US-based XOMA Corporation (XOMA) has received Orphan Drug Designation from the US Food and Drug Administration (FDA) for its IL-1 beta modulating antibody 'gevokizumab' for the treatment of pyoderma gangrenosum (PG). Gevokizumab is a ...
Tags: Orphan Drug, Medicine
Duke University’s Duke Clinical Research Institute (DCRI) has been selected by Oxygen Biotherapeutics, a pharmaceutical company, to conduct the Phase III clinical trial of the company’s newly acquired compound, levosimendan. ...
Boston Scientific has reported favorable results assessing real-world experience with the Precision Spectra spinal cord stimulator system. New retrospective data highlighting the Boston Scientific Precision Spectra spinal cord stimulator ...
BioDelivery Sciences International (BSDI) announced that it engaged in a positive meeting with the US Food and Drug Administration (FDA) regarding the clinical development program for Clonidine topical gel that will allow the program to ...
Discovery Laboratories, a specialty biotechnology company dedicated to advancing a new standard of respiratory critical care, has announced that the US Food and Drug Administration (FDA) has cleared the company's investigational new drug ...
Tags: Discovery Labs, Medicine
H Lundbeck has expanded its current alliance with Otsuka Pharmaceutical (Otsuka) to include development and commercialization of nalmefene in Japan. Earlier in 2013, nalmefene was approved by the European Medicines Agency (EMA) as the ...
Tags: Lundbeck, Otsuka Pharmaceutical
US-based Loxo Oncology has announced that its lead clinical program is a potent and selective inhibitor of the Trk family of receptor tyrosine kinases. Loxo Oncology acquired rights to this program from Array Biopharma, which had pursued ...
Tags: Loxo Oncology, Medicine
Alzheon announced the launch of the company, the securing of initial private financing, and the signing of an exclusive license agreement to a novel clinical drug candidate for Alzheimer’s disease, a family of analogs, and a drug ...
Tags: Alzheon, Alzheimer's Disease
Israel-based Cardiosonic announced it is currently enrolling patients in the TIVUS II clinical trial, designed to assess the safety, efficacy and performance of its TIVUS system using a next generation multidirectional catheter. TIVUS ...
Tags: Cardiosonic, Clinical Trial
Collegium Pharmaceutical, a specialty pharmaceutical company, has announced that a patent has been issued by the US Patent and Trademark Office (USPTO) covering its Oxycodone DETERx formulation. Additionally, an application has been ...
Danish pharmaceutical firm Novo Nordisk has received biologics licence application (BLA) approval from the US Food and Drug Administration (FDA) for its recombinant coagulation factor VIII, Novoeight. Novoeight is intended for adults and ...
Tags: Novo Nordisk, Drug
The US Food & Drug Administration (cof Orphan Product Development has granted orphan drug designation for Lumena Pharmaceuticals' LUM001 clinical program. Lumena obtained orphan designation for LUM001 in four rare cholestatic liver ...
Tags: Orphan Drug, Rare Liver Diseases
Danish pharmaceutical company Novo Nordisk has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing approval for its NovoEight (turoctocog alfa), ...
Tags: Novo Nordisk, Novoeight
HMS Holdings wholly owned subsidiary has launched HMS IntegritySource payment integrity suite for commercial and government healthcare payers. Aimed to deliver 'one data source, many solutions', HMS IntegritySource's key components ...
Tags: HMS, Healthcare Payers
Medtronic has submitted its first pre-market approval (PMA) module to the U.S. Food and Drug Administration (FDA) for the IN.PACT Admiral drug-eluting balloon designed to treat atherosclerotic lesions in the superficial femoral artery ...
Tags: Medtronic, Admiral Drug-Eluting