No Product Is Approved for Hernia Prevention. BD Is Spending Five Years to Change That.
BD is not testing a product against a competitor. It is testing whether an indication can be brought into existence, with no label, code or precedent.
Europe
Scholar Rock Filed With Two Fill-Finish Sites. One Just Failed, and the Date Held.
Catalent Indiana failed its FDA inspection. Scholar Rock had named a second fill-finish site in the same BLA, so the PDUFA date did not move.
Sphere-9 Can Ablate VT in Europe While Its US Pivotal Is Still Enrolling
Medtronic can sell Sphere-9 into ventricular tachycardia in Europe while the trial meant to prove it works in the US is only now enrolling.
The EPO Revoked BMS’s 480mg Opdivo Patent Because the Trial Behind It Dosed by Weight
BMS claimed a 480mg flat dose. The only clinical example in its filed application dosed by weight. The EPO revoked the patent on added matter.
A. Menarini Diagnostics and Nucleix Form Strategic Partnership for Non-Invasive Bladder Cancer Test in Europe
A. Menarini Diagnostics and Nucleix have announced a strategic commercial agreement to exclusively market the Bladder EpiCheck® test in Europe. This non-invasive, CE-marked urine test is designed to detect and monitor bladder cancer and upper tract urothelial carcinoma (UTUC), providing an alternative to invasive cystoscopy. The partnership was revealed at the 36th European Congress of … Read more