Progress being made with UK clinical trials metrics
Monday, 11 April 2016 15:21
This report on UK Clinical Trials has been sent out to UKTI and FCO/BIS Science & Innovation Network colleagues by Professor Chris Whitty, Chief Scientific Advisor at the Department of Health. This follows the previous report sent out in March 2015 by Dame Sally Davies. The report presents data from a variety of sources showing that the UK is increasing its volume of research, patient recruitment, speed of study set up and European competitiveness.
Promising new blood test is first of its kind to detect liver scarring
Monday, 11 April 2016 09:50
via ScienceBlog.com Newcastle scientists and medics have developed a new type of genetic blood test that diagnoses scarring in the liver – even before someone may feel ill. It is the first time an epigenetic signature in blood has been discovered which is diagnostic of the severity of fibrosis for people with Non-alcoholic Fatty Liver Disease (NAFLD). Read the full story.
FDA approves Inflectra, a biosimilar to Remicade
Monday, 11 April 2016 09:18
On 5 April, the U.S. Food and Drug Administration (FDA) approved Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This is the second biosimilar approved by the FDA. Inflectra is biosimilar to Janssen Biotech, Inc.’s Remicade (infliximab), which was originally licensed in 1998. In the United States, Inflectra is approved and can be prescribed by a health care professional for the treatment of:
- adult patients and pediatric patients (ages six years and older) with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy
- adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy
as well as for several rheumatological conditions. The American College of Rheumatology responded to the announcement, welcoming the approval, and emphasised that "the safety of our patients remains our highest priority. As such, we encourage the FDA to continue to apply distinct names for future biosimilars, and to maximize clarity in the labeling of biosimilars, specifically with respect to their interchangeable status and the origins (reference drug versus biosimilar) of clinical data upon which FDA approval is based."
The American College of Rheumatology (ACR) had welcomed the FDA’s draft guidance (August 2015) recommending that biosimilars are clearly differentiated from their reference drugs. The ACR has been calling on the FDA to introduce stricter authorisation and labelling measures for biologics, issuing a position statement "on biosimilars that updates and clarifies the ACR’s positions on extrapolation, substitution, notification and labeling. More details are available from both the ACR and the Office of the Federal Register.
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