Remove 2021 Remove Clinical Development Remove Clinical Pharmacology Remove Disease
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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. Deucravacitinib is being studied in multiple immune-mediated diseases, including psoriasis, rheumatoid arthritis , lupus and inflammatory bowel disease.

Disease 52
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Metabolism of macrocyclic drugs

Metabolite Tales Blog

However, in the quest to tackle challenging disease targets with difficult drug binding sites, there is revived interest in developing this compound type to offer unique solutions. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Gangl et al.,

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Metabolism of de novo designed macrocyclic drugs

Metabolite Tales Blog

However, in the quest to tackle challenging disease targets with difficult drug binding sites, there is revived interest in developing this compound type to offer unique solutions. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Gangl et al.,

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In Silico Modeling Unveils a New Era in Rare Disease Drug Development

The Premier Consulting Blog

One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases. However, with rare diseases there may be no available treatments that could serve as SoC or active control in a clinical trial and assigning patients to placebo may be unethical.

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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. billion, compared with retail sales of $0.5

Science 40
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TLC Provides Corporate Update at Investor Conference – Dec 18, 2020

The Pharma Data

In its Phase II clinical trial, TLC599 significantly reduced pain at and through every scheduled visit through six months. EXCELLENCE will evaluate the efficacy and safety of both a single and a repeated dose of TLC599; topline data of TLC’s leading program is expected in the second half of 2021.

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Analysis Life Sciences Thank You The FDA and oncology: 2023 year in review

Agency IQ

Diagnostic and therapeutic advances in oncology have moved many cancer types into the categories of curable or treatable diseases. For example, FDA’s Project Renewal was announced in 2021 as a concerted effort to update labeling information for “older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date.”

FDA 40