CLINICAL Data has released the complete results from its first Phase III study of vilazodone as a potential treatment for major depressive disorder.
12/03/2009
The US Food and Drug Administration (FDA) A has finalised a paper titled 'Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects', which includes an attachment specifically for those involved in medical device trials and their management.
05/11/2009
NOVABAY Pharmaceuticals has announced preclinical animal data showing that NVC-422, the company's lead Aganocide compound, was effective in treating subcutaneous dermatophyte (skin fungus) infections.
16/03/2009
VENTRACOR says its US Bridge to Transplant (BTT) trial of its VentrAssist Left Ventricular Assist Device (LVAD) was successfully completed.
17/03/2009
THE FDA advisory committee have met to discuss the new drug application (NDA) for Bayer’s rivaroxaban.
25/03/2009
CHEMIMAGE has announced it will aid generic drug makers achieve bioequivalence for nasal spray suspensions and inhalation products by providing a faster and more accurate way to determine drug particle size distribution in a drug product.
20/03/2009
The Therapeutic Goods Administration (TGA) has approved for registration the Australian-made Panvax H1N1 Vaccine Junior enabling children from 6 months to 9 years of age to be protected against the pandemic H1N1 influenza.
04/12/2009
The first five Phase III studies by Roche confirm taspoglutide, a human GLP-1 analogue, reduces blood glucose compared with other diabetes treatment options.
16/02/2010
A network of hospitals in the UK have implemented a chemotherapy software solution that enables patients to become more involved in managing their own care.
24/02/2010
RESEARCHERS at Stanford University have published a comprehensive model representing the medical device development process, in an effort to help companies execute the bench-to-bedside process of product development.
02/07/2009
US researchers report that the 2009 H1N1 Influenza virus can damage cells throughout the respiratory airway, as discovered from autopsies of fatal cases. The damage seen is much like that of earlier influenza pandemics in 1918 and 1957.
11/12/2009
Roche has announced the latest results of its Phase III clinical trial, CLL8, involving MabThera/Rituxan. The study compared MabThera/Rituxan with two different chemotherapy regimens as first-line treatment of patients with advanced follicular, indolent and mantle cell lymphomas.
10/12/2009
GlobalData has released its latest study's findings titled "Europe Picture Archiving and Communication Systems (PACS) Market: Market Analysis and Opportunity Assessment".
15/01/2010
Menveo, a quadrivalent meningococcal conjugate vaccine from Novartis, has been approved by the US Food and Drug Administration (FDA) for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in people 11 to 55 years of age.
01/03/2010
SCHERING-PLOUGH today announced that the US Food and Drug Administration (FDA) has approved new labelling for its PEGINTRON (peginterferon alfa-2b) and REBETOL (ribavirin, USP) combination therapy for treating chronic hepatitis C in patients three years of age and older with compensated liver disease.
16/03/2009
The Queensland Paediatric Cardiac Service (QPCS) at Mater Children’s Hospital has registered Australia’s first paediatric cardiac patient in a remote monitoring system that allows patients with implanted cardiac devices to be examined over the internet.
15/12/2009