Biotech | June 19, 2023
Laurus Labs signs MOA with IIT Kanpur for novel gene therapy assets
Laurus will also provide funding for the clinical trials and will launch these products in India and emerging markets
Laurus will also provide funding for the clinical trials and will launch these products in India and emerging markets
The inspection closed with the facility receiving an inspection classification of NAI
Based on a subgroup analysis by PD-L1 expression from KEYNOTE-811, Merck is working with the US FDA to update the current indication for KEYTRUDA in HER2-positive gastric or GEJ adenocarcinoma
The inspection closed with zero observations
The company will submit its comprehensive response on these observations to the US FDA
Granules now has a total of 58 ANDA approvals from US FDA
Total investments could reach €70 million, of which approximately 15% in R&D and 85% in capex, that would be deployed from 2026
Diclofenac Sodium and Misoprostol Delayed Release Tablets USP, 50mg/200 mcg and 75mg/200 mcg had annual sales of USD 13 mn in the United States
Metoprolol Succinate ER Tablets are indicated for the treatment of hypertension in order to lower blood pressure.
The application is in line with Innocan's strategy to expand the scope of its combined magnesium and cannabis topical solution
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