Tags : Regenxbio

PharmaShots Weekly Snapshot (Sept 07 -11, 2020)

1. Janssen’s Tremfya (guselkumab) Receives the US FDA’s Approval as the First Selective IL-23 Inhibitor for Active Psoriatic Arthritis Published: Sept 10, 2020 | Tags:  Janssen, Tremfya, Guselkumab, Biologic, US FDA, Selective, IL-23 inhibitor, Active Psoriatic Arthritis, Severe Plaque Psoriasis, human mAb 2. Janssen Reports sBLA Submission to the US FDA for Darzalex Faspro (daratumumab […]Read More

Regenxbio Reports First Patients Dosing in its P-II AAVIATE Study

Shots: The first patient has been dosed in the P-II AAVIATE trial to assess the suprachoroidal delivery of RGX-314 (2.5×1011 GC/eye & 5×1011 GC/eye) vs ranibizumab (0.5mg, monthly, IVT) using the SCS Microinjector in ~40 patients in a ratio (3:1) with wet AMD The 1EPs of the study is mean change in vision in patients […]Read More

PharmaShots Weekly Snapshot (September 02 – 06, 2019)

1.Roche’s Tecentriq + Chemotherapy Receives EC’s Approval as 1L Treatment for Extensive Stage Small Cell Lung Cancer Published: Sept 06, 2019 | Tags: Roche, Tecentriq, Chemotherapy, Receives, EC, Approval, Initial Treatment, Extensive Stage Small Cell Lung Cancer 2. OncoCyte to Acquire Razor Genomics for the Expansion of its Capabilities in Early-Stage Lung Cancer Published: Sept 05, 2019 […]Read More

Regenxbio Signs an Exclusive Worldwide Option and License Agreement with

Shots: Clearside to receive ~$34M as development milestones, ~$102M commercial milestones, option exercise fee and royalties on sales of product utilizing SCS microinjector. Regenxbio to get an option to receive an exclusive WW commercial license with rights to sublicense Clearside’s SCS microinjector to deliver AAV gene therapies for wet AMD, DR and other chronic anti-VEGF […]Read More

Pfizer Signs a License Agreement with Regenxbio for its NAV

Shots: Regenxbio to receive up front, development and commercial milestone and royalties on sales of products. Pfizer to get non-exclusive WW license with rights to sublicense Regenxbio’s NAV AAV9 vector to develop & commercialize gene therapies for Friedreich’s ataxia The focus of the agreement is to strengthen Regenxbio’s intellectual property portfolio and the potential of NAV […]Read More

Regenxbio Signs an Exclusive Development and Commercialization Agreement with Neurimmune

Shots: Regenxbio and Neurimmune enter into a collaboration to develop vectorized Ab by combining antibodies identified using Neurimmune’s reverse translational medicine platform with Regenxbio’s NAV technology platform for chronic neuro-degenerative diseases including tauopathies The companies will jointly develop & commercialize AVV gene therapies with equal development cost-sharing with an initial focus on tauopathies. Following initial […]Read More

REGENXBIO Launches a Manufacturing Facility for Developing Gene Therapies Based

Shots: REGENXBIO plans to construct a cGMP manufacturing facility in Rockville, Maryland to produce gene therapy vectors based on NAV technology at scales up to 2,000L using its platform suspension cell culture process The addition of new cGMP manufacturing facility complements current external manufacturing capabilities, enabling a supply of NAV vectors from both internal and […]Read More

RegenxBio and Rocket Signs Exclusive Worldwide License Agreement for NAV

Shots: RegenxBio to receive $7M upfront, milestones payments plus royalties on net sales. Rocket to get exclusive worldwide rights for RegenxBio’s NAV AAV9 Vector to develop and commercialize gene therapies for Danon disease Rocket also has exclusive option to add two additional NAV AAV vectors for Danon disease, for duration of four years REGENXBIO’s NAV […]Read More