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[…]
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[…]
Inventing A Machine That Spits Out Drugs In A Whole New Way A laboratory at Massachusetts Institute of Technology (MIT) in conjunction with Novartis have a prototype device?that produces 1,000 pills in 24 hours, according to a collaborative report from?NPR, WBUR and Kaiser Health News. ? The article goes on to say that the[…]
I read with interest the recent article from the Voices on Project Management Blog,?How to Avoid Useless Meetings?and?offer some additional thoughts below. In addition to a having an?agenda that includes the details the article describes, you?should distribute the agenda at least 24 hours in advance. ?Sometimes that will mean last-minute adjustments might?be necessary, so plan[…]