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Halting A Pandemic: NIH Mounts Search For A Vaccine
Bracing for an outbreak of 2009 H1N1 (swine-origin) flu that a Saint Louis University infectious diseases expert estimates could sicken one in five people this fall, scientists at eight Vaccine and Treatment Evaluation Units funded by the National Institutes of Health (NIH) are launching a series of clinical trials this summer to test vaccines to protect against the illness.
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Long Term Care Insurance Receives Attention
Congress is turning its" attention to long-term care insurance producing information about how such insurance may help consumers make informed decisions for their long-term care needs.
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Inexpensive TENS Unit Can Ease Labor Pain
There are many ways to deal with the pain of giving birth, but women and their obstetricians can always benefit from having another choice. A Cochrane review has concluded that women in labor should have the option of using transcutaneous electrical nerve stimulation (TENS) a non-drug method of pain management.
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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