The US Food and Drug Administration(FDA)is set to initiate a five-year project to create a public database of the gene sequences of 100,000 bacteria,as a part of its effort to rapidly identify the source of contamination and bring foodborne ...
Tags: FDA, foodborne outbreaks, five-year project
GlaxoSmithKline (GSK) and Theravance have announced the regulatory submissions for furoate FF/vilanterol VI (FF/VI) to treat chronic obstructive pulmonary disease (COPD) in the US and Europe. The companies also announced regulatory ...
The US Food and Drug Administration (FDA) has granted 510(k) approval to Olea Medical's Olea Sphere medical imaging enterprise software. Olea Sphere provides display, analysis and post-processing functionality for viewing perfusion ...
Tags: medical imaging enterprise software, imaging enterprise software
HTG Molecular Diagnostics has licensed Merck's breast cancer marker to develop, manufacture, and market breast cancer diagnostic tests. HTG Molecular Diagnostics CEO TJ Johnson said the ability to quickly, and locally assess a patient's ...
Athersys has received FDA orphan drug designation for its proprietary cell therapy, MultiStem, to treat Hurler's syndrome, also known as mucopolysaccharidosis type I or MPS-I. The orphan drug designation provides substantial potential ...
The US government's Egg Safety Rule,which features standards to prevent Salmonella contamination at laying facilities,has come into effect from 9 July 2012. Previously,the rule was applicable only for large egg producers with over 50,000 ...
Tags: Egg Safety Rule, Salmonella, small producers
US-based Twin Rivers Paper has launched Acadia Natural,a compostable and recyclable paper made from unbleached pulp,for use in food packaging. According to the company,the packaging can be used for applications such as fast-food sandwich ...
Tags: recyclable paper, food packaging, fast-food
The proposed $4.7 billion sale of Smithfield Foods, America's largest pork producer, to China's biggest meat processing company comes amid significant trade friction between the two countries over meat and livestock. China bans ...
Tags: Drug, Agriculture, Food
Bristol-Myers Squibb (BMY) and Eli Lilly (LLY) have received an approval from US Food and Drug Administration (FDA) to expand the use of Erbitux in combination with the chemotherapy regimen Folfiri as an initial treatment of patients with ...
Tags: FDA approval, Erbitux, KRAS mutation-negative colorectal cancer
Eli Lilly and Company has met the United States Food and Drug Administration (FDA) requirements for pediatric exclusivity for Cymbalta (duloxetine HCl), which is available in 20-mg, 30-mg, and 60-mg capsules. As part of the approval, ...
The US Food and Drug Administration (FDA) has granted premarket approval (PMA) to Roche's new fully automated COBAS AmpliPrep / COBAS TaqMan CMV test to quantify cytomegalovirus' (CMV) DNA in human plasma specimens. The real-time ...
Tags: Roche, FDA, Viral Load Test, PCR-based CMV test
Stimatix GI, a developer of stomal management solutions, has received CE mark approval for its AOS-C2000 colostomy device. The AOS-C2000 is designed to provide voluntary bowel evacuation and improve the quality of life of people suffering ...
Tags: AOS-C2000 colostomy device, colostomy device, AOS-C1000 colostomy device
US distribution deal for spectral blood sensor 03 Jul 2012 PSS World Medical to market Masimo's latest multi-wavelength spot-checker for hemoglobin,pulse rate and perfusion index. Pronto-7 oximeter Masimo Corporation,the US ...
Tags: spectral blood sensor, medical sensor, PSS World Medical
Cornerstone Therapeutics has acquired a privately-held specialty pharmaceutical company focused on the acute-care hospital setting, EKR Therapeutics. As part of the merger, Cornerstone will assume the responsibility to market and promote ...
Tags: Cornerstone Therapeutics
The US FDA has granted priority review designation to Bayer HealthCare's new drug application (NDA) filed for regorafenib to treat patients with metastatic colorectal cancer (mCRC) whose disease has progressed after approved standard ...
Tags: US FDA, Bayer HealthCare, NDA