Interim phase 1/2 data presented at Retina in Rio 2026 showed sustained visual improvements with Opus Genetics’ AAV8 gene therapy OPGx-LCA5 and improved retinal sensitivity with OPGx-BEST1 in inherited retinal diseases.
|Articles|June 15, 2016
- BioPharm International-06-15-2016
- Volume 2016 ebook
- Issue 1
Dealing with Pharmaceutical Supply-Chain Complexities
Author(s)Michael Schmitz
Planning ahead is key to enabling a continuous and secure supply chain that adapts to changes in market demand.
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The pharmaceutical supply chain faces many changes, and service providers have to accept changes in market demand and adapt to the circumstances accordingly. Experienced contract
development and manufacturing organizations (CDMOs) can offer answers to the challenging supply chain and deliver high product quality.
Articles in this issue
over 10 years ago
Contract Service Providers Gear Up to Develop Emerging Therapiesover 10 years ago
Biopharma Service Providers Address a Full Plate of Challengesover 10 years ago
Keeping it Simple: Collaborating for Success in Drug Deliveryover 10 years ago
Biomanufacturers Demand Higher Quality Standards in 2016over 10 years ago
Preventing Phase III Failuresover 10 years ago
Outsourcing Industry Marked by Considerable Investments in 2016Advertisement
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Nathan Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about rare disease treatment development and navigating the FDA’s Rare Pediatric Disease Priority Review Voucher Program.
Mirikizumab (Omvoh) achieved comprehensive disease control in 27.7% of UC patients and deep remission in 20.4% with Crohn disease at 1 year.
As ArsenalBio, TScan, Bristol Myers Squibb, and others abandon ex vivo programs for in vivo engineering, early clinical data and platform differences point to both the promise and the unresolved safety, manufacturing, and regulatory questions of generating CAR-T cells inside the body.
BNT113 plus pembrolizumab failed to significantly extend progression-free survival in a 285-patient HPV16-positive head and neck cancer trial.
Gilead will develop up to three PRO-XTEN T-cell engagers discovered by Vir Biotechnology for solid tumors in a deal worth up to $1.74 billion.
The FDA has accepted Pierre Fabre Pharmaceuticals’ resubmitted BLA for tabelecleucel, an allogeneic T-cell immunotherapy for EBV+ post-transplant lymphoproliferative disease. The FDA’s target action date is March 31, 2027.
Johnson & Johnson's guselkumab achieved up to 29% fistula remission in hard-to-treat Crohn disease subgroups, including prior biologic failures.
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