News | May 22, 2022
Govt. launches single national portal for biotech researchers and start-ups
The Portal BioRRAP will cater to all those seeking regulatory approval for biological research
The Portal BioRRAP will cater to all those seeking regulatory approval for biological research
Dupixent is the first and only medicine indicated to treat eosinophilic esophagitis in the United States; approval granted more than two months ahead of USFDA’s Priority Review action date
If approved, ABBV-951 will offer patients the first continuous subcutaneous delivery of carbidopa/levodopa prodrugs
According to IQVIA sales data for the 12-month period ending March 2022, the Zytiga tablets, 500 mg market achieved annual sales of approximately US $ 260.2 million
First disclosure from PILOT study of Breyanzi in second-line large B-cell lymphoma underscores important role of cell therapy earlier in treatment paradigm
Risk management plans can serve as a safeguard, helping manufacturers prepare for and respond to hazards that could lead to drug supply disruptions and shortages
A primary investment of Rs 194.4 crore has been made
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
Phase I trial in Rwanda and South Africa aims to evaluate mRNA HIV vaccine antigen for safety and immunogenicity and strengthen regional scientific capacity
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
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