Remove 2020 Remove Clinical Development Remove Clinical Pharmacology
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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. Clinical Pharmacology and Therapeutics.

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TLC Provides Corporate Update at Investor Conference – Dec 18, 2020

The Pharma Data

The trial remains on-track to complete enrollment of all 500 patients in the United States and Australia before the end of 2020, despite the worsening of the COVID-19 pandemic. In its Phase II clinical trial, TLC599 significantly reduced pain at and through every scheduled visit through six months. SOUTH SAN FRANCISCO, Calif.

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Biomarker identification in the realm of rare diseases

Drug Target Review

In 2020, 78 percent of orphan drugs and biologics approved were targeted therapies. At Debiopharm, he has overseen both preclinical and clinical pharmacology of assets from phase I to III.

Disease 59
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Sage Therapeutics and Biogen Initiate Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for Zuranolone for the Potential Treatment of Major Depressive Disorder (MDD)

The Pharma Data

Data from the completed studies of zuranolone in the LANDSCAPE and NEST clinical development programs, including data from the ongoing open-label SHORELINE Study in MDD, as well as data from the completed clinical pharmacology studies, will comprise the full submission package. Food & Drug Administration.

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Pharmaron Acquires Absorption Systems in the USA

The Pharma Data

9, 2020 00:00 UTC. HK) (“Pharmaron”), a fully integrated contract research and manufacturing organization offering laboratory, CMC and clinical development services for the life science industry, announced today that it has acquired 100% of the equity of Absorption Systems for up to US$137.5 Limited (Stock Code: 300759.SZ/3759.HK)

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Metabolism of macrocyclic drugs

Metabolite Tales Blog

With metabolic stability in mind, we take a look at the metabolism of some FDA approved synthetic macrocyclic drugs, and a few of those that were/are in clinical development where metabolism data was available. link] [13] A user’s guide to lorlatinib. Nagasaka et al., Critical Reviews in Oncology/Hematology, 151, 102969, [link]. [16]

Drugs 52
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Metabolism of de novo designed macrocyclic drugs

Metabolite Tales Blog

With metabolic stability in mind, we take a look at the metabolism of some FDA approved synthetic macrocyclic drugs, and a few of those that were/are in clinical development where metabolism data was available. link] [13] A user’s guide to lorlatinib. Nagasaka et al., Critical Reviews in Oncology/Hematology, 151, 102969, [link]. [16]