$110B market: excessive spending on me-too PD-1 drugs?

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: new evidence against interchangeability

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[…]

GI-targeted oral JAK inhibitor shows promise in Phase I Study: TD-1473

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[…]

Dementia, yes, but this is not Alzheimer?s

  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[…]

Biosimilar nomenclature: Deadline August 2 for comments on FDA’s OMB information request

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[…]

Companies waste $122 million for every $1B – need greater investment in project management

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[…]

Genetically modified T-cell therapy granted enhanced EMA regulatory pathway: KTE-C19

Kite Pharma granted access to PRIME regulatory support for KTE-C19 to treat chemorefractory DLBCL In a press release, Kite Pharma announced that it is?among first sponsors selected to participate in the EMAs enhanced regulatory program for investigational therapies that promise significant advances against serious diseases. ?The?European Medicines Agency (EMA) Committee for Medicinal Products for Human[…]