Presentations include new data on investigational medicines – favezelimab (MK-4280), zilovertamab vedotin (MK-2140) and nemtabrutinib – as well as KEYTRUDA (pembrolizumab) in multiple blood cancers
Results showed a statistically significant and clinically meaningful improvement in investigator-assessed progression-free survival
Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints
Phase-III trials were conducted for safety, and immunogenicity in around 3,100 subjects, in 14 trial sites across India (supported by BIRAC)
With this QIP placement, the Dhanuka group, which took over the company in 2018, is also meeting its mandatory obligation to dilute 15 percent stake in the company by March 2023
Topiramate Extended-Release capsule had annual sales of US $68.8 mn in the United States according to IQVIA data (IQVIA MAT Sep 2022)
Shilpa Medicare Ltd's finished dosage form manufacturing facility, Unit IV, situated at Pharma SEZ, Jadcherla, Telangana has received Health Canada GMP approval
TPE tubing is ideal for pharmaceutical bioprocessing applications because it can be welded to existing tubing lines, and heat-sealed to allow for easy, fast, and safe fluid transport in biopharma processes
This is the second line opened this year for parenteral drug product clinical and commercial manufacturing, with an annual capacity of 10 million units
This product is based on Osmotic Controlled Release Oral Delivery System technology
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