InSightec has received approval from the Chinese Food and Drug Administration (CFDA) for its ExAblate system designed to treat uterine fibroids non-invasively. This system uses high intensity focused ultrasound energy to destroy the ...
Tags: InSightec, Ultrasound System
NeuroSigma has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to begin a Phase III pivotal trial of its Monarch eTNS System. Designed to treat the drug resistant epilepsy, the ...
Tags: Device Trial, NeuroSigma
The European Commission has granted orphan drug designation to BrainStorm Cell Therapeutics’ stem cell therapy NurOwn to treat Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's Disease. NurOwn consists of autologous ...
Tags: Orphan Drug, Medicine
Depomed has acquired US and Canadian rights to Archimedes Pharma’s Lazanda (fentanyl) nasal spray for $4m in cash for pain management in cancer patients (BTPc) 18 years of age and older. Leveraging Archimedes patented PecSys drug ...
Tags: Pharma's Lazanda, Medicine
IntelligentMDx has secured clearance from the US Food and Drug Administration (FDA) for IMDx VanR for Abbott m2000 assay, an automated molecular diagnostic test that detects the presence of vanA and vanB genes associated with ...
Canadian manufacturer of over-the-counter (OTC) pharma products Vita Health has announced the recall of three lots of its Compliments Iron Ferrous Gluconate tablets in consultation with Health Canada, over labeling issue. At least one ...
Tags: OTC Tablets, Labeling Issue
EnteroMedics has submitted premarket approval (PMA) application to the US Food and Drug Administration (FDA) for Maestro Rechargeable System's VBLOC, a vagal blocking therapy to treat obesity. Maestro RC system delivers vagal blocking ...
Tags: EnteroMedics, Vbloc Therapy
Researchers at A*STAR’s Genome Institute of Singapore (GIS) have identified potential targets for therapeutic drugs against aggressive breast cancer. Working in collaboration with local and international institutions, GIS scientists ...
Tags: therapeutic drugs, Medicine
Daiichi Sankyo Company has decided to expand its collaborative drug discovery program with universities and research institutions based in Japan, Take a New challenge for Drug diScovery (TaNeDS) Global Program, to Germany, Switzerland and ...
Tags: Daiichi Sankyo, Medicine
Dr Reddy's Laboratories, an India-based pharmaceutical company, has introduced Donepezil Hydrochloride tablets 23mg in the US on 26 July 2013. The launch follows the approval of an abbreviated new drug application (ANDA) for the drug by ...
Tags: Drug Aricept, Generic Equivalent
British drug-maker GlaxoSmithKline (GSK) has reached settlement with the attorneys general of eight US states over misleading marketing of the diabetes treatment drug, Avandia, and even agreed to pay $229m to settle the lawsuits. Without ...
Tags: Avandia Lawsuits, Medicine
US-based dispensing systems supplier AptarGroup has announced plans to invest $26m to increase the capacity of its Aptar Stelmi pharma packaging business, which was acquired in July 2012. The investment will be used to expand facilities, ...
Tags: Aptargroup, Pharma Packaging
Contract service organization SGS Life Science Services has selected Merge eClinical OS to optimize data management across Phase I-IV studies. With flexibility to support trials in any phase, capture any type of data, from any source and ...
Tags: SGS, Phase I-IV Studies
Hologic's Aptima HPV assay has received clearance from the US Food and Drug Administration (FDA) for use on its fully-automated Panther system, enabling laboratories to run multiple tests from a single specimen. A nucleic acid amplified ...
Tags: Panther System, Aptima HPV Assay
Imprimis Pharmaceuticals has received approval from the Institutional Review Board (IRB) to initiate Phase III clinical trial protocol of its new topical non-steroidal anti-inflammatory drug (NSAID) candidate, Impracor. Impracor is based ...