US FDA APPROVES NANOBIOTIX’S FIRST IMMUNO-ONCOLOGY TRIAL: A PHASE I/II STUDY OF NBTXR3 ACTIVATED BY RADIATION THERAPY (SABR) FOR PATIENTS WITH NON-SMALL CELL LUNG CANCER OR HEAD AND NECK SQUAMOUS CELL CARCINOMA CANCER TREATED WITH AN ANTI-PD1 ANTIBODY (NIVOLUMAB OR PEMBROLIZUMAB)   First Nanobiotix immuno-oncology trial will be conducted in the U.S. Multi-arm trial targets […]

ICER: CAR T THERAPIES ARE PRICED RIGHT BY MARY ROMEO December 21, 2017 The Institute for Clinical and Economic Review (ICER) believes the first two FDA-approved chimeric antigen receptor (CAR) T cell therapies — Kymriah tisagenlecleucel and Yescarta axicabtagene ciloleucel — are priced in-line with their clinical benefits over a lifetime, given currently available evidence. […]

The top 10 prospective blockbuster drug launches slated for 2018 according to Evaluate   by john carroll — on December 14, 2017 08:09 AM EST   Every­body in bio­pharma talks about unmet med­ical needs when they re­view their late-stage pipeline, but it’s the mar­ket po­ten­tial that will ei­ther whip up in­vestors or leave them cold about any in­no­va­tion. The […]

Advancing Policies to Promote Safe, Effective MedTech Innovation   Posted on December 11, 2017 by FDA Voice   By: Scott Gottlieb, M.D. Advanced technologies, biomaterials and digital tools are offering us fundamentally better ways to develop new medical devices to advance human health. To build on these innovations and ensure patients have access to safe and effective advances […]

December 13, 2017 Matthias Blamont (Reuters) Sanofi CEO Oliver Brandicourt says expect nine regulatory submissions for new drugs over the next 18 months   French pharmaceuticals group Sanofi said on Wednesday it had suffered from low uptake for a new cholesterol drug and from concerns about a dengue vaccine, but expressed confidence its pipeline of new products […]

December 13, 2017 Servier and Pfizer's CAR-T candidate licensed from Cellectis shows positive effect in two early-stage leukemia studies. Preliminary results were presented at ASH in Atlanta.       Preliminary results from two Phase 1 clinical trials assessing Servier and Pfizer's CAR-T candidate, UCART19, in leukemia patients showed a treatment effect. The first study, CALM, is […]

  Btobioinnovation.com     Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation,   jcm@btobioinnovation.com     Editor’s Note   In June of this Year we have announced the cessation of the weekly editing of the Biopharmaceutical Newsletter but you can still find valuable and updated information on your website: www.btobioinnovation.com under the News heading.   You will find […]