Pharmaceutical industry, Guerbet

X-Ray revenue gained 2.8% on strong Xenetix sales volumes.

Key Points: 
  • X-Ray revenue gained 2.8% on strong Xenetix sales volumes.
  • The Group is confirming its ambitions for 2022.
  • It expects further revenue growth, between 2% and 4% on a like-for-like basis and at constant exchange rates.
  • Guerbet (GBT) is listed on Euronext Paris (segment Bmid caps) and generated 732 million in revenue in 2021.

Guerbet: 2021 annual results

Retrieved on: 
Wednesday, March 23, 2022
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The EBITDA margin stood at 14.4% above the target range for operating profitability announced with the 2021 half-year results.

Key Points: 
  • The EBITDA margin stood at 14.4% above the target range for operating profitability announced with the 2021 half-year results.
  • As of December 31, 2021, operating income totaled 38.7 million, compared with 41.9 million in 2020.
  • Net income came to 32.6 million in 2021, compared with 18.2 million in 2020.
  • The net debt / EBITDA ratio stood at 2.07 at the end of 2021, compared to 2.55 in 2020.

Gadopiclenol Marketing Authorization dossier submissions accepted for review by EMA and FDA

Retrieved on: 
Tuesday, March 29, 2022
ClinicalTrials.gov, Marketing, GBCA, Central Applications Office, Diagnosis, Trial of the century, European Medicines Agency, Euronext Paris, Research, Food, Artificial intelligence, Review, Safety, Priority review, Regulation of tobacco by the U.S. Food and Drug Administration, EMA, NDA, Solution, FDA, GBT, AI, Medical device, Pharmaceutical industry, Guerbet

VILLEPINTE, France, March 29, 2022 /PRNewswire/ -- Guerbet (FR0000032526 GBT), a global leader in medical imaging offering a comprehensive range of pharmaceutical products, medical devices, and digital and artificial intelligence (AI) solutions for diagnostic and interventional imaging, has recently submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a Centralized Application for Marketing Authorization to the European Medicine Agency (EMA) for Gadopiclenol, an investigational macrocyclic gadolinium-based contrast agent (GBCA). Those applications have been accepted for review by EMA and FDA on February 24 and March 28, respectively. 

Key Points: 
  • Those applications have been accepted for review by EMA and FDA on February 24 and March 28, respectively.
  • In addition, the US-FDA has accepted the request for Priority Review with a goal date for taking action on an application by September 21, 2022.
  • The dossiers are supported by the data from two Phase III studies for the investigational macrocyclic GBCA, Gadopiclenol completed in March 2021.
  • The efficacy and safety of Gadopiclenol have been evaluated as part of the company's clinical development plan with a view to obtaining worldwide marketing authorization.

Guerbet expands portfolio with microcatheters and guidewires for interventional imaging and embolization

Retrieved on: 
Monday, March 7, 2022
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VILLEPINTE, France, March 7, 2022 /PRNewswire/ -- Guerbet (FR0000032526 GBT), a global leader in medical imaging, announcesit will more than double its line of microcatheters and launch a new line of guidewires, resulting in a broad range of interventional imaging and embolization solutions available.

Key Points: 
  • VILLEPINTE, France, March 7, 2022 /PRNewswire/ -- Guerbet (FR0000032526 GBT), a global leader in medical imaging, announcesit will more than double its line of microcatheters and launch a new line of guidewires, resulting in a broad range of interventional imaging and embolization solutions available.
  • Guerbet now expands the portfolio, adding 20 versions for a total of 38, and launching a new line of Axessio guidewires with two diameters.
  • With strategic acquisitions that helped create a unique toolkit of microcatheters and this latest portfolio extension, we're advancing options for the interventional radiology community."
  • We are a leader in medical imaging worldwide, offering a comprehensive range of pharmaceutical products, medical devices, and digital and AI solutions for diagnostic and interventional imaging.

Guerbet expands portfolio with microcatheters and guidewires for interventional imaging and embolization

Retrieved on: 
Monday, March 7, 2022
Euronext Paris, Patient, Research, VP, IIB, NSAI, GBT, FDA, Solution, DRAKON, Therapy, Sale, Agent handling, Senior, Acquisition, EC, Law of the United States, CE, PCI, Technology, AI, Physician, III, Radiology, Guidewire Software, Medical imaging, Pharmaceutical industry, Medical device, EU, Guerbet

VILLEPINTE, France, March 7, 2022 /PRNewswire/ -- Guerbet (FR0000032526 GBT), a global leader in medical imaging, announcesit will more than double its line of microcatheters and launch a new line of guidewires, resulting in a broad range of interventional imaging and embolization solutions available.

Key Points: 
  • VILLEPINTE, France, March 7, 2022 /PRNewswire/ -- Guerbet (FR0000032526 GBT), a global leader in medical imaging, announcesit will more than double its line of microcatheters and launch a new line of guidewires, resulting in a broad range of interventional imaging and embolization solutions available.
  • Guerbet now expands the portfolio, adding 20 versions for a total of 38, and launching a new line of Axessio guidewires with two diameters.
  • With strategic acquisitions that helped create a unique toolkit of microcatheters and this latest portfolio extension, we're advancing options for the interventional radiology community."
  • We are a leader in medical imaging worldwide, offering a comprehensive range of pharmaceutical products, medical devices, and digital and AI solutions for diagnostic and interventional imaging.