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.
|Articles|February 15, 2002
- BioPharm International-02-01-2002
- Volume 15
- Issue 2
Sale of Your Product Can Prevent Patenting: How to Avoid the On-Sale Bar
Author(s)Tom Brody
By Tom Brody, DNAX Research Institute, pp. 38-42. Early sale or offers to sell an invention may result in the rejection of a patent application under 35 U.S.C. 102(b). Such a rejection is called "the on-sale bar," and it permanently prevents patenting of an invention.
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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.
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.
FDA reviews a proposed Keytruda biosimilar, Roche expands its obesity pipeline with an RNAi deal, and guselkumab shows promise for fistula remission in Crohn disease.
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