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Zydus receives USFDA approval to conduct Phase II(b) clinical trial for Usnoflast, a novel oral NLRP3 inflammasome inhibitor in patients with ALS

Express Pharma

This study consists of a 36-week treatment phase, followed by a 16-week open-label extension. 1162 Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZYIL1 in Three Patients with Cryopyrin-Associated Periodic Syndromes, Clinical Pharmacology in Drug Development, 2023, 0(0) 18. DOI: 10.1002/cpdd.1162

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Clinical Pharmacology by ClinicalKey

RX Note

Introduction Clinical Pharmacology powered by ClinicalKey provides current, dependable drug information, including off-label indications, to guide treatment recommendations. Drug Class Overviews Provides information on therapeutic use, comparative efficacy, adverse reactions and drug interactions.

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FDA Releases Draft Labeling Guidance for Biosimilar Products

Big Molecule Watch

Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.” The fictitious example provided in the 2023 Draft Guidance is “replicamab-cznm.”

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AbbVie extends Gedeon Richter alliance that gave it Vraylar

pharmaphorum

Vraylar, sold in some markets as Reagila, was first approved in 2015 for schizophrenia and bipolar disorder, with its label extended in 2017 to include maintenance treatment of schizophrenia and again in 2019 for bipolar depression.

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Top 9 Takeaways From 2232 People With Hashimoto’s

The Thyroid Pharmacist

When it leaks into the bloodstream, the body does not recognize it, and labels the structure as a foreign invader and attacks it. Gluten can have a significant impact on the thyroid because of a phenomenon called molecular mimicry, which works like this: gluten can leak into the bloodstream, as it can create permeability in the gut barrier.

Immunity 111
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Twenty Women Leaders In Healthcare Industry

PharmaShots

and medical doctor in clinical pharmacology Other Affiliations: She is a member of the Board of Directors of L’Oréal S.A and Banco Bilbao Vizcaya Argentaria S.A LinkedIn Total experience: 16 yrs. Present company and time period: Johnson & Johnson (13 yrs.