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). The approval granted by the EC followed 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 EC.
MONROE TOWNSHIP, N.J., Oct. 17, 2022 /PRNewswire/ -- Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, announced today that it will feature the recently approved Gadopiclenol Injection, a novel, highly stable macrocyclic gadolinium-based contrast agent (GBCA), commercialized as VUEWAY™ (gadopiclenol) injection by Bracco, among a robust line of imaging products, devices, and support solutions, at the 2022 Radiological Society of North America (RSNA) annual congress, held November 27 through December 1.i,ii Gadopiclenol Injection shows the highest relaxivity and highest kinetic stability of all GBCAs in the marketi at half the approved dose of Gadobutrol injection and Gadobenate dimeglumine injection, another high-relaxivity agent.iii,iv,v Please see Indications and Important Safety Information below, including Boxed Warning.
MONROE TOWNSHIP, N.J., Sept. 21, 2022 /PRNewswire/ -- Bracco Diagnostics Inc., the United States (U.S.) subsidiary of Bracco Imaging S.p.A., an innovative world leader in diagnostic imaging, announced today that the U.S. Food and Drug Administration (FDA) has approved Gadopiclenol Injection, a new, highly stable macrocyclic gadolinium-based contrast agent (GBCA), which shows the highest relaxivity compared to all the other GBCAs available today in the United States.i,ii Gadopiclenol Injection will be commercialized by Bracco as VUEWAY (gadopiclenol) injection and VUEWAY (gadopiclenol) Pharmacy Bulk Package. VUEWAY injection is approved for use with MRI in adults and pediatric patients aged 2 years and older to detect and visualize lesions in the central nervous system (brain, spine and associated tissues) and the body (head and neck, thorax, abdomen, pelvis and musculoskeletal system)ii The approved dose is 0.05 mmol/kg, which was shown to improve the detection and visualization of lesions over unenhanced MRI alone, and to provide similar diagnostic efficacy compared with 0.1 mmol/kg of the lower-relaxivity Gadobutrol injection in the approved indications.iii,iv Please see Indications and Important Safety Information below, including Boxed Warning.
OXFORD, United Kingdom & BURLINGTON, Mass.--(BUSINESS WIRE)--Blue Earth Therapeutics, a Bracco company and emerging leader in the development of innovative next generation therapeutic radiopharmaceuticals, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug Application (IND) application for 177Lu-rhPSMA-10.1. IND authorization to proceed enables Blue Earth Therapeutics to initiate a Phase 1/2 clinical study to evaluate the safety, tolerability, dosimetry and anti-tumor activity of 177Lu-rhPSMA-10.1 in men with metastatic castrate-resistant prostate cancer (mCRPC). 177Lu-rhPSMA-10.1 is the first clinical candidate in Blue Earth Therapeutics’ oncology development program of next generation therapeutic radiopharmaceuticals. Blue Earth Therapeutics holds exclusive worldwide rights to therapeutic applications of radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) radiopharmaceutical technology to help advance the treatment of patients with prostate cancer.
December 14, 2021 (7:00 a.m. CET) – Guerbetn(FR0000032526 GBT), a global leader in medical imaging offering a ncomprehensive range of pharmaceutical products, medical devices, and ndigital and artificial intelligence (AI) solutions for diagnostic and ninterventional imaging, and Bracco Imaging, an innovative world leader ndelivering end-to-end products and solutions through a comprehensive nportfolio inclusive of precision diagnostic imaging modalities, today nannounced they have signed a global collaboration for Gadopiclenol, a nnext-generation magnetic resonance imaging (MRI) contrast agent. This nglobal collaboration will result in Guerbet and Bracco Imaging ncommercializing the product independently under different brand names. nThe companies will also collaborate on manufacturing, as well as nresearch and development for future indications. Financial terms of the ntransaction are not disclosed.
Molecular PET agent developer Blue Earth Diagnostics has been picked up by the Italian multinational Bracco, which will take in the company as a subsidiary under its medical imaging banner.
KINEVAC® (Sincalide): BRACCO DIAGNOSTICS INC., v.MAIA PHARMACEUTICALS, INC., )
Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, today announced that the U.S. Food and Drug Administration (FDA) approved TAGITOL V (barium sulfate) oral suspension for use in adult patients undergoing a CTC.
Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, today announced the U.S. Food and Drug Administration (FDA) approved VARIBAR NECTAR (barium sulfate) oral suspension for use in modified barium swallow (MBS) examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients with known or suspected swallowing disorders.
“We are very pleased that Ferring has received its second approval for Vitaros in Latin America,” said Richard Pascoe, Chief Executive Officer of Apricus. “Moreover, we look forward to Ferring’s launches of Vitaros in Latin America throughout the year, in addition to the portfolio of countries across the EU they have the rights to as well. Again, congratulations to the Ferring team for their continued commitment to building the Vitaros global brand.”