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Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

Clinical Pharmacology & Therapeutics , 111(3), 531538. Journal of Clinical Pharmacology , 51(3), 531538. Understanding the key aspects of the regulatory framework and staying up-to-date with the latest developments is crucial for companies seeking to enter the Japanese market. References Tanaka, M., Freyr Solutions.

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The future of medical cannabis development in Europe

European Pharmaceutical Review

An observational study of safety and clinical outcome measures across patient groups in the United Kingdom Medical Cannabis Registry. Expert Review of Clinical Pharmacology. Plant cannabinoids: a neglected pharmacological treasure trove. 2022 Jan;56:8-14. 2022 Jan 1:3493-507. 2022 Aug 5. Mechoulam R.

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AbbVie extends Gedeon Richter alliance that gave it Vraylar

pharmaphorum

billion in 2022. AbbVie’s chief scientific officer Tom Hudson said the aim of the new alliance with Gedeon Richter will be to “provide additional insights into our understanding of cariprazine’s clinical pharmacology and explore novel chemistry to identify new dopamine receptor modulators.”

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Zydus gets Orphan Drug Designation from USFDA for ZYIL1 to treat Cryopyrin Associated Periodic Syndrome

Express Pharma

In September 2022, Zydus had announced positive Phase 2 proof-of-concept (POC) study in CAPS patients, and the publication of Phase 1 study results in Clinical Pharmacology in Drug Development, supporting the advancement of ZYIL1 into pivotal clinical trials in CAPS patients.

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New Initiative of the US FDA: The Role of Pharmacodynamic Biomarkers for the Development of Biosimilar

PharmaShots

A recent study published in the January 2023 issue of Clinical Pharmacology and Therapeutics described essential characteristics of a PD biomarker for biosimilar development.

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Recommended Medical Reference

RX Note

Adverse Drug Reaction Drug Induced Diseases, 2018 Meyler's Side Effects of Drugs, 2015 Antibiotics The Sanford Guide to Antimicrobial Therapy, 2022 Breastfeeding Briggs' Drugs in Pregnancy and Lactation, 2021 Hale's Medications and Mothers' Milk, 2021 Clinical Practice Applied Therapeutics, 2018 Conn’s Current Therapy, 2022 Current Medical Diagnosis (..)

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Uncovering the potential of ADCs to target tumours

European Pharmaceutical Review

This covers nonclinical drug safety, translational and clinical pharmacology, drug metabolism and pharmacokinetics (DMPK) and pharmacometrics. 2022; 7(93) Maecker et al. Exploration of the antibody–drug conjugate clinical landscape. References Fu et al. Signal Transduct Target Ther. 2023;15(1) Shastry et al.