Glenmark Pharma gets observations from USFDA for its Goa and Monroe facilities
A total of five observations for Goa and 17 for Monroe
A total of five observations for Goa and 17 for Monroe
The Portal BioRRAP will cater to all those seeking regulatory approval for biological research
First disclosure from PILOT study of Breyanzi in second-line large B-cell lymphoma underscores important role of cell therapy earlier in treatment paradigm
Leading pharma companies are achieving rapid, large-scale performance improvements using a multifaceted approach that realizes short-term gains & builds long-term capabilities at the same time
Purpose-built bioconjugation facility in Lonza’s Ibex Dedicate Biopark in Visp, Switzerland to support the potential commercial launch of Kodiak's lead product candidate KSI-301 for high-prevalence retinal diseases
A post approval change order is often necessary, but innovators should plan and prepare for this pre-approval. Planning alongside outsourcing partners will help ensure that only a small-scale study is needed—not a new full clinical study
The vaccine was found to have 64% efficacy against symptomatic disease and 92% against severe Covid-19
It is part of the company's CAD $30 million capital investment in the Aurora, Canada site
ZS and Quartic will collaborate to help drive resilience, increase adoption of Industry 4.0 and improve predictive decision-making across manufacturing
TPE tubing from Freudenberg also offers many different sterilization options including autoclave, gamma irradiation, x-ray, and e-beam
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