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Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

Clinical Pharmacology & Therapeutics , 111(3), 531538. Pharmaceutical Regulations in Japan 2020. Journal of Clinical Pharmacology , 51(3), 531538. Evolving Landscape of New Drug Approval in Japan and Lags from International Birth Dates: Retrospective Regulatory Analysis. Freyr Solutions.

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COVID-19 has propelled the regulatory industry years ahead

pharmaphorum

A Timeline of COVID-19 Developments in 2020. 7 Petra Doerr, Marie Valentin, Nobumasa Nakashima, Nick Orphanos, Gustavo Santos, Georgios Balkamos & Agnes Saint-Raymond (2021) Reliance: a smarter way of regulating medical products – The IPRP survey, Expert Review of Clinical Pharmacology, 14:2, 173-177. 3, 101 (2020).

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FDA Advisory Committee Review of 2021

Eye on FDA

And speaking of divergent outcomes – one of the most notable occurrences in 2020 was the number of resignations that occurred in the wake of FDA’s decision to approve Aduhelm for Alzheimer’s Disease after an overwhelming committee vote recommending the agency decline to approve. Taking Care of AdComm Vacancies.

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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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Lilly adds to pain pipeline with Asahi Kasei licensing deal

pharmaphorum

The licensing deal comes as Lilly and partner Pfizer are waiting from a verdict from the FDA on tanezumab as a treatment for pain associated with osteoarthritis, which was supposed to be forthcoming before the end of 2020. While tanezumab is an antibody and has to be delivered by subcutaneous injection, AK1780 is orally bioavailable.

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Episode 573: Ceiling dose of ketorolac for renal colic in the ED

Pharmacy Joe

In 1989, a study in the Journal of Clinical Pharmacology compared 10, 30, and 90 mg of IM ketorolac with placebo in 126 patients with cancer pain. While all doses were more effective than placebo, there was no difference in effectiveness between 10, 30, or 90 mg of IM ketorolac. 165 patients were split evenly between the 3 groups.

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Why R&D innovation holds the key to greater patient impact

European Pharmaceutical Review

He received an MD from the Georg August University of Göttingen and completed a postdoctoral Master’s in Medical Sciences Clinical Pharmacology at the University of Glasgow. Dr Mieke Borgs has been Head of Clinical Operations Europe at BeiGene since May 2020.