Novo Nordisk licenses a once-weekly oral GLP-1/GIP candidate, uniQure reports 48-month Huntington’s disease data, and AstraZeneca invests $2 billion in Summit Therapeutics.
|Articles|September 1, 2003
- BioPharm International-09-01-2003
- Volume 16
- Issue 9
Manufacturing in a Global Marketplace: Reference Matrices on Regulations for Classified (Environmentally Controlled) Areas
The complex world of international regulations, standards, and guidelines on sterile manufacturing of parenteral products is deciphered and reduced to a set of matrix tables.
Advertisement
Articles in this issue
about 23 years ago
Sterile Fill Facilities: Problems and Resolutionsabout 23 years ago
CROs Hope for Second Half Research BurstAdvertisement
Related to this article
Novo gains global rights, excluding Greater China, to HRS-1596, a phase 1-ready GLP-1/GIP dual receptor agonist that Hengrui says has potential for once-weekly oral dosing in obesity and type 2 diabetes.
NouvSight001 isn't limited to the RPE65-mutation subset current gene therapy treats, potentially reaching more of the 1.5 million with RP worldwide.
Updated 36-month data in 15 high-dose patients showed 80% slowing on cUHDRS, while the 48-month cUHDRS result did not reach statistical significance. uniQure attributes the gap to attrition in the external control, and the FDA is reviewing a BLA based on the 36-month data.
Ivonescimab, in phase 3 trials across 8 tumor types, will be paired with sonesitatug vedotin in new gastrointestinal cancer trials.
Today’s biopharma news highlights how new data could reduce treatment burden, improve excipient information sharing, and shape future options for patients with difficult-to-treat cancers.
Daiichi Sankyo and Merck pulled ifinatamab deruxtecan's FDA filing in small cell lung cancer after a 187-patient trial fell short.
IPEC’s EIP user guide streamlines information exchange and response times while increasing accuracy through standardization.
Advertisement
Advertisement