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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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Vamorolone

New Drug Approvals

Hoffman, Efficacy and safety of vamorolone vs placebo and prednisone among boys with duchenne muscular dystrophy: a randomized clinical trial, JAMA Neurol. 79 (2022) 1005–1014. [71] 79 (2022)1005–1014 Bioorg. Shale, U.J. Reeves, E.P. Hoffman, K. Nagaraju, J.M. Damsker, J.M. 2020, 117,24285−24293. Alliance 2019, 2,No.

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Landiolol

New Drug Approvals

21 December 2022. “Pharmacokinetics of landiolol hydrochloride, a new ultra-short-acting beta-blocker, in patients with cardiac arrhythmias” Clinical Pharmacology and Therapeutics. 24 August 2022. Further reading Shiga T (June 2022). . ^ “Details for: Sibboran” Health Canada. Procedure no.:

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Antibody Drug Conjugates: windows of opportunity

Drug Target Review

However, a more detailed look into the clinical data suggests that there is room for further dose optimisation, and this is exemplified by the small molecule drug Sotorasib. 2022 Nov 14 [cited 2023 Apr 6];40(11):1255–63. Translational and Clinical Pharmacology [Internet]. 2022 [cited 2023 Feb 10];30(2):71.

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Zelatriazin

New Drug Approvals

. ^ Yin, Wei; Han, David; Khudyakov, Polyna; Behrje, Rhett; Posener, Joel; Laurenza, Antonio; Arkilo, Dimitrios (August 2022). “A phase 1 study to evaluate the safety, tolerability and pharmacokinetics of TAK-041 in healthy participants and patients with stable schizophrenia” British Journal of Clinical Pharmacology.

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Astellas and Seagen Announce Initial Results of PADCEV® (enfortumab vedotin-ejfv) in Patients with Muscle-Invasive Bladder Cancer Not Eligible for Cisplatin Chemotherapy

The Pharma Data

– La te-breaking data from Cohort H of EV-103 trial to be presented at the 2022 ASCO Genitourinary Cancers Symposium –. Data from this late-breaking abstract will be included in an oral presentation (Abstract 435) at the 2022 ASCO Genitourinary Cancers Symposium (ASCO GU) on February 18. Astellas Pharma Inc. Astellas”) and Seagen Inc.

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Eplontersen

New Drug Approvals

December 2022). “Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of Clinical Pharmacology. .; Viney, Nicholas J.; Schneider, Eugene; Guo, Shuling; Henry, Scott; et al. 88 (12): 5389–5398. doi : 10.1111/bcp.15468.