Regulator says too many drugmakers chasing same cancer strategy Reuters reports that Dr. Richard Pazdur, who heads the Food and Drug Administration’s office of oncology products, believes that?too many companies are focused on PD-1 inhibitors for?cancer immunotherapy. Whereas PD-1 inhibitors show promise for remarkable efficacy, Dr. Pazdur is reportedly concerned that?too many companies are[…]
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[…]