Drug Patent Watch

DECEMBER 30, 2024

The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. Types of Drug Applications The PMDA accepts three main types of drug applications: Investigational New Drug (IND) : Required for conducting clinical trials in Japan.

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Generic Drugs Bioequivalency Development Drugs 52

Camargo

NOVEMBER 11, 2020

The speed of the submission in January 2020 and approval in October 2020 was attributed to the retrospective testing of available tumor tissue samples from patients enrolled in three clinical trials that led to the accelerated approval of larotrectinib.

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Development Bioequivalency Generic Drugs Production 242

Pharmaceutical Technology

OCTOBER 28, 2022

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug.

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Bioequivalency Production Contamination Branding 130

XTalks

FEBRUARY 8, 2021

In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options. Biosimilars are the “generic” drugs of the biopharma world.

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Production Insulin Branding Generic Drugs 78

The Pharma Data

DECEMBER 17, 2020

Patient enrollment of EXCELLENCE pivotal trial reaches 98%. The trial remains on-track to complete enrollment of all 500 patients in the United States and Australia before the end of 2020, despite the worsening of the COVID-19 pandemic. The Phase I clinical trial is ongoing in Taiwan in Australia, with results expected in 2021.

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Clinical Trials Clinical Trials Trials Containment 40

Druggist

MARCH 25, 2021

As with other drugs, once a patent expires, other manufactures start to produce generic or new brands of the same pill (desogestrel). New generic drugs are usually cheaper than original patent medicine, therefore switch in prescribing follows in the NHS. Bioequivalent studies may involve humans or animals (EMA, 2012). .

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Branding Bioequivalency Pharmacy Generic Drugs 98

Drug Patent Watch

JANUARY 7, 2025

Generic drugs play a crucial role in providing affordable medication options to patients. However, many individuals still harbor misconceptions and doubts about the efficacy and safety of generic alternatives. What Are Generic Drugs?

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Generic Drugs Drugs Branding Bioequivalency 89