EMEA Gives Official Scientific Advice On Clinical Phase IIb Efficacy Study Of Inecalcitol In Hormone-refractory Prostate Cancer
Hybrigenics, a bio-pharmaceutical company with a focus on research and development of new cancer treatments and specialized in protein interactions, announced that it has received the official scientific advice from the European Medicines Agency (EMEA) on Hybrigenics' clinical development plan for inecalcitol in hormone-refractory prostate cancer patients. EMEA's recommendations back the protocol proposed by Hybrigenics and will facilitate authorizations by national health agencies in each European country where the Phase IIb clinical trial of high doses of oral inecalcitol in addition to intravenous cycles of Taxotere(R) will be implemented.
Recordati : Silodosin Approved By The European Commission For The Treatment Of The Signs And Symptoms Of Benign Prostatic Hyperplasia
Recordati announces that it has been granted Marketing Authorization by the European Commission for the medicinal products Urorec® and Silodyx™ 4 mg, 8 mg, hard capsules, intended for treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Following national post-authorization procedures, as relevant, product launch could take place by end 2010 or beginning 2011. Benign prostatic hyperplasia (BPH, enlargement of the prostate) is characterized by urination difficulties such as weak urine stream, increased frequency and urgency, nocturia. The prevalence of this condition is increasing due to the progressive ageing of the male population.
Launch Of Ipsen's Decapeptyl 6-Month Formulation LP 22.5 Mg In France For The Treatment Of Advanced Or Metastatic Hormone-Dependent Prostate Cancer
Ipsen (Paris:IPN), an innovation-driven global specialty pharmaceutical group and Debiopharm Group (Debiopharm), a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs, announce the launch by Ipsen in France of Decapeptyl® LP 22.5 mg 6-month sustained-release formulation for the treatment of locally advanced or metastatic hormone-dependent prostate cancer. Other launches are planned shortly, notably in Germany and Portugal. The marketing authorization (MA) to this 6-month sustained-release formulation of Decapeptyl® (triptorelin embonate1 22.
The commonly-used painkiller Paracetamol can protect against kidney failure after severe muscle injury, according to research at the University of Essex. One of the main causes of kidney failure affecting tens of thousands of people each year is a syndrome known as Rhabdomyolysis-Induced Renal Failure. Common causes of this condition include trauma or crushing injuries, drug abuse and intensive exercise. Now, an international team of scientists, involving researchers at Essex, University College London and the USA, has discovered that Paracetamol reduces the damage caused to kidneys following severe muscle injury. The team at Essex is led by Professor Mike Wilson and Dr Brandon Reeder from the Department of Biological Sciences.
DSG's eCaseLink™ Electronic Data Capture (EDC) and data management are currently being used by a biotechnology company for two current phase 2 and phase 2a clinical trials for treatments of progressive and chronic kidney disease. The company uses DSG's eCaseLink™ to automate and manage the data collection process during the clinical trial lifecycle. In addition, DSG combines data management services with eCaseLink™ to seamlessly optimize data collection and analysis. The result is clean clinical trial data, collected and analyzed efficiently. This accelerates the clinical trial process, helping to safely speed these treatments to those who need them.
Vantia Therapeutics, an emerging pharmaceutical company developing novel, small molecule drugs targeting large, underserved medical markets, announces it has begun its planned Phase IIb trial of its lead development compound VA106483 for nocturia. The study is a randomised, double-blind, placebo-controlled study and is expected to recruit approximately 120 male patients at 20 centres in the US. The study will primarily assess number of nocturnal voids per night. Secondary endpoints include quality of life and sleep duration measures. Nocturia (defined as waking to urinate at night thereby significantly disturbing sleep) is a common condition, with prevalence increasing markedly with age.