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National Falls Awareness Day - 23rd June 2009
The overall aim of National Falls Awareness Day, held on the 23rd June 2009 is to raise awareness of the increased risk of falling as people age. Many of the products in Mountway"s current extensive portfolio of independent living solutions can be used to aid with falls prevention.
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Dr. Reddy's Receives Approval For Three INDs And Announces Reorganization Of Its Drug Discovery Operations
Dr. Reddy"s announced that the first human subjects were successfully dosed in a phase I study with DRL 17822, a selective inhibitor of CETP, for the treatment of dyslipidemia, atherosclerosis and associated cardiovascular diseases. The compound shows potent elevation in HDL-C and reduction of atherosclerotic plaques in animals, and has a clean safety profile in preclinical studies. The two other IND"s are for the treatment of COPD and dyslipidemia.
News of the day
Protalix Holds Pre-NDA Meeting With FDA For PrGCD For The Treatment Of Gaucher Disease
Protalix BioTherapeutics, Inc. (NYSE-Amex:PLX), announced that the Company held a pre-NDA meeting with the U.S. Food and Drug Administration (FDA). The purpose of the meeting was to discuss the a proposed new drug application (NDA) submission for prGCD, a new proprietary plant-cell expressed recombinant form of glucocerebrosidase, for the treatment of Gaucher disease and to confirm the clinical, nonclinical and chemistry requirements for the proposed NDA filing.
Medical Devices

Cimzia(R), The Only PEGylated Anti-TNF, Recommended For Approval In The EU For Rheumatoid Arthritis

UCB announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending that the European Commission grants a marketing authorisation for Cimzia® (certolizumab pegol), in combination with methotrexate (MTX), for the treatment of moderate to severe active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs (DMARDs) including MTX, has been inadequate. In these patients, Cimzia® can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. Cimzia® has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with MTX. The recommendation has been granted for Cimzia® to be administered as a subcutaneous injection using the pre-filled syringe. "The CHMP positive opinion is a significant milestone for UCB, but especially for people suffering from rheumatoid arthritis," said Roch Doliveux, Chief Executive Officer of UCB. "Cimzia® can provide an additional effective treatment option for patients with this debilitating condition, helping them to lead fuller lives." The European Commission usually delivers a European marketing authorisation subsequent to a positive CHMP opinion within three months. Following European marketing authorisation the first launches of Cimzia®, in the European Union, are anticipated before the end of 2009. The CHMP decision is supported by data from a comprehensive clinical development programme, involving more than 2 300 patients with RA and over 4 000 patient-years experience. In the pivotal clinical trials, reported serious adverse reactions, as with other anti-TNF"s, included infections (including tuberculosis) and malignancies (including lymphoma), and the most commonly occurring adverse events were upper respiratory tract infections, rash and urinary tract infections. A pooled analysis of the safety data showed a low incidence of injection site pain (1.5%) and a low level of discontinuations due to adverse events (5%). Cimzia® demonstrated a favorable risk-benefit profile in patients with at least up to two years of drug exposure. On 14 May, the U.S. Food and Drug Administration (FDA) approved Cimzia® for the treatment of adult patients with moderately to severely active rheumatoid arthritis. Cimzia UCB


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