LumaLex Law's Dustin Robinson explains why retatrutide compounding remains illegal regardless of the Seventh Circuit's pending classification ruling.
|Articles|June 15, 2015
- BioPharm International-06-15-2015
- Volume 2015 eBook
- Issue 1
Protecting Intellectual Property in Engagements with CMOs
Author(s)Jennifer L. Collins
Important IP contractual provisions should be included when working with CMOs.
Advertisement
Biotechnology and pharmaceutical companies often engage contract CMOs to assist with the development of their drugs. This type of arrangement naturally involves the development of intellectual property (IP), so it is important for both the CMO and the sponsor to identify pre-existing intellectual property and also define how rights to new IP will be allocated, protected, and enforced by and between the companies.
Articles in this issue
over 11 years ago
QRM Tools for Contract Biomanufacturingover 11 years ago
Fill/Finish Trendsover 11 years ago
Biopharma Advances Demand Specialized Expertiseover 11 years ago
Taking a “Development-by-Design” Approach to Cell TherapiesAdvertisement
Related to this article
Artiva Biotherapeutics will present data on AlloNK, an allogeneic, non-genetically modified NK cell therapy given with rituximab, in refractory rheumatoid arthritis, Sjögren disease and systemic sclerosis at ACR Convergence 2026, ahead of a planned phase 3 trial in rheumatoid arthritis.
Novartis has secured an exclusive worldwide license to ABO2203, Abogen's investigational mRNA-encoded CD19xCD3 T-cell engager designed to produce the bispecific inside the body to reset B cells in autoimmune disease. The agreement also includes options on other programs built on Abogen's RNA platform.
The 15-month project could let living cell therapies ship and store at room temperature, cutting cold-chain costs that limit patient access.
A planned phase 3 trial will test the TROP2 ADC and PD-1/VEGF bispecific together in 1st-line triple-negative breast cancer.
Following an FDA meeting, Wave Life Sciences plans a single 2-year registrational trial of WVE-006, its GalNAc-conjugated RNA editing oligonucleotide for alpha-1 antitrypsin deficiency, with a 1-year interim analysis that could support accelerated approval based on biomarkers.
Patients suffered pyrogenic reactions before Fresenius Kabi recalled 3 contaminated batches at its 430,000-sq-ft Melrose Park, Ill., biologics plant.
Sanofi is paying Regeneron up to $8 billion to co-develop REGN20423 and 3 other long-acting antibodies beyond dupilumab (Dupixent).
Advertisement
Advertisement