Zydus’ new drug application of Desidustat tablets accepted by China Medical System Holdings

Desidustat, administered orally is a novel, oral Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI) for treating anaemia in Chronic Kidney Disease (CKD) patients

Sentynl Therapeutics receives marketing authorization for Nulibry from UK MHRA

NULIBRY is a first-in-class synthetic cPMP substrate replacement therapy to reduce the risk of mortality in patients with MoCD Type A

Evotech and Variant Bio partner to develop fibrosis treatment

Commercial terms include research funding and milestones and/or royalty payments to Evotec based on the success of the program

Mac-Chem Products (India)’s Boisar facility renews EU-GMP certification

Vertex announces advancements of Suzetrigine in acute and neuropathic pain

Breakthrough Therapy designation for pain associated with DPN granted by FDA

USFDA grants ODD to NM5072 for treatment of Paroxysmal Nocturnal Hemoglobinuria

NM5072 is an anti-Properdin antibody that selectively blocks the alternative pathway while maintaining the integrity of the classical pathway required for fending off infections

Positive data for Roche multiple sclerosis injection

US FDA and EMA accepted filings based on the data from OCARINA II, with EU approval anticipated mid-2024 and U.S. approval anticipated September 2024

Novartis reports data from trial of IgA nephropathy treatment

IgAN is a heterogeneous, progressive, rare kidney disease and is a major cause of chronic kidney disease worldwide

Croda and AAHI partner to drive innovation in vaccine development

The exclusive agreement between AAHI and Croda includes a collaborative effort in research and development

Granules India’s Unit V facility in Visakhapatnam completes USFDA inspection with zero 483 observations

This facility manufactures APIs & formulations of oncology and non-oncology products.