Biosimilar Switching Not Suitable For All Patients 100% of patients?who developed antibodies to?innovator anti-TNF-? exhibited antibody reactivity against the biosimilar. ?Study results cast?doubt on interchangeability. 8 June 2016 According to a report from European League Against Rheumatism Annual Congress (EULAR) 2016, patients with antibodies to biological infliximab are less likely to benefit from infliximab biosimilar[…]
Theravance Biopharma Reports Positive Results From Phase 1 Clinical Trial of a GI-Targeted Pan-Janus Kinase (JAK) Inhibitor TD-1473 showed a reduction in plasma exposure compared to?currently-approved JAK inhibitor. On June 9, 2016, Theravance Biopharma released positive results from a completed Phase I clinical trial of TD-1473, its oral GI-targeted pan-Janus kinase (JAK) inhibitor. TD-1473 is[…]
Looking More Closely at Lewy Body Dementia University of Michigan Health Lab recently posted an article about the?3rd most common form of dementia, Lewy Body Dementia, which is?frequently-misdiagnosed as Alzheimer’s. The article provided a good overview of Lewy Body Dementia, outlined what doctors and patients need to know, and described advancements in fighting[…]
Meaningful suffix may be in for U.S. biologics, biosimilars FDA Pushes Back Comment Period for Biosimilar Labeling Just released: new deadline August?2 for information collection request it submitted to the White House Office of Management and Budget (OMB) Additional Reading FDA approves Inflectra, a biosimilar to Remicade A Rocky Start for[…]
http://www.projectmanagement.com/articles/331859/Planning–Assessing–Analyzing-and-Monitoring-Country-and-Political-Risk-During-the-PMI-Risk-Management-Process High Risk Ahead? Project outcomes are better in organizations that invest in ongoing project management training High cost of poor project performance: $122mil for every $1B invested. More investment in PM essential to org health Robust risk management strategy must include project management component Organizations waste US$122 million for every US$1 billion invested[…]