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Glenmark Pharma to launch phase 1 trial in solid tumors for GBR 1342

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Glenmark Pharmaceuticals is planning to launch a Phase 1 trial in solid tumors for its CD38xCD3 bispecific antibody GBR 1342. The decision is driven by recent findings derived from a non-interventional human study utilizing a clinically validated CAN script platform. GBR 1342 is based on Glenmark’s proprietary BEAT platform and simultaneously targets CD38 and the … Read more

USFDA inspects Alembic Pharmaceuticals’ general oral solid formulation facility

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The US Food and Drug Administration (USFDA) has completed an inspection at Alembic Pharmaceuticals’ general oral solid formulation facility at Panelav, Gujarat, India. The facility was inspected from October 22, 2018 to October 26, 2018. At the end of the inspection, the US FDA issued a Form 483 with four procedural observations. The company will … Read more

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