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Cadila has filed for approval of saroglitazar for NASH in India. The drug, which could emerge as the first medicine for the indication if approved, is already being used by a million Indian patients for diabetic dyslipidemia and hypertriglyceridemia.
Site switch also could trigger ANDA approvals sidelined as Moraiya plant recovers from US FDA warning letter.
Mylan is preparing to launch a trastuzumab biosimilar in the US, while progress of developing bevacizumab and aflibercept biosimilars continues. Insulin aspart and glargine are also in Mylan’s pipeline.
Novartis thinks tropifexor may prove to be best-in-class FXR agonist, while Pfizer notes the complementary activity of its ACC and DGAT2 inhibitors. Their NASH trial collaboration is heading toward a Phase II launch in 2020.
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