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|June 15, 2002
- BioPharm International-06-01-2002
- Volume 15
- Issue 6
Creating Effective Biopharmaceutical QA/QC Organizations: Your People are the Key
by Edward R. Arling, Ralph Dillon, and Joseph Noferi, Pharmacia GS API Biopharma Bringing a drug product to market requires that all parts of the manufacturing and validation puzzle comply with an increasing number of regulations. Managing the quality aspects for far-flung organizations can be a colossal assignment. A quality assurance unit may be the answer you need, along with finding capable, competent people and ensuring that they have the right communication tools.
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Negotiating and Structuring Strategic Alliancesover 24 years ago
Finding Funding in Biotechnology: Keeping the Companies Aliveover 24 years ago
Stem Cells and Xenotransplantation: Ethics, Patents, and Politicsover 24 years ago
Unlocking the Value of R&D: Managing the Risksover 24 years ago
Viewpoint: United Kingdom highlights biomanufacturing capabilitiesover 24 years ago
Inside Washington: Safety, Risk, and Biotechnology Regulationover 24 years ago
Criminal Penalties for Theft of Biological MaterialAdvertisement
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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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