Shilpa Biologicals partners with mAbTree Biologics AG for a novel immunooncology asset

This program aims to develop a fully human monoclonal antibody against a novel immune checkpoint protein that enables T cell activation

Nectar Lifesciences receives 7 observations from EDQM for API facility

The European regulator will conduct a re-inspection of the facility to verify the compliance

Bionova opens Fremont process development and pilot plant

Briefs: Emcure and Relonchem

USFDA inspection at Emcure Pharmaceuticals API facility

Briefs: Syngene International and Cipla

Cipla Limited has received final approval from the USFDA for the New Drug Application submitted for ‘Nilotinib Capsules 50, 150 and 200 mg’

Granules India acquires Swiss Senn Chemicals to foray into peptide and CDMO business

The acquisition aligns with Granules' vision to enter the rapidly expanding peptide-based anti-diabetic and anti-obesity market

USFDA issues Form-483 for Piramal Pharma's facility at Turbhe

Observations are largely around improvement of procedures and practices

Orchid Pharma's Alathur API facility successfully completes USFDA inspection

The Alathur facility specializes in the production of Cephalosporin antibiotics

Briefs: Caplin Point Laboratories, Hikal and Cipla

Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru

CuraTeQ Biologics receives positive opinion for biosimilar Dyrupeg from EMA

Dyrupeg will be available as 6 mg solution for injection in prefilled syringe and is intended for the reduction in the duration of neutropenia