Cornerstone Pharmaceuticals has received the US Food and Drug Administration (FDA) orphan drug designation for its altered energy metabolism directed (AEMD) drug candidate 'CPI-613' for treatment of myelodysplastic syndrome (MDS). MDS is ...
Japanese pharmaceutical firm Eisai has secured approval from the European Commission (EC) on the license extension application for the use of antiepileptic agent Zonegran (zonisamide) in the treatment of pediatric patients. The EC ...
Tags: Eisai Obtains, Zonegran
The US Food and Drug Administration (FDA) has approved US-based StemCells’ investigational new drug (IND) application for clinical testing of its HuCNS-SC human neural stem cells as a treatment for spinal cord injury. StemCells is ...
Tags: Spinal Cord Injury, Medicine
Canadian regulatory authority Health Canada has approved Valeant Pharmaceuticals International subsidiary Valeant Canada's new drug submission of Jublia for the treatment of onychomycosis. Jublia is designated for the treatment of mild to ...
Tags: Fungal Drug, Medicine
The retail sector is going through profound changes in Canada. There have been a number of recently announced high profile mergers and acquisitions (Loblaw purchases Shoppers Drug Mart; Sobey's buys Canada Safeway, Hudson's Bay buys Saks) ...
Tags: Transportation, Auto Parts
TVA Medical, a medical device company focused on endovascular innovation, has announced that its vascular catheter-based Flex system for hemodialysis access has demonstrated success in the FLEX-1 pilot study. Recently, the company ...
Tags: TVA Medical, Medicine
Biopharmaceutical company Trigemina will deliver clinical data on its drug candidate TI-001 for the treatment of chronic migraine at the ongoing 7th Annual Pain Therapeutics Summit East in Boston, Massachusetts. The presentation will ...
Tags: Migraine Drug, Medicine
Beckman Coulter, a manufacturer of biomedical laboratory instruments, has obtained the 510(k) approval from the US Food and Drug Administration (FDA) for its Access AccuTnI+3 troponin I assay for use on the UniCel DxI series of immunoassay ...
Tags: Beckman Coulter, Cardiac Disease
NovaDigm Therapeutics has started a Phase Ib/IIa clinical trial of its NDV-3 vaccine, which is being developed to prevent episodes of vulvovaginal candidiasis (VVC) in patients with recurrent VVC (RVVC). Under the trial, which is a ...
Tags: NDV-3 Vaccine, NovaDigm
CureDuchenne has launched a new drug discovery and development initiative to identify and develop a pipeline of therapies to treat Duchenne muscular dystrophy. The initiative, dubbed CureDuchenne Ventures, is based on the company's ...
US-biotechnology company Labcyte has partnered with AstraZeneca to develop acoustic sample handling for mass spectrometry to advance drug discovery applications. Biotechnology tools firm Labcyte has recently developed techniques for the ...
Tags: Labcyte Partners
PointCross Life Sciences, a PointCross company, has secured a $20m indefinite delivery, indefinite quantity (IDIQ) contract from the U.S. Food and Drug Administration (FDA) for providing software development and life cycle management of ...
Tags: PointCross, Life Sciences
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
World biggest biopharmaceutical company Amgen in terms of market cap declared the establishment of a Chinese R&D center, another important step taken after forming a JV with Zhejiang Beta Pharma in May 2013. Amgen Global Business ...
Tags: Health, Medicine, generic drugs
US-based Dynex Technologies has obtained a four year marketing approval from the State Food and Drug Administration of China for its DSX automated enzyme-linked immunosorbent assay (ELISA) processing system in China. The DSX ELISA ...
Tags: Dynex, Elisa Processing System