Shots: The EC has granted MAA to Kaftrio (ivacaftor/tezacaftor/lumacaftor) + ivacaftor (150mg) to treat people with CF aged ≥12yrs. with one F508del mutation and one minimal function mutation (F/MF), or two F508del mutations (F/F) in the CFTR gene The MAA is based on two P-III studies i.e. a 24wks. study in 403 people with one […]Read More
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 Disorders 2. Janssen’s Darzalex (daratumumab) Combination Regimen Receives CHMP’s Positive Opinion for Transplant Eligible Patients with Newly Diagnosed Multiple Myeloma Published: Dec 13, 2019 | […]Read More
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 observed in other P-III studies and showed improvement in sweat chloride as 2EPs Following the approval, children with CF in EU as young as 6 […]Read More
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 with a follow up of ~2yrs. after infusion at six clinical sites respectively The studies demonstrated a total hemoglobin level of 11.9 g/dL & […]Read More
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 of products MTEM will conduct research activities to discover a new conditioning regimen utilizing its engineered toxin body (ETB) platform for up to two targets […]Read More
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 approved 59 novel products including 42 New Chemical Entities and 17 Biologics while breaking its last year’s record of approvals. However, there is a significant […]Read More
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 Stent Graft System, Japan 2. Beam Therapeutics Signs Exclusive License Agreement with Prime Medicine for Prime Editing Technology Published: Oct 31, 2019 | Tags: Beam […]Read More
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 CFTR gene & two F508del mutations (F/F) for 24wks. & 4wks. respectively The two P-II studies resulted in meeting all 1EPs & 2EPs demonstrating significant […]Read More
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 England Signs an Agreement with Vertex to Access All Licensed Cystic Fibrosis Therapies Published: Oct 24, 2019 | Tags: NHS England, Signs, Agreement, Vertex, Access, Licensed, […]Read More
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 copy of F508del mutation and copy of one of the other 14 licensed mutations to access Symkevi (tezacaftor/ivacaftor) in combination with ivacaftor in England The […]Read More
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