Shots: The US FDA’s approval is based on SUSTAIN study assessing Adakveo (5mg/kg, 2.5mg/kg) vs PBO in 198 patients in a ratio 1:1:1 aged ≥ 16yrs. with any genotype of […]readmore
Tags : Novartis
The US FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 35 new products so far in 2019. In 2018 FDA […]readmore
1. Triumvira’s TAC01-CD19 Receives FDA’s Fast Track Designation for R/R Diffuse Large B-Cell Lymphoma Published: Nov 07, 2019 | Tags: Triumvira, TAC01-CD19, Receives, FDA, Fast Track Designation, R/R, Diffuse Large B-Cell […]readmore
1. Medtronic Reports MHLW’s Shonin Approval and Launches Valiant Navion Thoracic Stent Graft System in Japan Published: Oct 31, 2019 | Tags: Medtronic, Reports, MHLW, Shonin Approval, Launches, Valiant Navion Thoracic […]readmore
Shots: The P-III EXCEED study involves assessing Cosentyx (300mg) vs Humira (adalimumab, 40 mg) in 800+ biologic-naïve patients with PsA for 52wks. The P-III EXCEED results: Cosentyx narrowly missed statistical […]readmore
Shots: The partial hold on clinical study for intrathecal administration of AVXS-101 follows the findings of the pre-clinical study demonstrated dorsal root ganglia (DRG) mononuclear cell inflammation accompanied by neuronal […]readmore
Shots: The discontinuation of a clinical program is based on an interim analysis for futility in P-II IGUANA study which demonstrated low probability to meet 1EPs i.e, the percentage change […]readmore
1. Urology San Antonio Collaborates with Anixa Biosciences on Ccheck Prostate Cancer Study Published: Oct 25, 2019 | Tags: Urology San Antonio, Collaborates, Anixa Biosciences, Ccheck, Prostate Cancer Study 2. NHS […]readmore
Shots: Pliant to receive $80M including upfront & equity investment and eligible to receive development, regulatory and commercial milestones with royalties on sales. Novartis to get exclusive WW license for […]readmore
OraSure Technologies’ Rapid Diagnostic OraQuick Ebola Rapid Antigen Test Receives the US FDA Marketing Approval for Detection of Ebola Virus Antigens Published: Oct 10, 2019 | Tags: Diagnostic, Oraquick Ebola Rapid […]readmore