Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 31 n° 344

Posts Tagged ‘Magnetic resonance imaging’

American Chemical Society applauds Senate, urges swift passage of helium bill

Posted by fidest press agency su domenica, 22 settembre 2013

WASHINGTON The American Chemical Society (ACS) applauds the Senate action today in passing helium supply legislation by a vote of 97 to 2.
“ACS urges the House and Senate to swiftly conference this legislation so it can be presented to President Barack Obama for his immediate signature,” said ACS President Marinda Li Wu, Ph.D.“MRIs that image cancer tumors use helium,” said Wu. “Heart patients rely on helium for proper catheterization during surgery. It’s vital for national defense. Even scuba divers who conduct rescue operations rely on helium. If the liquid helium supply was to suddenly vanish, our society would be turned upside down.”The Senate’s urgent vote was held to stave off closure of the Amarillo, Texas, helium production facilities, which have been operated by the U.S. Bureau of Land Management (BLM) under the Federal Helium Program — set to expire on Oct. 7, 2013. Availability of helium reached a critical point when BLM announced it would begin shutting the Amarillo facility down as early as mid-September, as the world’s second-largest supply in Wyoming shut down earlier in September for maintenance.Legislation is needed to permit the BLM to continue operating the Amarillo helium facility until 2015, when the commodity can be privatized. ACS has supported both the House and Senate bills, respectively: H.R. 527 and S. 783 — taking the position that making sure that helium supplies are available and uninterrupted is the primary concern.The American Chemical Society is a nonprofit organization chartered by the U.S. Congress. With more than 163,000 members, ACS is the world’s largest scientific society and a global leader in providing access to chemistry-related research through its multiple databases, peer-reviewed journals and scientific conferences. Its main offices are in Washington, D.C., and Columbus, Ohio.

Posted in Economia/Economy/finance/business/technology, Estero/world news | Contrassegnato da tag: , , , | Leave a Comment »

FDA Approves Dotarem® (gadoterate meglumine), First Macrocyclic and Ionic Gadolinium-based Contrast Agent in USA

Posted by fidest press agency su giovedì, 28 marzo 2013

Villepinte, France, PRNewswire Guerbet announced today that the US Food and Drug Administration (FDA) has approved Dotarem® (gadoterate meglumine), a gadolinium-based contrast agent (GBCA) indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (2 years of age and older) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity. Dotarem® — which has been commercialized widely throughout the world since 1989 and more than 37 million doses administered[1] — is the only macrocyclic and ionic GBCA. The recommended dose is 0.2 mL/kg (0.1 mmol/kg) body weight (BW). Dotarem® Injection 0.5 mmol/mL contains 376.9 mg/mL of gadoterate meglumine, and is available in vials and pre-filled syringes.MRI has become the mainstay of central nervous system imaging since its introduction over 20 years ago. It is estimated that there were more than 10 million contrast-enhanced MRI examinations performed in the US in 2011, with approximately 60% of these examinations performed to image the CNS.
In compliance with recommendations issued by national, European (EMA) and US (FDA) drug safety agencies, product leaflets and prescribing information for gadolinium-based contrast products contain information on the risks of nephrogenic systemic fibrosis (FSN).
For further information on Dotarem®, and notably full safety information, refer to the summary of the product characteristics in force in your country. The Dotarem® New Drug Application included two Phase III clinical studies. These studies evaluated the diagnostic efficacy and safety of Dotarem® for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (2 years of age and older) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity. Both phase III studies evaluated the superiority of the enhanced images over the unenhanced images for central nervous system (CNS) lesion visualization in all three co-primary endpoints. All defined primary and key secondary efficacy analyses were met and support the efficacy of Dotarem® at a standard dose of 0.1 mmol/kg BW. In addition to these two studies, 21 supportive clinical studies evaluated the efficacy and safety of Dotarem®-enhanced MRI. Commercialized widely in over 70 countries in Europe, Asia, Africa, Middle East and South America, more than 37 million doses of Dotarem® have been administered. The approved indications for Dotarem® may vary between countries. Dotarem® is the leading contrast agent in Europe with 47% market share in 2012[2]. A pioneer in the field of contrast agents with more than 80 years of experience, Guerbet is the only pharmaceutical group fully dedicated to medical imaging worldwide. As such it has a complete offering of contrast products for Xray and MRI and for interventional radiology, along with a range of injectors and related medical equipment to provide improved diagnosis and treatment of patients.
This press release may contain forward-looking statements based on current assumptions and forecasts made by Guerbet Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performances of the company and the estimates given here. These factors include those discussed in Guerbet’s public reports which are available on the Guerbet website at http://www.guerbet.com. The company assumes no liability whatsoever to update these forward-looking-statements or to conform them to future events or developments.

Posted in Economia/Economy/finance/business/technology, Estero/world news | Contrassegnato da tag: , , , | 3 Comments »