Roche gains exclusive global rights to ZW209, a DLL3×CD3×CD28 trispecific T-cell engager designed for CD28 co-stimulation. A phase 1 study in small cell lung cancer and other neuroendocrine tumors is underway.
|Articles|June 15, 2003
- BioPharm International-06-01-2003
- Volume 16
- Issue 6
SOX in the Boardroom: What the Sarbanes?Oxley Act Means to You
Author(s)Penny Cass
by Penny Cass, BioPharm International Stay current on the changes in corporate governance regulations ? whether your company is public or private, in the United States or elsewhere. As a capital-intensive industry, many of our third-party associations are going to require that biopharmaceutical companies comply with the new regulations to receive financing. The trend to regulate corporate governance activities hasn't ended ? more rules promulgated by more government entities should be anticipated.
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A Treasury proposed rule would restrict certain US investments in biotechnology in China and other countries of concern, raising questions about how cross-border licensing and joint venture deals will be treated.
Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about the regulatory and manufacturing hurdles facing rare disease drug developers.
Rohit Tripathi, vice president of industry strategy, consumer packaged goods, and manufacturing at RELEX Solutions, explains where cold-chain planning still breaks down and why biopharma supply chain leaders should use AI to act on data sooner, with humans making the final call.
The FDA grants accelerated approval to Ultomiris for IgA nephropathy, Alcon acquires Neurotech and its MacTel cell therapy for $550 million, and BioNTech and Bristol Myers Squibb add Trodelvy to a phase 3 trial in triple-negative breast cancer.
Zylidac will test whether optogenetic cell lines that hit 21 g/L in small-scale CHO runs can deliver higher-yield complex biologics at GMP scale.
Revakinagene taroretcel (Encelto), the only FDA-approved MacTel therapy, slowed photoreceptor loss by up to 54.8% vs sham in phase 3 trials.
BioNTech and Bristol Myers Squibb will replace chemotherapy with Gilead’s TROP2-directed ADC sacituzumab govitecan in the Phase 3 ROSETTA Breast-01 trial of PD-L1×VEGF-A bispecific pumitamig in PD-L1-low or -negative TNBC.
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BioNTech, BMS to Pair Pumitamig With Trodelvy in Phase 3 First-Line TNBC Trial
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