Remove 2020 Remove Clinical Development Remove Clinical Pharmacology
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Janssen submits EMA filing for bladder cancer treatment 

Drug Discovery World

Europe has one of the highest rates of bladder cancer in the world 1 , with more than 203,000 patients diagnosed in 2020 alone 2. Prognostic value and clinical significance of FGFR genomic alterations (GAs) in metastatic urothelial cancer patients. Expert Review of Clinical Pharmacology. J Clin Med. 2022;11(15): 4483.

Treatment 130
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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]

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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]

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Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

However, the Coronavirus Aid, Relief, and Economic Security (CARES) Act) of 2020 included provisions to overhaul OTC drug regulation. FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine. The two sides saw nearly every finding in a different light.

Science 40