2021 Clinical Development Clinical Pharmacology Therapies 
The Pharma Data
OCTOBER 1, 2021
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.
Metabolite Tales Blog
JULY 5, 2023
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.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Metabolite Tales Blog
JULY 5, 2023
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.
Agency IQ
SEPTEMBER 15, 2023
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
The Premier Consulting Blog
JUNE 18, 2023
This has opened new opportunities in pharmaceutical drug development, such as the ability to evaluate large complex databases and to integrate information in useful ways. One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases.
The Pharma Data
OCTOBER 15, 2020
The award honors McHutchison’s work in developing life-changing and curative therapies for patients with the hepatitis C virus. Mukul Agarwal, former vice president of Corporate Development, at Forty Seven, Inc., Axovant – Kristin Vuori was named to the board of directors at Axovant Gene Therapies Ltd.
Agency IQ
DECEMBER 11, 2023
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.” In 2021, FDA’s efforts on dose optimization came to the forefront with the announcement of Product Optimus.
Expert insights. Personalized for you.
52 
Let's personalize your content