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Recent Survey Suggests Complications With Permanent Fillers - 1 In 4 UK Surgeons Have Seen Patients With Complications
A new survey completed by the British Association of Aesthetic Plastic Surgery (BAAPS) suggests that patients may experience higher complication rates with permanent cosmetic fillers than with other types of cosmetic injections. The survey reveals 38.5% of surgeons saw 1-3 patients over the past year experiencing complications with permanent facial fillers, and 23% of surgeons saw 1-3 patients in the past year with complications so severe surgery was needed to treat those complications. "Permanent fillers present challenges, particularly for inexperienced injectors," says Coalition leader Julius Few, MD, a plastic surgeon practicing in Chicago, IL. "In addition to potential complications that may develop years after injection, the challenge of a permanent, synthetic filler is the anticipation of aging changes and the need for outcomes that will not look unnatural over time. To date, fat continues to be the option closest to a permanent filler with a proven safety record."

Phase II Trial Of ASA404 Published In Lung Cancer
Antisoma plc (LSE: ASM; USOTC: ATSMY) announces that the journal Lung Cancer has published the results of a single-arm phase II trial of ASA404 in non-small cell lung cancer (NSCLC). The trial included patients with both major histological forms of NSCLC: squamous and non-squamous. Positive data from this trial supported the progress of ASA404 into phase III trials in patients with NSCLC of all histologies.
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Green Paper Funding Proposals "Disastrous" For People With Mental Health Problems
People with mental health problems could find themselves without adequate help and support under proposals set out in today"s green paper on adult social care, warns leading mental health charity Rethink.
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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