The FDA expanded Fast Track status for invikafusp alfa, Marengo Therapeutics’ TCR Vβ-targeting antibody-IL-2 fusion protein, from TMB-H colorectal cancer to TMB-H solid tumors regardless of tissue of origin.
Publication|Videos|January 26, 2024
At AAPS with CritiTech Particle Engineering Solutions
Matthew McClorey, President of CritiTech Particle Engineering Solutions, shares his insights at AAPS.
At a recent American Association of Pharmaceutical Scientists (AAPS) convention, BioPharm International sat down with Matthew McClorey, President of CritiTech Particle Engineering Solutions.
Learn more about:
- What makes CritiTech unique in the CDMO market.
- What you can expect from working with CritiTech.
- The company’s ability to formulate direct-to-site treatments from previously systemically delivered drugs with the patented Purcision platform.
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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.
The FDA launches a new rare disease development initiative, BioNTech’s BNT113 misses a progression-free survival endpoint, and Viking Therapeutics begins Phase III trials of its oral obesity candidate.
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.
FDA’s rare disease framework effort will revisit evidence expectations and manufacturing review, with public input starting Oct. 28.
BNT113 plus pembrolizumab failed to significantly extend progression-free survival in a 285-patient HPV16-positive head and neck cancer trial.
Viking Therapeutics has started two Phase 3 trials of once-daily oral VK2735, a dual GLP-1/GIP receptor agonist, in adults with obesity, with and without type 2 diabetes.
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.
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