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Results For "clinical-development"

548 News Found

US FDA accepts supplemental new drug application for Jardiance for adults with chronic kidney disease
News | January 23, 2023

US FDA accepts supplemental new drug application for Jardiance for adults with chronic kidney disease

The supplemental New Drug Application is based on results from the landmark EMPA-KIDNEY phase III trial


Dr. Reddy’s completes clinical studies of its rituximab biosimilar for filing in the U.S., Europe
Drug Approval | January 21, 2023

Dr. Reddy’s completes clinical studies of its rituximab biosimilar for filing in the U.S., Europe

Following successful completion of full set of clinical studies of proposed rituximab biosimilar candidate DRL_RI, Dr. Reddy’s will now prepare to file in the United States, European Union and other regions


CNS Pharmaceuticals appoints Faith L. Charles as Chair of the Board of Directors
People | January 04, 2023

CNS Pharmaceuticals appoints Faith L. Charles as Chair of the Board of Directors

Over 30 years of deep life sciences industry experience with a wide range of expertise in corporate governance, capital markets, licensing and strategic collaborations


Ablaze and Yonghe Pharma initiate development and manufacturing agreement for targeted radiopharmaceutical therapies
News | December 28, 2022

Ablaze and Yonghe Pharma initiate development and manufacturing agreement for targeted radiopharmaceutical therapies

Yonghe as the CDMO partner will provide production process development and cGMP manufacturing services for Ablaze


Lynparza in combination with Abiraterone and Prednisone approved in the EU as treatment for metastatic castration-resistant prostate cancer
Clinical Trials | December 22, 2022

Lynparza in combination with Abiraterone and Prednisone approved in the EU as treatment for metastatic castration-resistant prostate cancer

First PARP inhibitor and new hormonal agent combination approved for these patients in Europe


Astellas, Seagen and Merck announce FDA acceptance of sBLA for PADCEV for urothelial cancer
Drug Approval | December 20, 2022

Astellas, Seagen and Merck announce FDA acceptance of sBLA for PADCEV for urothelial cancer

This combination has the potential to be the first treatment option combining an antibody-drug conjugate plus an immunotherapy in this treatment setting


Aurigene reports results of AUR101 in phase II study in US patients
News | December 19, 2022

Aurigene reports results of AUR101 in phase II study in US patients

AUR101, with a good ADME/PK profile and high bioavailability, has demonstrated inhibition of IL-17A in whole blood from psoriasis patients


Emmes appoints Ching Tian as Chief Innovation Officer
People | December 16, 2022

Emmes appoints Ching Tian as Chief Innovation Officer

Her previous role at Novartis, where she was general manager, data & digital, in global drug development, also included accountability for driving the DCT strategy, programs and platforms


Biocon initiates clinical study of Itolizumab for ulcerative colitis in India
Clinical Trials | December 15, 2022

Biocon initiates clinical study of Itolizumab for ulcerative colitis in India

This is a phase two randomized, double-blind, parallel-group, placebo and active-controlled study


Evonik invests in US based biopharma company ‘Allay Therapeutics’
News | December 13, 2022

Evonik invests in US based biopharma company ‘Allay Therapeutics’

Implants from the U.S. startup Allay Therapeutics are designed to relieve pain after knee surgery for up to three weeks