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The rising impact of biomarkers in early clinical development

Drug Target Review

As biomarkers become increasingly relevant in indicating the workings and effects of novel therapies, their potential as valuable clinical and regulatory endpoints is also gaining recognition. Biomarkers can play a crucial role throughout clinical development, especially in early phases. Bagyinszky E, et al. 21(10):3517.

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AlgoTherapeutix Receives Regulatory Approval to Initiate Clinical Development of ATX01

The Pharma Data

15, 2020 07:15 UTC. AlgoTherapeutix recently raised a 12M€ Series A that will fund the Phase 1 and 2 clinical development of ATX01. About AlgoTherapeutix AlgoTx was founded in 2018 by Stéphane Thiroloix and Olivier Bohuon to develop topical treatments for complex pain and was incubated by Paris Biotech Santé.

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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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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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Novartis Provides Update on AVXS-101 Intrathecal Clinical Development Program

The Pharma Data

Basel, September 23 , 2020 – Novartis Gene Therapies recently received feedback from the US Food and Drug Administration (FDA) following their review of data from the STRONG study of the intrathecal (IT) formulation of AVXS-101 in older patients with spinal muscular atrophy (SMA).

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Synlogic Announces Third Quarter 2020 Conference Call & Webcast

The Pharma Data

27, 2020 /PRNewswire/ — Synlogic, Inc. Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, today announced the Company will release its third quarter 2020 financial results before the market opens on Thursday, November 5, 2020. CAMBRIDGE, Mass. ,

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Novavax Announces COVID-19 Vaccine Clinical Development Progress

The Pharma Data

30, 2020 (GLOBE NEWSWIRE) — Novavax, Inc. Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. Posted: November 2020. GAITHERSBURG, Md., Source: Novavax, Inc. . Source link.