Shots:
The EC has approved Ondibta, a biosimilar insulin glargine pre-filled pen, reference medicine Lantus and SoloStar, developed and registered by Gan & Lee Pharmaceuticals, anticipated launch by early 2027
Ondibta is approved for treating diabetes mellitus in pts (age≥ 2 yrs.) and matches Lantus, SoloStar in safety, quality, and efficacy
In Dec 2018, Sandoz partnered with…
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FDA has granted IND clearance to initiate its P-II trial of ASC30 (40, 60 & 80mg) vs PBO in ~100 pts with type 2 diabetes mellitus, with enrolment expected to begin in Q1’26
Trial will assess mean change in HbA1c up to 13wks. as 1EP & 2EPs will incl. mean change in fasting blood…

