Remove 2020 Remove Clinical Development Remove Therapies
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Getting the Pulse on Biopharma and Biotech Companies: Differing Perspectives on Clinical Development

PPD

To keep a pulse on this rapidly changing industry, the PPD clinical research business of Thermo Fisher Scientific surveyed 150 leaders in the biopharma and biotech industries for the second consecutive year. Differences in size, resources and agility have led the two groups to take different approaches to clinical development.

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J&J, Legend Biotech Launch Rolling Submission for CAR-T Therapy for Multiple Myeloma | 2020-12-22

The Pharma Data

Legend will receive $75 million from J&J as a clinical development-based milestone payment, per a 2017 collaboration pact. Cilta-cel also won a Breakthrough Therapy designation in China in August. Source link.

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Analytical Testing Considerations for Gene Therapy Products

The Premier Consulting Blog

The FDA’s January 2020 guidance, Chemistry, Manufacturing and Control (CMC) [1] Information for Human Gene Therapy Investigational New Drug Applications (INDs), outlines the analytical methods that define the quality, safety and efficacy of gene therapy therapeutics.

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Regulatory Trends in Cell and Gene Therapies

Advarra

The field of cell and gene therapies (CGT) is constantly evolving, and there has been significant progress in this area of research. However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines.

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Bayer extends clinical development program for finerenone with Phase II study investigating the initial combination therapy with empagliflozin in patients with chronic kidney disease and type 2 diabetes

The Pharma Data

Bayer announced today the initiation of the CONFIDENCE study, a Phase II, three-arm study that will investigate simultaneous initial combination therapy with finerenone and the SGLT2 inhibitor empagliflozin, compared with finerenone alone and empagliflozin alone respectively in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D).

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Amgen To Webcast Investor Calls At ESMO 2020

The Pharma Data

16, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) will host two webcast calls for the investment community in conjunction with the European Society for Medical Oncology (ESMO) 2020 Virtual Congress. 20, 2020, at 11:00 a.m. THOUSAND OAKS, Calif. On Sunday, Sept. PDT, David M. Reese , M.D., Reese , M.D., On Monday, Sept.

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Gannex Appoints Former Takeda Head of Liver Disease Clinical Development Melissa Palmer, MD as Chief Medical Officer

The Pharma Data

29 , 2020 /PRNewswire/ — Gannex, a wholly owned company of Ascletis Pharma Inc. Prior to joining Gannex, Dr. Prior to joining Gannex, Dr. Palmer was Head of Liver Disease Clinical Development at Takeda Pharmaceuticals. The clinical trial application of ASC09F has been approved. SHANGHAI , Nov.