Clinical stage biopharmaceutical company Apogenix's Apocept (APG101) has won FDA orphan drug designation to treat myelodysplastic syndromes (MDS). Apogenix also announced the commencement of Apocept Phase I trial in MDS patients in ...
Tags: FDA, orphan drug, biopharmaceutical
Almac has cleared the FDA inspection and begun US commercial packaging operations in Audubon, Pennsylvania. The FDA concluded that the site is compliant with good manufacturing practices, with no 483 issued. Almac quality vice president ...
Chr. Hansen has appointed Cees de Jong as CEO, replacing Lard Frederiksen who is stepping down after eight years as chief executive and 33 years with the company. De Jong, a doctor of medicine, has worked at various ingredient and ...
US-based biopharmaceutical company Hyperion Therapeutics has announced that it has gained approval from US Food and Drug Administration (FDA) for its RAVICTI (glycerol phenylbutyrate) liquid drug. RAVICTI used for treating Urea Cycle ...
Tags: FDA, drug, biopharmaceutical company
The new CF2000 Series for high-resolution separation and fractionation of nanoparticles, from Postnova Analytics, has won the prestigious GIT Innovations Award 2012 in the category ‘Analytical Instrumentation and Software’. The ...
Tags: Centrifugal Field Flow Fractionation System, Analytical Instrumentation
The Government announced last month that The Centre for Process innovation (CPI) will establish and manage a new £38 million centre to encourage innovative solutions in the UK healthcare market. The National Biologics Industrial ...
Tags: CPI, healthcare market, UK, NBIIC
The US Patent and Trademark Office (USPTO) has granted a notice of allowance (NOA) to biopharmaceutical company Amarin for its claims related to Vascepa and FDA-approved MARINE indication. The NOA, which is issued based on patent ...
Tags: NOA, Vascepa capsules, biopharmaceutical
Shire, a specialty biopharmaceutical company, is set to purchase US-based biotechnology company Lotus Tissue Repair. Under the purchase, Lotus Tissue Repair's intravenous protein replacement therapy, which is in late pre-clinical ...
Tags: Shire, biopharmaceutical company, US, Lotus Tissue Repair
EMD Millipore, the life science division of Merck KGaA has introduced the Mobius FlexRead solution, which boasts Smart Flexware Asemblies for tangential flow filtration. The system gives specialists the ability to switch from TFF to ...
Tags: EMD Millipore, Merck KGaA, life science, tangential flow filtration
Materials characterisation company Malvern Instruments Ltd has signed an exclusive distribution agreement with Affinity Biosensors LLC which will extend the range of solutions that Malvern offers to the biopharmaceutical sector.The ...
Tags: Malvern Instruments Ltd, Affinity Biosensors LLC, biopharmaceutical
Gilead Sciences, a biopharmaceutical company, has submitted a new drug application (NDA) to the FDA for HIV integrase inhibitor elvitegravir for the treatment-experienced patients. The company provided 96-week data from a pivotal Phase ...
Multi-national biopharmaceutical and diagnostics company OPKO Health has acquired Prost-Data,a Nashville-based CLIA laboratory. Prost-Data,which is doing business as OURLab,has 18 phlebotomy sites throughout the US and an experienced ...
Tags: OPKO, Prost-Data, commercial platform, acquisition
Charles River Laboratories International has completed the acquisition of a provider of cGMP-compliant contract microbial identification testing services, Accugenix, for $17m in cash. The acquisition will enable Charles River to ...
Tags: acquisition, expansion, microbial detection services, medical service
Charles River Laboratories has inaugurated a new biomedical diagnostic testing facility in Wilmington, Massachusetts, US. The 60,000ft 2 new facility will provide controlled environments, building monitoring and mechanical systems ...
pSivida, a developer of sustained release drug delivery products, has entered into an agreement with a biopharmaceutical company for the evaluation of its Tethadur protein/antibody delivery technology. Designed for use in the field of ...