Glenmark

European Pharmaceutical Review | January 03, 2017

The US Food and Drug Administration (FDA) cleared Glenmark Pharmaceutical’s investigational new drug (IND) application to initiate a phase I study of its lead candidate, GBR 1302-BEAT, in patients with HER2+ cancers....

Glenmark Pharmaceuticals | April 25, 2017

Glenmark Pharmaceuticals, a global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) cleared the company's Investigational New Drug (IND) application to initiate a first-in-human study of GBR 310, a proposed biosimilar, which will assess its pharmacokinetics in comparison to XOLAIR® (omalizumab) in healthy adult volunteers between 18 – 65 years of age....

Glenmark Pharmaceuticals Inc | October 19, 2020

Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Sirolimus Tablets, 0.5 mg, 1 mg and 2 mg, the generic version of Rapamune®1 Tablets, 0.5 mg, 1 mg and 2 mg, of PF Prism CV. According to IQVIATM sales data for the 12 month period ending August 2020, the Rapamune® Tablets, 0.5 mg, 1 mg and 2 mg market2 achieved annual sales of approximately $119.7 million*. Glenmark's current portfolio consists ...

Pharmacy Business | January 14, 2020

The government on Monday announced a collaboration with Novartis to launch a clinical trial for ‘yet to be approved’ drug inclisiran. The drug could benefit thousands of patients at risk of heart disease in coming years. The ground-breaking collaboration includes Novartis, NHS England and the National Institute for Health Research (NIHR) and Oxford University. The Department of Health and Social Care (DHSC) expects this to position the UK as a world-leading destination to develop cut...