ERYtech Pharma : last patient for its Phase II GRASPALL clinical trial

May 15th 2008 - ERYtech Pharma, a French biotechnology company, announces the inclusion of its last patient in its Phase II clinical trial for relapsed Acute Lymphoblastic Leukaemia (ALL).
The main goal of this trial is to evaluate the pharmacokinetic, the pharmacodynamic and the safety of GRASPA®, ERYtech Pharma’s new medicinal product. Twenty four patients, comprised of nine adults and nine children received at least one dose of. GRASPA® three other child, and three adult patients received the control product, the free form of native E. coli L-Asparaginase... ERYtech's Press Release -

Scient'x : FDA 510(K) Clearance for Isobar DUO Dynamic Stabilization System

May 06, 2008 - Scient'x, a privately held manufacturer of innovative spinal implant technologies, announced that it has received FDA 510(k) clearance to market its new Isobar DUO™ Dynamic Stabilization System. This system is an extension of the original Isobar Dynamic TTL-Rod® which received FDA 510(k) clearance in 1998. The Isobar Duo™ has been cleared to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment; fracture, dislocation, scoliosis, kyphosis, spinal tumor; and failed previous fusion. The development of this system originated directly from surgeon requests to utilize the Isobar Dynamic TTL-Rod® technology at multiple levels. With the Isobar Duo™, the surgeon is able to utilize a standard 5.5mm diameter rod with two unique dampener elements that provides controlled motion for use at two levels... Scient'x's Press Release -

Sanofi-aventis : Phase III Results for Eplivanserin

April 30, 20008 - ... Eplivanserin : Sanofi-aventis announced today that the GEMS Phase III study shows that the 5-HT2A antagonist eplivanserin in development for the treatment of insomnia characterized by sleep maintenance difficulties/night- time awakenings significantly reduces WASO (Wake time After Sleep Onset) and the number of night-time awakenings reported by the patient at 6 and 12 weeks of treatment, versus placebo. An improvement of the quality of sleep was also observed in the study.These results confirm those of the EPLILONG study (phase III study conducted in similar conditions), which also showed that eplivanserin significantly reduces WASO and the number of night-time awakenings reported by the patient at 6 and 12 weeks, versus placebo and improves the quality of sleep... [PDF] Sanofi-aventis' Press Release - PDF du Communiqué de Presse de Sanofi-Aventis -

NOVAGALI PHARMA : First Patient in U.S. Phase I Clinical Study with CORTIJECT for Diabetic Macular Edema

April 24th, 2008 - Novagali Pharma, an emerging ophthalmic pharmaceutical company today announced that it has successfully injected the first patient in a Phase I clinical trial using CORTIJECT®, an ophthalmic injectable emulsion based on EYEJECT® technology platform containing a corticosteroid prodrug for the treatment of Diabetic Macular Edema (DME). This trial, which will enroll a total of 15 patients, is designed to evaluate the safety and to observe the efficacy trend of CORTIJECT®. The patients will be monitored for a period of twelve months following injection... Novagali Pharma's Press Release - Communiqué de Presse Novagali -

Ondalys : involved in the DIAdvisor project (Personal Glucose Predictive Diabetes Advisor)

29-10-2007 - Ondalys is involved in the DIAdvisor project (Personal Glucose Predictive Diabetes Advisor), which has just been selected by the EU to receive 7.1 millions Euros during 4 years, in the 1^st call of the 7^th European FrameWork Program.
The DIAdvisor™ is a large scale integrating project (IP), involving 13 European partners, within the fields of physiological modeling, identification theory, control theory, medical device technology, risk management theory, sensor science and user understanding...Ondalys' Press Release -