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[…]

MIT-Novartis prototype produces 1,000 pills in 24 hours

  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[…]

Secret Sauce for Productive Meetings

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[…]

Pipeline biosimilar for asthma meets primary endpoint in P2/3 study

In Brief Biosimilar News reports that Sorrento’s experimental anti-IgE biosimilar, STI-004, met it’s primary endpoint in a 32-week, Phase 2/3 study conducted in China. ?Patients who received?STI-004 experienced?asthma exacerbation at a lower rate than those who received placebo: ?21% vs?55%. According to the Sorrento press release, the patient population included both?adult and adolescents suffering from[…]

Medication reminders via “smart” bottle cap and app – utilization in clinical research?

Smart Bottle?Pharmacy Delivery Service According to a new report in Forbes, the start-up,?Circadian Design, has?innovated medication, vitamin, and refill reminders by combining a few old ideas. ?The new service is called?Round Refill?and?the reminders are generated?via a connection between a medication?bottle cap and?an app on your mobile.??   Pre-Ordering Available Business Wire is reporting that “Round[…]