1. Pfizer’s Amsparity (biosimilar, adalimumab) Receives CHMP’s Positive Opinion for Inflammatory and Autoimmune Disorders Published: Dec 12, 2019 | Tags: Pfizer, Amsparity, biosimilar, adalimumab, Receives, CHMP, Positive Opinion, Inflammatory, Autoimmune […]readmore
Tags : Vertex
Shots: The EC’s approval is based on P-III ARRIVAL open-label safety study assessing Kalydeco in children with CF aged < 24mos. with CFTR gating mutation, demonstrated similar safety profile as […]readmore
Shots: The two P-I/ II studies, CLIMB-Thal-111 & CLIMB-SCD-121 studies will assess CTX001 in patients with transfusion-dependent beta-thalassemia & sickle cell disease aged 18-35yrs. and enrolls up to 45 patients […]readmore
Shots: Molecular Templates (MTEM) to receive $38M up front including an equity investment, up to $522M as development, regulatory, commercial milestones, option payment for two targets and royalties on sales […]readmore
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. 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 two P-III studies involve assessing of Trikafta in 403 & 107 patients aged ≥12yrs. with CF with one F508del mutation and one minimal function mutation (F/MF) in the […]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: The agreement allows CF patients aged ≥2yrs.with two copies of F508del mutation in CFTR gene to access Orkambi (lumacaftor/ivacaftor) and CF patients aged ≥12yrs. with either two or one […]readmore
Regulatory
Vertex’s Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) Receives the US FDA’s Approval
Shots: The approval is based on two global P-III studies assessing Trikafta in 403 & 107 patients with CF aged ≥12yrs. with at least one F508del mutation and one minimal […]readmore