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Janssen submits EMA filing for bladder cancer treatment 

Drug Discovery World

Patients with mUC, including FGFR-driven tumours, face a particularly poor prognosis and the need for innovative therapies remains high. N Engl J Med 2019; 381(4):338-348. Prognostic value and clinical significance of FGFR genomic alterations (GAs) in metastatic urothelial cancer patients. Expert Review of Clinical Pharmacology.

Treatment 130
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Bristol Myers Squibb Data at the EADV 30th Anniversary Congress Highlight the Growing Body of Evidence on Deucravacitinib and Scientific Advancements for Patients with Serious Dermatologic Diseases

The Pharma Data

Deucravacitinib demonstrated efficacy no matter baseline characteristics, including weight , disease severity and former treatment with biologic or non-biologic therapies. At therapeutic doses, deucravacitinib doesn’t inhibit JAK1, JAK2 or JAK3.

Disease 52
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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. A combination therapy of glecaprevir and pibrentasvir has recently been implicated in a case of liver injury.

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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. A combination therapy of glecaprevir and pibrentasvir has recently been implicated in a case of liver injury.

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

Agency IQ

FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine. First, Cathy Gelotte, a clinical pharmacology consultant, made the case that low bioavailability does not necessarily indicate a lack of efficacy.

Science 40