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
Thiamine Hydrochloride Injection USP had estimated annual sales of USD 35 million in the U.S.
Acquisition delivers industry-leading research capability, and strengthens pipeline with a novel candidate for ulcerative colitis, Crohn’s disease and other autoimmune conditions
The inspection closed with zero observations
The company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection
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
Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities
Chinook Therapeutics is a clinical-stage biopharmaceutical company with two high-value, late-stage assets in development for IgA nephropathy (IgAN), a rare, progressive chronic kidney disease
The primary endpoint is to measure the change in liver stiffness measurement performed by transient elastography from Baseline to Week 52
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg and 40 mg had annual sales of USD 42 mn in the United States (IQVIA MAT April 2023)
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